Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol A mobile phone intervention increases physical activity in people with cardiovascular disease: Results from the HEART randomized controlled trial CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial [Effects of a smoking cessation program including telephone counseling and text messaging using stages of change for outpatients after a myocardial infarction]. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials Using mobile technology to support lower-salt food choices for people with cardiovascular disease: protocol for the SaltSwitch randomized controlled trial The remote exercise monitoring trial for exercise-based cardiac rehabilitation (REMOTE-CR): a randomised controlled trial protocol Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol Effect of a reminder system using an automated short message service on medication adherence following acute coronary syndrome Behavioural intervention to increase physical activity among patients with coronary heart disease: protocol for a randomised controlled trial. Association of Diet, Exercise, and Smoking Modification With Risk of Early Cardiovascular Events After Acute Coronary Syndromes An Internet- and Mobile-Based Tailored Intervention to Enhance Maintenance of Physical Activity After Cardiac Rehabilitation: Short-Term Results of a Randomized Controlled Trial A text messaging intervention to promote medication adherence for patients with coronary heart disease: a randomized controlled trial. Evaluation of a Telemedicine Service for the Secondary Prevention of Coronary Artery Disease Psychosocial factors and medication adherence among patients with coronary heart disease: A text messaging intervention
Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease , providing access to such interventions is a major challenge . This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk . Methods and analysis R and omised controlled trial with 6 months of follow-up to evaluate the feasibility , acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care .  A total of 720 patients with coronary artery disease will be r and omised to either st and ard care or the TEXT ME intervention . The intervention group will receive multiple weekly text messages that provide information , motivation , support to quit smoking ( if relevant ) and recommendations for healthy diets and exercise . The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months . Secondary end points include a change in systolic blood pressure , smoking status , quality of life , medication adherence , waist circumference , physical activity levels , nutritional status and mood at 6 months . Process outcomes related to acceptability and feasibility of TEXT ME will also be collected . Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee — Westmead . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences . Clinical trials registration number ACTRN12611000161921 Aim To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease ( IHD ) . Methods and results In this single-blind , parallel , two-arm , r and omized controlled trial adults ( n = 171 ) with IHD were r and omized to receive a mobile phone delivered intervention  ( HEART ; n = 85 ) plus usual care , or usual care alone ( n = 86 ) . Adult participants aged 18 years or more , with a diagnosis of IHD , were clinical ly stable as out patients , able to perform exercise , able to underst and and write English , and had access to the Internet . The HEART ( Heart Exercise And Remote Technologies ) intervention involved a personalized , automated package of text messages and a secure website with video messages aim ed at increasing exercise behaviour , delivered over 24 weeks . All participants were able to access usual community-based cardiac rehabilitation , which involves encouragement of physical activity and an offer to join a local cardiac support club . All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake ( PVO2 ; primary outcome ) , self-reported physical activity , health-related quality of life , self-efficacy and motivation ( secondary outcomes ) . Results showed no differences in PVO2 between the two groups ( difference −0.21 ml kg−1 min−1 , 95 % CI : −1.1 , 0.7 ; p = 0.65 ) at 24 weeks . However significant treatment effects were observed for selected secondary outcomes , including leisure time physical activity ( difference 110.2 min/week , 95 % CI : −0.8 , 221.3 ; p = 0.05 ) and walking ( difference 151.4 min/week , 95 % CI : 27.6 , 275.2 ; p = 0.02 ) . There were also significant improvements in self-efficacy to be active ( difference 6.2 % , 95 % CI : 0.2 , 12.2 ; p = 0.04 ) and the general health domain of the SF36 ( difference 2.1 , 95 % CI : 0.1 , 4.1 ; p = 0.03 ) at 24 weeks . The HEART programme was considered likely to be cost-effective for leisure time activity and walking . Conclusions A mobile phone intervention was not effective at increasing exercise capacity over and above usual care . The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk . In this project , we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice . Consumer Navigation of Electronic