Title: Journeying through dementia; randomised controlled trial of clinical and cost effectiveness
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: In 2009 the UK government mandated the establishment of memory services in each health locality so that people experiencing symptoms of dementia can access expert diagnosis and help. The drive for earlier and better diagnosis continues, and was emphasised in the Prime Ministers Challenge on dementia. However the availability of services following early diagnosis has not kept pace. Some memory services provide assistance following diagnosis but others offer little more than medication. One of the reasons is that there is no history of early intervention; until recently many people were not diagnosed until the later stages of the condition. Another reason is that it was believed that nothing could be achieved with the individual once diagnosis had been made. This view is now changing due to the availability of medication to alleviate symptoms combined with a growing societal movement to raise awareness and promote living well with dementia. Additionally there is a recent realisation that people with the condition can be helped to be independent for longer. Nevertheless, extent of unmet need among those who receive an early diagnosis is significant. This project involves examining the effectiveness of an intervention called Journeying through Dementia for those who are in the early stages of dementia. The content of Journeying through Dementia was identified through consultation with people with dementia. It was developed to assist people to self-manage their condition and continue to participate in life. In addition to being informed through consultation with people living with dementia, it was also informed by research evidence. It has been designed for delivery through memory services but if it does prove effective through this research it might be successfully used in other settings such as the voluntary sector. It involves working with people with dementia in a small group of around eight-twelve people for two hours for 12 weeks. Each participant is introduced to one of the facilitators before the group commences and also receive three further individual sessions during the course of the intervention. Facilitators are staff experienced with working with people with dementia and have received specialist training to deliver the intervention and receive weekly supervision. A person with dementia can if they would like bring along a family member or friend to the individual sessions and week 1, 6 and 12 of the group sessions. Through two preparatory studies and a feasibility study we have already explored whether Journeying through Dementia is what people want and whether it can be delivered; 30 people living with dementia have been involved in preparatory studies. Our work to date demonstrates that Journeying through Dementia can meet the needs of people with early dementia; a group established in Sheffield became self-sustaining. We are now ready to undertake a robust evaluation to determine the extent and nature of benefit that the person with dementia and their family member/friend might derive. We are planning to recruit about 486 people with dementia in 10 areas in North and Central England. This will require approximately half of those who volunteer to be involved not receiving the intervention so that we are able to make a comparison. We are particularly interested in whether those who participate experience a better quality of life.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL