Variables | Indicators |
---|---|
Intervention feasibility | |
1- The possibility to deliver the intervention as planned 2- Participants adhering to the intervention | - Provision of ≥80% of planned components of each in-presence session and of the overall intervention [59]. |
- Session duration (sessions 1 to 6: 15 min). | |
- Challenges faced during session delivery. | |
- Attendance to ≥80% of sessions by participants [59]. | |
- Involvement in intervention activities and implementation of recommended self-management ≥80% behaviors by participants [59]. | |
Research methods feasibility | |
1- Adequacy of the sampling pool and recruitment time 2- Ease of screening 3- The possibility of applying randomization procedures as planned 4- Attrition rate in experimental and control groups 5- Ease of data collection procedures | - Obtaining consent from ≥80% of patients approached to participate in the study. |
- Percentage of eligible patients who were included in the study. - Patient’s reasons for refusal to participate in the study. | |
- Difficulties in obtaining patients’ consent. | |
- Recruiting study sample (i.e., 50 participants) in ≤9 months [31]. | |
- The time required to screen participants relative to recruitment. | |
- The time required to obtain consent and baseline data relative to recruitment. | |
- Eligibility criteria not limiting the pool of participants by ≥50% [32]. | |
- Reasons for ineligibility. | |
- Difficulties when applying the randomization procedures. | |
- Patient acceptance to randomization, either to the treatment or control group ≥80% of the time [32]. | |
- Attrition rate in experimental and control groups, i.e., ≤ 20% [60]. | |
- Percentage of questionnaires completed in full. | |
- Pattern and rates of non-answered questions at each time measure. | |
- Mean time required to complete the outcome questionnaires. | |
- Mean time period between expected dates for questionnaire completion and actual completion. | |
- Recall rates (telephone calls or emails) for questionnaire completion. |