Dementia Mental and Behavioural Disorders
Conditions
Interventions
This research is a randomised feasibility study of trial processes and intervention implementation with an embedded qualitative element. The feasibility study will test processes and gather informatio
complete qualitative and T2 quant data collection. Months 23–27 analysis, writing, knowledge exchange.
Phase 1:
We will host three workshops with a range of stakeholders, two for the manual developme
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 04/06/2026: 1. Adults of any age 2. Has received a diagnosis of dementia of any type from a medical professional or other practitioner empowered to assess this (For recruitment through NHS) 3. Self- identifies as having a dementia diagnosis (For recruitment through community organisations) 4. Living in a community local to the proposed Good Life course (bounded by memory service or community organisation recruiting) 5. With mental capacity to give informed consent 6. Willing and able to attend a 6-week in person group intervention For dedicated South Asian Group 7. Self-identify as a member of a South Asian Community _____ Previous key inclusion criteria: Adults of any age: 1. Has received a diagnosis of dementia of any type from a medical professional or other practitioner empowered to assess this (for recruitment through the NHS) 2. Self- identifies as having a dementia diagnosis (for recruitment through community organisations) 3. Diagnosed within the previous 12 months (from consent to contact) 4. Living in a community local to the proposed Good Life course (bounded by memory service or community organisation recruiting) 5. With mental capacity to give informed consent (at baseline) 6. Willing and able to attend a 6-week in-person group intervention For the dedicated South Asian Group: Self-identify as a member of a South Asian Community
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 04/06/2026: 1. People with dementia 2. People without the mental capacity to give informed consent at baseline 3. People with dementia living in care homes 4. People attending or booked to attend similar group-based interventions (such as LivDem) other than those that form part of usual care such as CST. 5. If the trajectory of the person's health (based on clinical judgement) suggests that they will be unable to participate to the end of the planned data collection (six months post course attendance) _____ Previous key exclusion criteria: 1. People without the mental capacity to give informed consent at baseline 2. People with dementia living in care homes 3. People diagnosed more than 12 months ago (from consent to contact) 4. People attending or booked to attend similar group-based interventions (such as LivDem) other than those that form part of usual care such as CST 5. If the trajectory of the person's health (based on clinical judgement) suggests that they will be unable to participate to the end of the planned data collection (6 months post course attendance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Conversion rates (from eligible sample to consent to contact to informed consent) measured using screening log, (study-specific) records and consent records, calculated at the close of recruitment 2. Overall recruitment rates and barriers to recruitment measured using screening logs and consent records (including reasons for declining) completed at a) initial approach and b) after giving consent to contact) 3. The number of people who provided data at each timepoint measured using research data at baseline, 3 and 6 months 4. Retention rates at 3 and 6 month follow ups including loss to follow up measured using research data at 3 and 6 months, and withdrawal records reviewed monthly 5. The proportion of people adhering to the intervention measured using weekly attendance records (for the 6-week intervention period) 6. The acceptability and feasibility of the outcome measures as methods to measure effectiveness of the intervention in a definitive trial measured using research data, at baseline 3 and 6 months. and qualitative interviews and focus groups after 6-month follow-up 7. The acceptability of the trial processes to people with dementia/site staff and delivery partners in different community settings measured using qualitative interviews and focus groups after 6-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Key outcome domains for missing data, and completion rates measured using research data at baseline, 3 and 6 months 2. The views and experiences of delivery partners and peer tutors with regard to intervention implementation, barriers and facilitators measured using qualitative interviews and focus groups after 6-month follow-up 3. Whether manualisation supports consistent delivery across settings, determined using fidelity checks at facilitator supervision sessions and through observation of the delivery of at least one course session in each site, together with qualitative interviews and focus groups after 6-month follow-up The following outcome measures are being tested for feasibility and will not be used to measure outcomes definitively in this trial: 1. Capability wellbeing measured using ICECAP-O at baseline, 3 months, 6 months 2. Living well with dementia measured using My Life Questionnaire at baseline, 3 months, 6 months 3. Health related quality of life measured using EQ-5D-5L at baseline, 3 months, 6 months 4. Depression measured using Geriatric Depression Scale at baseline, 3 months, 6 months 5. Loneliness measured using De Jong Gierveld Loneliness Scale at baseline, 3 months, 6 months 6. Experience ‘in the moment’ measured using Canterbury Wellbeing Scale before and after 6 intervention sessions | — |
Countries
England, United Kingdom
Outcome results
None listed