Adherence and protocol deviations
MINOR
Adherence to the intervention will be assessed based on the percent of subjects who either (a) have refused to wear the wrist-worn activity tracker, (b) have not shown up for the clinic visit at 3 and 6 months, or (c) have not engaged in at least 3 out of 5 planned phone counseling sessions. Descriptive statistics on the percent adherence will be summarized for the intervention group.The following are pre-defined major protocol violations with a direct bearing on the primary outcome: (1) failure to perform the baseline 6MWT in enrolled participants. The baseline 6MWT is conducted after patients’ enrollment (i.e., after obtaining their informed consent) to screen for their eligibility (patients covering more than 450 m in the baseline 6MWT are excluded according to the protocol); (2) failure to randomize enrolled and eligible participants; (3) failure to provide intervention to participants allocated to the intervention group, specifically, not providing them with the pedometer or not encouraging them to increase their daily step count; (4) erroneous provision of the intervention to the control group; (5) failure to complete the assessment of the primary outcome at 6 months.The pre-defined minor protocol violations include but are not limited to (1) enrollment of non-eligible participants; (2) variations in the timing of the intervention or assessments; (3) non-adherence to the intervention as defined above; and (4) non-compliance with data collection procedures.The number (and percentage) of patients with major and minor protocol deviations will be summarized by treatment group with details of the type of deviation provided. The number of patients included in the intention-to-treat analysis data set will be used as the denominator to calculate the percentages. No formal statistical testing will be undertaken.