A structured programme of group and individual sessions is being tested to help people in the early stages of dementia rebuild confidence and daily living skills. Dementia often strips away a person’s ability to manage everyday tasks and maintain social connections, yet few interventions focus on helping people actively re-engage with their lives rather than simply managing symptoms. This trial compares the Journeying through Dementia programme against usual care, measuring whether it improves quality of life, independence, and emotional wellbeing. If the programme proves effective, it could offer a practical, non-drug option that helps people with dementia stay engaged in their communities for longer. The trial also includes a cost-effectiveness analysis, so health services would know whether the programme delivers value for money. For the family members and friends who often provide unpaid care, the study tracks whether the intervention reduces their own stress and improves their sense of competence.
View original technical description
DESIGN: A randomised controlled trial of Journeying through Dementia, with an internal pilot trial with a defined stop/ go criteria. SETTING: Community venues for group delivery; participants’ homes/ community for individual sessions. POPULATION: People with dementia e.g. Alzheimer’s disease, vascular dementia/ mixed Alzheimer’s/ vascular dementia. People with dementia can also involve a family member or friend if they would like (participating supporters).However this is optional. INCLUSION CRITERIA: (i) in the early stages of dementia (MMSE score 18 and over); [ii) can make informed decisions; (iii) community living. EXCLUSION CRITERIA (i) in the moderate/later stages of dementia; (ii) lacks mental capacity; (iii) in residential/nursing care. HEALTH TECHNOLOGIES BEING ASSESSED: A manualised intervention which involves 12 group and 4 individual facilitated sessions to promote self-management and re-engagement with activities. OUTCOME ASSESSMENT: People with dementia will have outcomes measures taken at baseline and 8 months post randomisation. These include: Primary: DEMQOL- Measures self-reported health related quality of life in dementia. Secondary: improving skills in instrumental activities of daily living (IADLs), self-efficacy (General Self-Efficacy Scale), building relationships and sense of connectedness (Self-Management Ability Scale and Diner’s Flourishing Scale), depressive symptomology (PHQ-9), anxiety symptoms (GAD-7), health related quality of life (EQ-5D-5L) and resource use (Health and Social Care Resource Use Questionnaire). In addition some measures will be repeated at 12 months post baseline: DEMQOL, EQ-5D-EL and Health and Social Care Resource Use Questionnaire. Participating supporters will be asked to complete at baseline and 8 months post randomisation the PHQ-9, Sense of Competency in Caregiving Questionnaire and the EQ-5D-5L. SAMPLE SIZE: Assuming a standard deviation of 11 points for DEMQOL and that a mean difference of 4 or more points is clinically and practically important. To have an 90% power of detecting this mean difference (a standardised effect size of 0.29) as statistically significant at the 5% (two-sided) level; allowing for clustering (average cluster size of 8 per group and an intra-cluster correlation of 0.03) and 20% loss to follow-up. We will recruit and randomise 243 participants per arm (N=486). ANALYSIS: Analyses will compare the two arms of the trial on an as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants with dementia at 8 months between the two arms using a marginal general linear model (GLM) with robust standard errors, to allow for clustering by group. Secondary outcomes between the intervention and control groups will be compared at 8 months and 12 months post randomisation. A cost-effectiveness analysis will be undertaken of the incremental cost per Quality Adjusted Life Years (QALYs) of the JtD intervention compared with treatment as usual. ADDITIONAL SUB STUDIES: Embedded qualitative and fidelity sub-studies will be conducted to explore the underlying mechanisms of the intervention. TIMETABLE/ RECRUITMENT: 42 month project. Recruitment will start in Month 10 and sites will recruit for 10 months. EXPERTISE: Clinical academics with dementia expertise, methodological experts, registered Trials Unit, PPI.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know