Fidelity/feasibility/acceptability | Method of data collection | Aims to explore | Method of analysis/data to be presented | Participants | Time |
---|---|---|---|---|---|
Fidelity to trial methodology (PC2) | Audio recordings of NERS initial consultations with participants | The accuracy with which recruitment and consent processes were followed. | A summary score of adherence to the processes (range 0–4) will be calculated for each recording and presented overall and by area. | Two participants per exercise professional | T0 (during NERS initial consultation) |
Feasibility of implementing the intervention and trial methodology within routine NERS practice | Telephone interviews with NERS staff | Barriers/facilitators, fit with local context, any adverse effects on usual NERS delivery, differences across settings, additional infrastructure or resources required for a full trial. | Thematic analysis. | Two exercise professionals per area | After receipt of the intervention at 4Â weeks and at T2 |
Acceptability of the trial methodology (PC4) | Telephone interviews with NERS staff and intervention participants | Understandings and acceptability of recruitment and randomisation processes. | Thematic analysis. | Two exercise professionals per area, 20 intervention participants | After receipt of the intervention at 4Â weeks and at T2 |
Self-report questions on study questionnaire | Percentages of participants reporting acceptability of the randomisation process. | All participants | T1 | ||
Acceptability of the intervention (PC3) | Telephone interviews with professionals and participants patients | Perceived acceptability of intervention components, barriers and facilitators in using the devices. | Thematic analysis. | Two exercise professionals per area, 20 intervention participants | After receipt of the intervention at 4Â weeks and at T2 |
Self-report questions on study questionnaire | Frequency of use, ease of use, likelihood of future use. | Percentages of participants reporting that the intervention was easy to use, that they used it, and would do so in the future. | All intervention participants | T1 and T2 | |
Feasibility of collecting objective data on physical activity at long-term follow-up | ActiGraph accelerometers | The feasibility of obtaining measures of physical activity over a 7Â day period. | A linear regression model controlling for age, gender, baseline self-reported physical activity and randomisation group will be fitted. Results will be expressed using regression coefficients, 95% confidence intervals, and standardised effect sizes. | 100 participants | 16Â months post-randomisation |
Contamination (PC5) | Self-report questions on study questionnaire on awareness of and exposure to intervention components | Assessment of contamination between trial arms. | Percentages of participants in intervention and control arms reporting exposure to the intervention will be presented alongside 95% confidence intervals. | All participants | T1 and T2 |