Cardiovascular Tools ( CONNECT ) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Isl and er and non-indigenous adults , recruited through primary care , at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care . Methods and analysis R and omised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk . The trial will be augmented by formal economic and process evaluations to assess acceptability , equity and cost-effectiveness of the intervention . The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management . The programme is electronically integrated with the primary care provider 's software and will include interactive smart phone and Internet platforms . The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline -recommended blood pressure ( BP ) and cholesterol targets . Secondary outcomes include change in mean BP and fasting cholesterol levels , proportion meeting BP and cholesterol targets separately , self-efficacy , health literacy , self-reported point prevalence abstinence in smoking , body mass index and waist circumference , self-reported physical activity and self-reported medication adherence . Ethics and dissemination Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences Clinical Trials registration number ACTRN12613000715774 Objective Cardiac rehabilitation ( CR ) is pivotal in preventing recurring events of myocardial infa rct ion ( MI ) . This study aims to investigate the effect of a smartphone-based home service delivery ( Care Assessment Platform ) of CR ( CAP-CR ) on  CR  use and health outcomes compared with a traditional , centre-based programme ( TCR ) in post-MI patients . Methods In this unblinded r and omised controlled trial , post-MI patients were r and omised to TCR ( n=60 ; 55.7±10.4 years ) and CAP-CR ( n=60 ; 55.5±9.6 years ) for a 6-week CR and 6-month self-maintenance period . CAP-CR , delivered in participants ’ homes , included health and exercise monitoring , motivational and educational material delivery , and weekly mentoring consultations . CAP-CR uptake , adherence and completion rates were compared with TCR using intention-to-treat analyses . Changes in clinical outcomes ( modifiable lifestyle factors , biomedical risk factors and health-related quality of life ) across baseline , 6 weeks and 6 months were compared within , and between , groups using linear mixed model regression . Results CAP-CR had significantly higher uptake ( 80 % vs 62 % ) , adherence ( 94 % vs 68 % ) and completion ( 80 % vs 47 % ) rates than TCR ( p<0.05 ) . Both groups showed significant improvements in 6-minute walk test from baseline to 6 weeks ( TCR : 537±86–584±99 m ; CAP-CR : 510±77–570±80 m ) , which was maintained at 6 months . CAP-CR  showed slight weight reduction ( 89±20–88±21 kg ) and also demonstrated significant improvements in emotional state ( K10 : median ( IQR ) 14.6 ( 13.4–16.0 ) to 12.6 ( 11.5–13.8 ) ) , and quality of life ( EQ5D-Index : median ( IQR ) 0.84 ( 0.8–0.9 ) to 0.92 ( 0.9–1.0 ) ) at 6 weeks . Conclusions This smartphone-based home care CR programme improved post-MI CR uptake , adherence and completion . The home-based CR programme was as effective in improving physiological and psychological health outcomes  as traditional CR . CAP-CR is a viable option towards optimising use of CR services . Trial registration number ANZCTR12609000251224 PURPOSE This study was done to identify effects of a smoking cessation program including telephone counseling and text messaging using stages of change for out patients who have had a myocardial infa rct ion ( MI ) . METHODS This research was a quasi-experimental design with a nonequivalent control group pretest-posttest . The participants were 48 out patients ( experimental group=24 , control group=24 ) recruited from one university hospital . They were r and omly assigned to one of two groups : ( a ) an experimental group with telephone counseling ( once a week ) and text messaging ( five times a week ) using stages of change , and ( b ) a control group with traditional telephone counseling ( once a month ) . Efficacy of the intervention was measured by comparing the two groups on smoking-related variables at 3 weeks and 12 weeks . RESULTS At the 3-week and 12-week measurements , there were significant differences between the experimental and control groups on smoking cessation self-efficacy ( p<.001 ) , nicotine dependence ( p<.001 ) , CO levels ( p<.001 ) , and smoking cessation rates ( p<.001 ) . CONCLUSION The results indicate that the smoking cessation program including telephone counseling and text messaging using stages of change is effective for out patients after a MI . Further attention should be paid to the intensity of the smoking cessation program and periods for long-term follow-up Background In New Zeal and , around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained . Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities . However , on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of re sources and geographical location . Currently most people receive no treatment beyond three months post stroke . The study aims to determine if the Augmented Community Telerehabilitation Intervention ( ACTIV ) results in better physical function for people with stroke than usual care , as measured by the Stroke Impact Scale , physical subcomponent . Methods / design This study will use a multi-site , two-arm , assessor blinded , parallel r and omised controlled trial design . People will be eligible if they have had their first ever stroke , are over 20 and have some physical impairment in either arm or leg , or both . Following discharge from formal physiotherapy services ( inpatient , outpatient or community ) , participants will be r and omised into ACTIV or usual care . ACTIV uses readily available technology , telephone and mobile phones , combined with face-to-face visits from a physiotherapist over a six-month period , to help people with stroke resume activities they enjoyed before the stroke . The impact of stroke on physical function and quality of life will be assessed , measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options . These outcomes will be collected at baseline , six months and 12 months . In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study . Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may contribute to a functional decline following discharge from formal rehabilitation . Best practice guidelines recommend a prolonged period of rehabilitation , however this is expensive and therefore not undertaken in most publicly funded centres . An effective , cost-effective , and preference-sensitive therapy using basic technology to assist programme delivery may improve patient autonomy as they leave formal rehabilitation and return home . Trial registration The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Background Cardiovascular disease ( CVD ) is the leading cause of early death worldwide , responsible for an estimated 29 % of all global deaths . Reducing salt intake lowers blood pressure and risk of secondary cardiac events . However , identifying low salt foods can be challenging . SaltSwitch is a simple smartphone application ( app ) that enables shoppers to scan the barcode of packaged foods and receive an immediate , interpretive , traffic light nutrition label on the screen , along with suggestions for healthier lower-salt alternatives . A growing body of evidence suggests mobile technologies can support healthy behaviour change . However , robust evidence for the impact of smartphone interventions is lacking . This manuscript outlines the rationale and methods for a r and omized controlled trial design ed to determine the effectiveness of SaltSwitch in supporting people with CVD to make lower-salt food choices . Design / Methods A 6-week , two-arm , parallel , r and omized controlled trial is being undertaken in New Zeal and ( 2 weeks baseline and 4 weeks intervention ) . Three hundred adults aged 40 years and older with CVD and their main household shoppers are recruited from research lists , cardiac rehabilitation clinics , and communities in Auckl and . Participants are r and omized to receive either the SaltSwitch smartphone app or no intervention ( control ) . R and omisation is stratified by ethnicity and age . The primary outcome is the salt content of household food purchases . Secondary outcomes are the saturated fat and energy content of household food purchases , household food expenditure , use and acceptability of the SaltSwitch app by shoppers , and urinary sodium and blood pressure of participants with CVD . Ambulatory blood pressure and potential longer-term impact ( 12 weeks ) of SaltSwitch will be assessed in sub- studies ( n ~ 40 and n ~ 20 , respectively ) . Household purchases of salt and other nutrients will be assessed using till receipt data electronically linked with br and ed food composition data . Discussion The results of the SaltSwitch trial will determine the effectiveness , use and acceptability of a smartphone application to support lower salt food choices and secondary prevention of CVD.Trial registration ACTRN12614000206628 . Registered 30 March 2014 Background Exercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease . Despite the benefits associated with regular exercise , adherence with supervised exercise-based cardiac rehabilitation remains low . Increasingly powerful mobile technologies , such as smartphones and wireless physiological sensors , may extend the capability of exercise-based cardiac rehabilitation by enabling real-time exercise monitoring for those with coronary heart disease . This study compares the effectiveness of technology-assisted , home-based , remote monitored exercise-based cardiac rehabilitation ( REMOTE ) to st and ard supervised exercise-based cardiac rehabilitation in New Zeal and adults with a diagnosis of coronary heart disease . Methods / Design A two-arm , parallel , non-inferiority , r and omised controlled trial will be conducted at two sites in New Zeal and . One hundred and sixty two participants will be r and omised at a 1:1 ratio to receive a 12-week program of technology-assisted , home-based , remote monitored exercise-based cardiac rehabilitation ( intervention ) , or an 8 - 12 program of st and ard supervised exercise-based cardiac rehabilitation (control).The primary