Skip to main content

Table 5 Criteria for progression of pilot feasibility study to a definitive trial

From: Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study

Feasibility outcome Progression criterion
Recruitment
 1. Proportion of eligible nursing homes which agree to participate in study ≥ 70% of eligible nursing homes agree to take part in the study, proceed; 30–70% agree to take part, modify protocol; < 30% agree to participate, do not proceed.
 2. Adequate participant recruitment rate Recruitment rate in each nursing homes of > 80% of required (n = 16), proceed; 60–80% of required (n = 12–15), modify protocol; < 60% of required (n < 12), do not proceed.
 3. Average time for recruitment of nursing homes and participants Nursing homes
Measured from initial contact to decision to participate:
If < 4 weeks, proceed; if 4–8 weeks, modify protocol; if > 8 weeks, do not proceed
Participants
Measured from initial contact to consent obtained:
If < 3 weeks, proceed; if 3–5 weeks, modify protocol; if > 5 weeks, do not proceed
Outcome assessment
 4. Adequate retention rate of nursing homes and participants at 3-month and 12-month follow-up Nursing homes
Both nursing homes are required to complete the 12-month follow-up;
Participants
Measured using the following scale in both the intervention and control group:
At 3 months: if > 80% retained, proceed; if 60%–80% retained, modify protocol; if < 60% retained, do not proceed
At 12 months: if > 70% retained, proceed; if 40%–70% retained, modify protocol; if < 40% retained, do not proceed
Protocol adherence
 5. Adequate adherence rates of participants to the intervention > 80% of the participants in the intervention arm complete 75% of their physical activity programme, proceed; 60–80% of participants complete 75% of the physical activity programme, modify protocol; < 60% of participants complete 75% of physical activity programme.