REMCARE: reminiscence groups for people with dementia and their family caregivers - effectiveness and cost-effectiveness pragmatic multicentre randomised trial.

OBJECTIVES The aim of the REMiniscence groups for people with dementia and their family CAREgivers (REMCARE) study was to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family caregivers as compared with usual care. DESIGN A multicentre, pragmatic randomised controlled trial with two parallel arms - an intervention group and a usual-care control group - was carried out. A restricted dynamic method of randomisation was used with an overall allocation ratio of 1 : 1, restricted to ensure intervention groups of a viable size. Assessments, blind to treatment allocation, were carried out at baseline, 3 months and 10 months (primary end point). SETTING Most participants were recruited through NHS Memory Clinics and Community Mental Health Teams for older people. Assessments were usually carried out in the person's home, and treatment groups were held in a variety of community settings. PARTICIPANTS A total of 488 individuals (mean age 77.5 years) with mild to moderate dementia (meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria), who were initially living in the community, and who had a relative or other caregiver maintaining regular contact, who could act as an informant and was willing and able to participate in the intervention, were recruited to the study. Most carers were spouses (71%). A total of 350 dyads completed the study. INTERVENTIONS The intervention consisted of joint reminiscence groups held weekly for 12 consecutive weeks, followed by monthly maintenance sessions for a further 7 months. The sessions followed a treatment manual, and were led by two trained facilitators in each centre, supported by a number of volunteers. Up to 12 dyads were invited to attend each group. MAIN OUTCOME MEASURES The primary outcome measures were self-reported quality of life for the person with dementia and psychological distress for the carer [General Health Questionnaire-28 item version (GHQ-28)]. Secondary outcome measures included autobiographical memory and activities of daily living for the person with dementia, carer stress for the carer and mood, relationship quality and service use and costs for both parties. RESULTS The intention-to-treat analysis identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes [self-reported quality of life in Alzheimer's disease: mean difference 0.07, standard error (SE) 0.65; F = 0.48; p = 0.53]. Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a subscale of the GHQ-28 at the 10-month end point (mean difference 1.25, SE 0.5; F = 8.28; p = 0.04). Compliance analyses suggested some benefits for people with dementia who attended more reminiscence sessions; however, carers attending more groups showed increased caregiving stress. Use of health- and social-care services was modest, with no significant difference in service use between conditions. Owing to negligible difference in quality-adjusted life-year gains (derived from European Quality of Life-5 Dimensions) between the conditions the planned full economic analysis was curtailed. CONCLUSIONS This trial does not provide support for the effectiveness or cost-effectiveness of joint reminiscence groups for people with dementia and their carers. Although there may be some beneficial effects for people with dementia who attend sessions as planned, this must be viewed in the context of raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions. TRIAL REGISTRATION Current Controlled Trials ISRCTN42430123. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 48. See the HTA programme website for further project information.