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Table 7 Assessment of feasibility criteria

From: A pilot randomised controlled trial of physical activity facilitation for older adults: feasibility study findings

Criteria for proceeding to a definitive trial

Assessment

Criterion fulfilled?

Evidence

An acceptable proportion of individuals respond to recruitment invitations.

Recruitment records show an initial response rate of > 10% to postal invitation and/or > 25% to primary care practitioner invitation or waiting room recruitment. The three methods will be compared.

Yes

Response to postal invitation was high at 68% overall and 27% of responders interested and self-reporting as eligible for the study.

An acceptable proportion of individuals responding to recruitment invitations are eligible to participate.

Screening records show a screen-failure rate of < 80%.

Yes

The screen-failure rate at clinical screening was 74%.

Attrition from the exploratory pilot trial is low.

Trial records show that the proportion of enrolled participants “lost to follow-up” at 6 months is < 20%, excluding deaths and long-term care or hospitalisation.

Yes

Excluding deaths and formal withdrawals, only one participant was lost to follow-up at 6 months (2%).

PAF intervention attracts high rates of participation from eligible adults.

Trial records indicate that adherence to the intervention is high; ≥ 65% of intervention participants participate in at least one face-to-face and five telephone sessions.

Yes

Adherence was very high; 91% of intervention participants received at least one face-to-face and five telephone sessions.

PAF can engage individuals from a range of socio-economic localities.

Participants are recruited from primary care practices in wards with high deprivation scores and low deprivation scores.

Yes

Practices and participants from a variety of sociodemographic backgrounds were involved in the study.

PAF delivery costs can be recorded in a way that enables cost-effectiveness analysis.

Systems developed in the exploratory trial can be used to monitor the costs of a definitive RCT.

Yes

Collection of data on PAF contact time is feasible and could be employed alongside standard trial methods for monitoring costs.

Methods for measuring primary and secondary outcomes and mediator variables are feasible and acceptable.

Process evaluation findings and completed questionnaires suggest that self-report and objective measures were comprehensible and acceptable to > 80% of participants.

Yes—with modification (PASE questionnaire)

Measurement of outcomes was acceptable and largely feasible. However, the pilot study revealed issues with some self-report instruments and ascertainment of these outcomes would need to be modified in any potential future definitive trial.

The sample size required for an adequately powered trial is achievable.

Measurement variability of the primary outcome, recruitment rates, and expected attrition are consistent with a sample size that can be achieved within a reasonable time.

Yes

Sample size calculations under a range of parameters all suggest a definitive trial is achievable.