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Table 5 Summary of process evaluation methods

From: Protocol for a feasibility randomised controlled trial of the use of Physical ACtivity monitors in an Exercise Referral Setting: the PACERS study

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 4 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 4 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 4 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 7 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

16 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