Skip to main content

Table 2 Feasibility data and method of measurement

From: Behavioural activation written self-help to improve mood, wellbeing and quality of life in people with dementia supported by informal carers (PROMOTE): a study protocol for a single-arm feasibility study

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 6 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

 

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