Table 3 Primary endpoints based on part 2
Outcome | Assessment procedure | Assessment timepoints | Corresponding study objectives |
|---|---|---|---|
Feasibility and suitability of trial procedures | Response rates, trial uptake, and number of dropouts | Throughout data collection period | Part 2: objectives 1, 2, and 3 |
Feasibility of recruitment | Appropriateness of eligibility criteria: number of participants referred or interested who meet the eligibility criteria | Throughout data collection period | Part 2: objectives 1, 2, and 3 |
Recruitment rate: number of eligible patients who consent and decline to participate (including reasons for nonparticipation) | |||
Retention rates: number of participants who consent and remain in the trial by 6-month follow-up | |||
Appropriateness of self-report clinical and health economics measures | Completion rates, rate of return, data completeness (the number of missing data), number of reminders and requests for extra support to complete measures, and content of contacts between service providers/researchers and patient participants | Baseline, 3-month and 6-month follow-up | Part 2: objectives 1 and 2 |
Patient preference for different versions/formats of the outcome data collection tools | Number completed via paper/online/telephone, the number and types of reminders required to complete measures, data completeness, the number of participants who complete 3-month and 6-month follow-up measures | Baseline, 3-month and 6-month follow-up | Part 2: objectives 1 and 2 |
Fidelity of the intervention | Accuracy and quality of intervention delivery: intervention record forms, audio/video recordings, and case notes of intervention sessions | Throughout data collection period | Part 2: objectives 3, 4, 5, 6, and 7 |
Contextual and process issues related to intervention delivery: clinical notes, intervention record forms, audio/video recordings of intervention sessions, and monthly supervision sessions with the NEuRoMS therapists and part 3 interviews | |||
Documentation of usual care and contamination | Record of any cognitive support provided by the clinical team: review of clinical notes, resource-use questionnaires, and through monthly teleconferences/videoconferences with clinicians, monthly supervision sessions with the NEuRoMS therapists, and the part 3 interviews | Throughout data collection period | Part 2: objectives 8 and 9 |
Record of potential sources of contamination in the control group: Review of clinical notes, resource-use questionnaire, and through monthly supervision and mentoring sessions with the NEuRoMS therapists and the Part 3 interviews |