Table 2 Feasibility outcomes and definitions
Outcomea (n/%) | Definition |
|---|---|
Acceptance (180/72.6%) | a) Participant satisfaction with the intervention and study procedures (165/91.7%) b) Participant recruitment or enrolment rate (10/5.6%) c) Intervention completion (16/8.9%) d) Participant retention (11/6.1%) e) Participant feedback (4/2.2%) f) Intervention usability (2/1.1%) |
Contamination (2/0.8%) | The proportion of participants that deviated from their allocated intervention and partook in the alternative intervention |
Complianceb (131/52.8%) | a) Participant attendance of any intervention sessions or simply adherence to assigned intervention (27/20.1%) b) The number of sessions attended and engagement with the intervention (110/82.1%) |
Data completion (9/5%) | The proportion of data expected to be collected which was not |
Enrolment (106/42.7%) | a) The proportion of eligible participants who consented to join the study (95/90.5%) b) The proportion of participants which were recruited and randomized (9/8.5%) c) The proportion of participants recruited, consented and were randomized (2/1.9%) |
Feedback (90/36.3%) | What participants and study staff thought of the intervention, study procedures and their time in the trial |
Fidelity (37/14.9%) | The ability of the trialists to adhere to study protocol |
Randomization (11/4.4%) | The ability to successfully randomly allocate participants to the different arms in a trial |
Retention (135/54.4%) | The proportion of participants which remained in the study till the primary endpoint (either end of the intervention or a set follow-up period) |
Resources (16/6.5%) | An evaluation of the resources required to conduct the study |
Timeliness of intervention (2/0.8%) | Assessment of the ability to administer the intervention in the prespecified time |
Other (34/13.7%) | a) Implementation—the ability to deliver the intervention to participants (17/65.38%) b) Initiation—the proportion of eligible participants which were recruited, consented to join the study and actually began using or were administered the intervention (6/23.07%) c) Consent rate—the proportion of eligible patients which consented to joining the study (1/3.8%) |