Design and participants
chronic diseases, hypertension, hypertensive
PRIMARY HYPERTENSION, CHRONIC DISEASES, MAY, HYPERTENSION, COMPLICATIONS
The present randomized parallel-controlled trial study was registered on the Iranian Registry of Clinical Trials Website (IRCT), ID: IRCT20141222020401N6, on 8/5/2019. The present study was conducted on ninety eligible hypertensive patients referring to Yasuj Shahid Dastgheib Health Center, Iran, from May 2019 to October 2019. A total of 41 participants were calculated as the sample size for each group considering α = 0.05, zAccording to the researcher's guess and dropout prediction in interventional studies, 10% attrition rate was considered. Therefore, a total of 90 participants, each group comprising 45 patients, participated in the present study.Patients with hypertension who had health records in Shahid Dasghib Health Center were selected as research participants. The telephone numbers of the patients were contacted, and the objectives of the research were explained to them. Those who wanted to participate in this research were invited to attend the health center and were assessed in terms of inclusion and exclusion criteria. Then, written informed consent was signed by eligible patients. The written informed consent included familiarizing with the research, goals, and interventions, stating the advantages and disadvantages of participating in the research and compensating for the disadvantages, maintaining the confidentiality, and the right to withdraw from the study.They were selected through convenience sampling. However, they were randomly assigned to one of the two groups of intervention (n = 45) and control (n = 45), using the randomized block allocation method as follows: Initially, by multiplying the number of study groups by two (an intervention group and a control group), four people were assigned to each group. At that point, twenty-four blocks were calculated using the factorial rule (24 = 1 × 2 × 3 × 4 = !4). The members of each block were marked with the letters A, B, C, D. Subsequently, letters A and B were assigned to the control group, and letters C and D were randomly assigned to the intervention group. A total of twenty-four blocks with possible layouts were identified. Allocation was done by randomly selecting each block by an individual outside the research team.Furthermore, the samples were selected based on the sequence of blocks and the time priority of the participants' entry. Randomization continued until 45 patients were in the intervention group and 45 in the control group. Blinding was not done in the present study.Inclusion criteria consisted of a definitive diagnosis of primary hypertension, stage 1 or 2 hypertension, age range of 18–65 years, at least six months of hypertension, informed consent to participate in the study, and lifestyle score of ≤ 105. Patients’ unwillingness to participate in the study, not having other chronic diseases or severe complications following hypertension and lack of inclusion criteria were considered exclusion criteria.