Which of the following are effective psychosocial interventions designed to improve quality of life for a person living with dementia select all that apply?

Summary

Background

There is an urgent clinical need for evidence-based psychosocial interventions for people with mild dementia. We aimed to determine the clinical benefits and cost-effectiveness of Journeying through Dementia [JtD], an intervention designed to promote wellbeing and independence in people with mild dementia.

Methods

We did a single-blind, parallel group, individually randomised, phase 3 trial at 13 National Health Service sites across England. People with mild dementia [Mini-Mental State Examination score of ≥18] who lived in the community were eligible for inclusion. Patients were centrally randomly assigned [1:1] to receive the JtD intervention plus standard care [JtD group] or standard care only [standard care group]. Randomisation was stratified by study site. The JtD intervention included 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life [DEMQOL] 8 months after randomisation, assessed according to the intention-to-treat principle. Only outcome assessors were masked to group assignment. A cost-effectiveness analysis reported cost per quality-adjusted life-year [QALY] from a UK NHS and social care perspective. The study is registered with ISRCTN, ISRCTN17993825.

Findings

Between Nov 30, 2016, and Aug 31, 2018, 1183 patients were screened for inclusion, of whom 480 [41%] participants were randomly assigned: 241 [50%] to the JtD group and 239 [50%] to the standard care group. Intervention adherence was very good: 165 [68%] of 241 participants in the JtD group attended at least ten of the 16 sessions. Mean DEMQOL scores at 8 months were 93·3 [SD 13·0] for the JtD group and 91·9 [SD 14·6] for the control group. Difference in means was 0·9 [95% CI –1·2 to 3·0; p=0·38] after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88 000 to –£205 000, suggesting that JtD was not cost-effective. Unrelated serious adverse events were reported by 40 [17%] patients in the JtD group and 35 [15%] patients in the standard care group.

Interpretation

In common with other studies, the JtD intervention was not proven effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers. Additionally, people with dementia were actively involved as participants and study advisers throughout. More research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse, and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale.

Funding

UK National Institute of Health Research Health Technology Assessment Programme.

Introduction

The Global Action Plan on Dementia

1

WHO
Global action plan on the public health response to dementia 2017–2025.

• Google Scholar

acknowledges the value of providing non-pharmacological [or psychosocial] interventions to people following diagnosis. These interventions are physical, cognitive, or social activities that maintain or improve functioning, interpersonal relationships, and wellbeing in people with dementia.

Therefore, non-pharmacological interventions encompass a range of interventions as identified and described in a comprehensive evidence review.

The importance of psychosocial interventions for those with mild dementia, including those recently diagnosed, is driven by the knowledge that a cure is unlikely in the near future and for people with dementia to be supported in order to live as well as possible with the condition.

, 

The 2015 national audit of UK memory services found that access to post-diagnostic services had increased but that the assistance people received was patchy and inconsistent.

5

• Hodge S
• Hailey E

Second English National Memory Clinic Audit Report.

• Google Scholar

At the time of the audit there were very few evidence-based psychosocial interventions for those with mild dementia and people were beginning to articulate their needs.

Research in context

Evidence before this study

People with dementia are being identified and diagnosed earlier and there are consequent demands from this patient group for meaningful, individualised, and non-pharmacological or psychosocial interventions from the point of diagnosis. This need is underscored by national and international policies. A scoping review of evidence of psychosocial interventions for people with mild-to-moderate dementia was done alongside this study. A systematic search strategy was done of national health service evidence [MEDLINE, PsycINFO, CINAHL, Web of Science, and Scopus] for relevant papers from Jan 1, 2000, to 2018 due to poor rates of diagnosis before 2000. The search terms used were [dement* OR Alzheimer*] AND [mild* OR early OR newly OR initial OR “home-based” OR “home based” OR “home-dwelling” OR “home dwelling”] AND [“therap*” OR “counselling” OR “training” OR “intervention* “OR “education*” OR “rehabilitation” OR “reminiscence” OR “psycho*2] NOT [“severe “OR “long term” OR “long-term” OR institution* OR “nursing home*” OR “nursing-home*” OR “care home*” OR “care-home*” OR “hospital*”] NOT [“drug*” OR “medic*” OR “pharmacologic*”]. Additional search terms such as therapies [eg, “art therapy”, “cognitive behavioural therapy”, and “psychotherapy”] and names of specific interventions were not used within this review due to resource limitations. Database searches were complemented by following up results from existing reviews and reference lists of key papers and relevant book chapters. Findings confirmed the need for stage-specific interventions, the value of a classification system for psychosocial interventions, and the need for pragmatic trials to test these interventions. However, when we commenced this study there were very few evidence-based psychosocial interventions for people following diagnosis—in particular for people without carer support. Involvement of patients with dementia in intervention design was scarce.

Added value of this study

The Journeying through Dementia [JtD] randomised trial is one of the largest UK trials of a psychosocial intervention for people with mild dementia. The intervention was co-designed with people with mild dementia and informal carers and can be tailored to meet individual needs. Unlike most psychosocial interventions, people with dementia can take part without accompanying carers. We have shown it is possible to recruit and retain people with dementia as trial participants and to sustain their active involvement as study advisers; we had very good adherence. However, trial results found that the intervention did not improve quality of life at 8 months after randomisation and was unlikely to be cost-effective. One of the secondary outcomes, Diener's Flourishing Scale, did have a significant effect in favour of the intervention.

Implications of all the available evidence

Other large-scale studies of psychosocial interventions for people with mild dementia have reported few clinical benefits and low cost-effectiveness. This study identified the need for reappraisal of methods. Our findings suggest that future randomised trials should use dementia-specific outcome measures of wellbeing and methods that can capture and record small, meaningful changes. We need to consider how to recruit people with dementia from diverse populations. Additionally, we require unobtrusive methods of assessing intervention fidelity. Finally, we must consider the service capacity required to deliver the psychosocial interventions and support that people with mild dementia say that they need.

Service gaps led to the co-creation of the Journeying through Dementia [JtD] intervention, which involved people with dementia informing us of what they considered would be helpful following diagnosis, including potential intervention topics and methods of intervention delivery.

6

• Sprange K
• Mountain GA
• Shortland K
• et al.

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial.

• Crossref
• PubMed
• Scopus [22]
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Social cognitive theory

underpinned the design of the JtD intervention, thereby including mechanisms to increase self-efficacy and effective problem-solving. It was postulated that these mechanisms would foster positive emotions, relationships, ability to self-manage, retention of functional skills, and wellbeing. The resulting intervention included a mix of facilitated group and one-to-one sessions over 12 weeks [maximum duration considered viable in a national health service [NHS] context]. This was found to be acceptable to people with dementia and their carers.

6

• Sprange K
• Mountain GA
• Shortland K
• et al.

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial.

• Crossref
• PubMed
• Scopus [22]
• Google Scholar

Over time services have become more aware of the needs of people after diagnosis, but the ability to respond to the complexity of needs that individuals can present with is restricted, in particular, how people can be enabled to adapt their lifestyles to living with dementia. The primary aim of the trial was to determine the clinical benefits and cost-effectiveness of the JtD intervention for people with mild dementia.

Methods