Feasibility outcome | Measurement | Progression criteria to phase II pilot RCT |
---|---|---|
Recruitment | Quantitative data | |
Percentage of people with dementia invited into the study/number of people with dementia in total identified by health professionals | No criteria set | |
Number of health professionals required to assist with recruitment into the study | No criteria set | |
The time taken (up to 6Â months) to recruit up to 50 dyads | No criteria set | |
Number of dyads enrolled into the study per week | 2 dyads per week | |
Percentage of dyads willing to undergo screening/number invited (calculated for GP, PCPD and memory service recruitment) | ≥15 % | |
Percentage of dyads overall meeting the inclusion criteria/number invited | ≥5 % | |
Percentage of dyads overall enrolled in the study/number invited | ≥5 % | |
Qualitative data | ||
Reasons for exclusion reported to the research team during health professional screening (GP, PCPDs, memory service) | No criteria set | |
Reasons for ineligibility | No criteria set | |
Identified barriers to recruitment (reasons for refusal of participation) | No criteria set | |
Attrition | Quantitative data | |
 | Percentage of dyads completing post-treatment (3 month) outcome measures | ≥70 % |
Reasons for dropout | No criteria set | |
Qualitative data | ||
Acceptability interviews with non-attendees and poor attendees (informal carers and people with dementia) | No criteria set | |
Data collection procedures | Quantitative data | Â |
Time taken and number of sessions to administer the screening measures | ≤2 h; ≤2 sessions | |
Time taken and number of sessions to administer the baseline assessment | ≤2 h; ≤2 sessions | |
Time taken and number of sessions to administer the follow-up assessments | ≤2 h; ≤2 sessions | |
Percentage of missing items per questionnaire | ≤10 % | |
Qualitative data | ||
Acceptability interviews with participants concerning acceptability of research procedures | No criteria set | |
Acceptability interviews with PWPs concerning acceptability and feasibility of research procedures | No criteria set | |
Clinician adherence | Adherence to support protocol as determined by therapy tapes | ≥70 % |
Clinical delivery | Quantitative data | |
Time between being allocated to PWP and PWP undertaking the assessment session. | ≤2 weeks | |
Session lengths | No criteria set | |
Number of sessions received per dyad | No criteria set | |
Settings of sessions (e.g., BeMe, community, home) | No criteria set | |
 | Number of missed appointments | No criteria set |
Number of missed outcome measurement items | No criteria set | |
PWP attrition | No criteria set | |
Impact of severity of dementia (MMSE score) informing who can engage in the intervention | No criteria set | |
Qualitative data | ||
Acceptability interviews with participants | No criteria set | |
 | Acceptability interviews with PWPs | No criteria set |