outcome is post-treatment maximal oxygen uptake ( V̇O2max ) . Secondary outcomes include cardiovascular risk factors ( blood lipid and glucose concentrations , blood pressure , anthropometry ) , self-efficacy , intentions and motivation to be active , objective ly measured physical activity , self-reported leisure time exercise and health-related quality of life . Cost information will also be collected to compare the two modes of delivery . All outcomes are assessed at baseline , post-treatment , and 6 months , except for V̇O2max , blood lipid and glucose concentrations , which are assessed at baseline and post-treatment only . Discussion This novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach . If the REMOTE program proves to be as effective as traditional cardiac rehabilitation , it has potential to augment current practice by increasing access for those who can not utilise existing services . Trial registration Australian New Zeal and Clinical Trials Registry Study ID number : ACTRN12614000843651 . Registered 7 August Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : Background : Medication non-adherence leads to a vast range of negative outcomes in patients with coronary artery disease . An automated web-based system managing short message service ( SMS ) reminders is a telemedicine approach to optimise adherence among patients who frequently forget to take their medications or miss the timing . Aim : This paper sought to investigate the effect of automated SMS-based reminders on medication adherence in patients after hospital discharge following acute coronary syndrome ( ACS ) . Methods : An interventional study was conducted at a tertiary teaching hospital in Malaysia . A total of 62 patients with ACS were equally r and omised to receive either automated SMS reminders before every intake of cardiac medications or only usual care within eight weeks after discharge . The primary outcome was adherence to cardiac medications . Secondary outcomes were the heart functional status , and ACS-related hospital readmission and death rates . Results : There was a higher medication adherence level in the intervention group rather than the usual care group , ( χ2 (2)=18.614 , p<0.001 ) . The risk of being low adherent among the control group was 4.09 times greater than the intervention group ( relative risk = 4.09 , 95 % confidence interval ( CI ) 1.82–9.18 ) . A meaningful difference was found in heart functional status between the two study groups with better results among patients who received SMS reminders , ( χ2 ( 1 ) = 16.957 , p<0.001 ) . Conclusion : An automated SMS-based reminder system can potentially enhance medication adherence in ACS patients during the early post-discharge period BACKGROUND Although physical activity has significant health benefits in the treatment of patients with coronary heart disease , patients often do not follow prescribed physical activity recommendations . Behavioural strategies have been shown to be efficacious in increasing physical activity among those patients with coronary heart disease who are attending structured cardiac rehabilitation programmes . Research has also shown that tailoring consultation according to patients ' needs and sending motivational reminders are successful ways of motivating patients to be physically active . However , there is a lack of evidence for the efficacy of behavioural interventions based on individualised consultation in promoting physical activity among those patients with coronary heart disease who are not attending structured physical activity programmes . OBJECTIVE This paper outlines the study protocol for a trial which is currently underway , to examine the effect of a behavioural change intervention delivered through individualised consultation calls and motivational reminder text messages on the level of physical activity among patients with coronary heart disease . SETTING Two large hospitals in Jordan . PARTICIPANTS Eligible patients aged between 18 and 70 years , who are clinical ly stable , are able to perform physical activity and who have access to a mobile telephone have been r and omly allocated to control or intervention group . DESIGN AND METHODS Two-group r and omised controlled trial . Behavioural intervention will be compared with usual care in increasing  physical activity levels among patients with coronary heart disease . The control group ( n=85 ) will receive advice from their doctors about physical activity as they would in usual practice . The intervention group ( n=71 ) will receive the same advice , but will also receive behavioural change intervention ( goal - setting , feed-back , self-monitoring ) that will be delivered over a period of six months . Intervention will be delivered through individually tailored face-to-face and telephone consultations , supported by motivational SMS text messages to encourage and remind patients to attain these goals . The participants and the research er delivering the intervention are not blinded to group assignment . RESULTS Recruitment started in February 2012 and preliminary findings are expected in November 2012 . CONCLUSION It is hypothesised that behavioural