Table 1.
Progression criteriaa | Measures used | Assessment of whether criteria have been met |
PC1. Feasibility to recruit a sufficient proportion of new NERS patients to participate in the trial, with appropriate retention to 12-month follow-up (T2) | Percentage of eligible patients recruited; Percentage of participants retained at T2; Regression models used to identify predictors of loss to follow-up | If >20% of new patients recruited=proceed (green); if <5%=full-scale trial unlikely to be feasible (red). If 5%-20% (amber) of the trial steering committee (TSC) will consider the feasibility of proceeding to a full-scale trial bearing in mind the data presented, representativeness of the sample, and possible steps to increase recruitment; If >80% retained at T2=proceed (green), if <60%=full-scale trial unlikely to be feasible (red). If 60%-80% (amber) of the TSC will consider the feasibility of proceeding based on available data and possible steps to increase retention |
PC2a. Trial methodology delivered as intended PC2b. Intervention delivered as intended | Summary statistics for intervention fidelity measures overall and by area; Compliance with study invite processes; Compliance with randomization processes | The TSC will consider the data presented and make a judgement about whether the intervention and trial methodology were delivered as intended |
PC3. At least 1 of the 2 intervention components is acceptable to participants | Percentages of participants reporting acceptability of intervention components on self-report questions; Issues regarding acceptability of the intervention components explored in qualitative interviews | The TSC will consider the quantitative and qualitative data and make an overall judgement on whether the intervention is acceptable |
PC4. Recruitment and randomization processes acceptable to >50% of recruited participants | Percentages of participants reporting acceptability of recruitment and randomization processes on patient questionnaires; Exploration of understanding and acceptability of recruitment and randomization processes in qualitative interviews | >50% of recruited participants report agree or strongly agree about the acceptability of recruitment and randomization processes; The TSC will apply discretion in judging whether this criterion has been met or could be addressed to improve acceptability in a full-scale trial |
PC5. <20% of control group exposed to the intervention components | Percentage of participants in intervention and control groups who report that they were provided with an MWKb device or accessed the MWC Web platform | <20% of control participants report they have used an MWK device during the study period; <20% of control participants report that they have accessed MWC during study period |
aPC: progression criteria.
bMWK: MyWellnessKey.