intervention delivered through tailored individualised consultation supported by motivational SMS text message reminders will help CHD patients to increase their level of PA . TRIAL REGISTRATION The study is registered as a clinical trial at IS RCT N register ( IS RCT N48570595 ) Background — Although preventive drug therapy is a priority after acute coronary syndrome , less is known about adherence to behavioral recommendations . The aim of this study was to examine the influence of adherence to behavioral recommendations in the short term on risk of cardiovascular events . Methods and Results — The study population included 18 809 patients from 41 countries enrolled in the Organization to Assess Strategies in Acute Ischemic Syndromes ( OASIS ) 5 r and omized clinical trial . At the 30-day follow-up , patients reported adherence to diet , physical activity , and smoking cessation . Cardiovascular events ( myocardial infa rct ion , stroke , cardiovascular death ) and all-cause mortality were documented to 6 months . About one third of smokers persisted in smoking . Adherence to neither diet nor exercise recommendations was reported by 28.5 % , adherence to either diet or exercise by 41.6 % , and adherence to both by 29.9 % . In contrast , 96.1 % of subjects reported antiplatelet use , 78.9 % reported statin use , and 72.4 % reported angiotensin-converting enzyme/angiotensin receptor blocker use . Quitting smoking was associated with a decreased risk of myocardial infa rct ion compared with persistent smoking ( odds ratio , 0.57 ; 95 % confidence interval , 0.36 to 0.89 ) . Diet and exercise adherence was associated with a decreased risk of myocardial infa rct ion compared with nonadherence ( odds ratio , 0.52 ; 95 % confidence interval , 0.4 to 0.69 ) . Patients who reported persistent smoking and nonadherence to diet and exercise had a 3.8-fold ( 95 % confidence interval , 2.5 to 5.9 ) increased risk of myocardial infa rct ion/stroke/death compared with never smokers who modified diet and exercise . Conclusions — Adherence to behavioral advice ( diet , exercise , and smoking cessation ) after acute coronary syndrome was associated with a substantially lower risk of recurrent cardiovascular events . These findings suggest that behavioral modification should be given priority similar to other preventive medications immediately after acute coronary syndrome . Clinical Trial Registration Information— URL : http:// clinical trials.gov/ct2/show/NCT00139815 . Unique identifier : NCT00139815 Background An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits , including decreased mortality . Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation . One component related to the efficacy of these interventions is tailoring of the content to the individual . Objective Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay . We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version . Methods The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone . The participants were r and omized in monthly clusters to a tailored or nontailored ( control ) intervention group . All participants had access to a website with information regarding cardiac rehabilitation , an online discussion forum , and an online activity calendar . Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages . The main outcome was self-reported level of physical activity , which was obtained using an online international physical activity question naire at baseline , at discharge , and at 1 month and 3 months after discharge from the cardiac rehabilitation program . Results Included in the study were 69 participants . One month after discharge , the tailored intervention group ( n=10 ) had a higher median level of overall physical activity ( median 2737.5 , IQR 4200.2 ) than the control group ( n=14 , median 1650.0 , IQR 2443.5 ) , but the difference was not significant ( Kolmogorov-Smirnov Z=0.823 , P=.38 , r=.17 ) . At 3 months after discharge , the tailored intervention group ( n=7 ) had a significantly higher median level of overall physical activity ( median 5613.0 , IQR 2828.0 ) than the control group ( n=12 , median 1356.0 , IQR 2937.0 ; Kolmogorov-Smirnov Z=1.397 , P=.02 , r=.33 ) . The median adherence was 45.0 ( 95 % CI 0.0 - 169.8 ) days for the tailored group and 111.0 ( 95 % CI 45.1 - 176.9 ) days for the control group ; however , the difference was not significant ( P=.39 ) . There were no statistically significant differences between the 2 groups in stage of change , self-efficacy , social support , perceived tailoring , anxiety , or depression . Conclusions Because of the small sample size and the high attrition rate at the follow-up visits , we can not make conclusions regarding the efficacy of our approach , but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention . Trial Registration Clinical Trials.gov : NCT01223170 ; http:// clinical trials.gov/show/NCT01223170 ( Archived by WebCite at http://www.webcitation.org/6Nch4ldcL ) OBJECTIVE Pharmacologic treatment for secondary prevention of coronary heart disease ( CHD ) is critical to prevent adverse clinical outcomes . In a r and omized controlled trial , we compared antiplatelet and statin adherence among patients with CHD who received : ( 1 ) text messages ( TM ) for medication reminders and education , ( 2 ) educational TM only , or ( 3 ) No TM .  METHODS A mobile health intervention delivered customized TM for 30 days . We assessed and analyzed medication adherence with electronic monitoring devices [ Medication Event Monitoring System ( MEMS ) ] by one-way ANOVA and Welch tests , two-way TM response rates by t-tests , and self-reported adherence ( Morisky Medication Adherence Scale ) by Repeated Measures ANOVA . RESULTS Among 90 patients ( 76 % male , mean age 59.2 years ) , MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken ( p=0.02 ) , percentage number of doses taken ( p=0.01 ) , and percentage of prescribed doses taken on schedule ( p=0.01 ) .  TM response rates were higher for antiplatelets than statins ( p=0.005 ) . Self-reported adherence revealed no significant differences among groups . CONCLUSION TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses . PRACTICE IMPLICATION S Feasibility and high satisfaction were established . Mobile health interventions show promise in promoting medication adherence PURPOSE : Efficient ways are needed to implement the secondary prevention ( SP ) of coronary heart disease . Because few studies have investigated Web-based SP programs , our aim was to determine the usefulness of a new Web-based telemonitoring system , connecting patients provided with self-measurement devices and care managers via mobile phone text messages , as a tool for SP . METHODS : A single-blind , r and omized controlled , clinical trial of 203 acute coronary syndrome ( ACS ) survivors , was conducted at a hospital in Madrid , Spain . All patients received lifestyle counseling and usual-care treatment . Patients in the telemonitoring group ( TMG ) sent , through mobile phones , weight , heart rate , and blood pressure ( BP ) weekly , and capillary plasma lipid profile and glucose monthly . A cardiologist accessed these data through a Web interface and sent recommendations via short message service . Main outcome measures were BP , body mass index ( BMI ) , smoking status , low-density lipoprotein-cholesterol ( LDL-c ) , and glycated hemoglobin A1c ( HbA1c ) . RESULTS : At 12-month followup , TMG patients were more likely ( RR = 1.4 ; 95 % CI = 1.1−1.7 ) to experience improvement in cardiovascular risk factors profile than control patients ( 69.6 % vs 50.5 % , P = .010 ) . More TMG patients achieved treatment goals for BP ( 62.1 % vs 42.9 % , P = .012 ) and HbA1c ( 86.4 % vs 54.2 % , P = .018 ) , with no differences in smoking cessation or LDL-c . Body mass index was significantly lower in TMG ( −0.77 kg/m2 vs + 0.29 kg/m2 , P = .005 ) . CONCLUSIONS : A telemonitoring program , via mobile phone messages , appears to be useful for improving the risk profile in ACS survivors and can be an effective tool for secondary prevention , especially for overweight patients Objective : Medication adherence is a complex behavior that is influenced by numerous factors . Applying self-efficacy theory , the primary aim of this r and omized controlled trial was to compare medication self-efficacy among patients with coronary heart disease who received : ( a ) text messages ( TMs ) for medication reminders and education , ( b ) TMs for education , or ( c ) no TMs .  The second aim was to identify the personal ( sociodemographic and clinical characteristics ) and psychosocial factors that were associated with and predicted medication adherence . Methods : Customized TMs were delivered over 30 days . Repeated measures analysis of variance was used to analyze medication self-efficacy . A multiple regression analysis was performed at baseline and follow-up to determine variables that were associated with and predicted self-reported medication adherence . Results : Among 90 subjects with mean age 59.2 years ( st and ard deviation ( SD ) 9.4 , range 35–83 ) , total scores for medication self-efficacy improved over 30 days ; however , there was no significant difference in this improvement as a function of the different treatment groups ( p=0.64 ) . Controlling for other variables in the model ( age , education , depression , and social support ) , less depression ( p=0.004 ) and higher social support ( p=0.02 ) positively predicted higher medication adherence in the final model . Conclusions : TM medication reminders and /or health education did not improve medication self-efficacy . Further theory testing of current and future models and interventions are required to underst and variables related to self-efficacy and medication adherence . Addressing psychosocial factors such as depression and social support should be a priority to improve medication adherence among patients with coronary heart disease
Background Mobile wireless devices ( mHealth ) have been used to deliver cardiovascular disease self-management interventions to educate and support patients in making healthy lifestyle changes .
This systematic review aim ed to determine the effectiveness of mHealth interventions on behavioural lifestyle changes and medication adherence for cardiovascular disease self-management .