An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT

Abstract

Background There are few effective interventions for dementia. Aim To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dementia. Objectives To undertake a randomised controlled trial of the Journeying through Dementia intervention compared with usual care, conduct an internal pilot testing feasibility, assess intervention delivery fidelity and undertake a qualitative exploration of participants’ experiences. Design A pragmatic two-arm individually randomised trial analysed by intention to treat. Participants A total of 480 people diagnosed with mild dementia, with capacity to make informed decisions, living in the community and not participating in other studies, and 350 supporters whom they identified, from 13 locations in England, took part. Intervention Those randomised to the Journeying through Dementia intervention (n = 241) were invited to take part in 12 weekly facilitated groups and four one-to-one sessions delivered in the community by secondary care staff, in addition to their usual care. The control group (n = 239) received usual care. Usual care included drug treatment, needs assessment and referral to appropriate services. Usual care at each site was recorded. Main outcome measures The primary outcome was Dementia-Related Quality of Life score at 8 months post randomisation, with higher scores representing higher quality of life. Secondary outcomes included resource use, psychological well-being, self-management, instrumental activities of daily living and health-related quality of life. Randomisation and blinding Participants were randomised in a 1 : 1 ratio. Staff conducting outcome assessments were blinded. Data sources Outcome measures were administered in participants’ homes at baseline and at 8 and 12 months post randomisation. Interviews were conducted with participants, participating carers and interventionalists. Results The mean Dementia-Related Quality of Life score at 8 months was 93.3 (standard deviation 13.0) in the intervention arm (n = 191) and 91.9 (standard deviation 14.6) in the control arm (n = 197), with a difference in means of 0.9 (95% confidence interval –1.2 to 3.0; p = 0.380) after adjustment for covariates. This effect size (0.9) was less than the 4 points defined as clinically meaningful. For other outcomes, a difference was found only for Diener’s Flourishing Scale (adjusted mean difference 1.2, 95% confidence interval 0.1 to 2.3), in favour of the intervention (i.e. in a positive direction). The Journeying through Dementia intervention cost £608 more than usual care (95% confidence interval £105 to £1179) and had negligible difference in quality-adjusted life-years (–0.003, 95% confidence interval –0.044 to 0.038). Therefore, the Journeying through Dementia intervention had a mean incremental cost per quality-adjusted life-year of –£202,857 (95% confidence interval –£534,733 to £483,739); however, there is considerable uncertainty around this. Assessed fidelity was good. Interviewed participants described receiving some benefit and a minority benefited greatly. However, negative aspects were also raised by a minority. Seventeen per cent of participants in the intervention arm and 15% of participants in the control arm experienced at least one serious adverse event. None of the serious adverse events were classified as related to the intervention. Limitations Study limitations include recruitment of an active population, delivery challenges and limitations of existing outcome measures. Conclusions The Journeying through Dementia programme is not clinically effective, is unlikely to be cost-effective and cannot be recommended in its existing format. Future work Research should focus on the creation of new outcome measures to assess well-being in dementia and on using elements of the intervention, such as enabling enactment in the community. Trial registration This trial is registered as ISRCTN17993825. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 24. See the NIHR Journals Library website for further project information.

Self-report instruments measuring aspects of self for people living with dementia: A systematic literature review of psychosocial interventions

“…Two studies explicitly stated that the measure of self was a primary outcome of the intervention (Quinn et al, 2016; Richards et al, 2019) and six studies reported on an aspect of self as a secondary outcome (Berk et al, 2019; Clare et al, 2019; Hindle et al, 2018; Marshall et al, 2015; Mountain et al, 2022; Pongan et al, 2017). The remaining studies did not differentiate between primary or secondary outcomes in relation to the chosen measures.…”

“…Mixed method studies were relatively of lower quality, often owing to lack of clarity around the rationale for their chosen methodological approach. The quantitative components of these studies were mostly of lower quality compared to qualitative components, although Mountain et al (2022) and Quinn et al (2016) met all criteria for both components. Werheid et al (2021) and Fitzsimmons and Buettner (2003) were both lower quality studies due to not meeting any qualitative quality criteria; however, their quantitative components, which were synthesised in this review, were of higher quality.…”

‘I feel more part of the world’: Participatory action research to develop post-diagnostic dementia support

“…• Enjoyment and benefits (Martin et al, 2015) such as anxiety reduction (Clare et al, 2019;Mountain et al, 2022); • Increased confidence and self-efficacy, (re)engagement in activities, fun and friendships (Sprange et al, 2015), • Enhanced self-management techniques (Toms et al, 2015),…”

“…• The potential to bridge the "care gap" often experienced in the early stages of dementia (Martin et al, 2013), • Empowerment of people living with dementia, fostering independence, reciprocity and the desire for social support (Clare et al, 2019;Mountain et al, 2022;Quinn, Toms, Jones, et al, 2016), • Cost effectiveness (Laakkonen et al, 2016).…”

The Effect of Self-Development Program for Improving Independence in Defective Students in SLB N 1 Lima Kaum Batusangkar

“…Therefore, the author conducted a study to increase independence in students with mental disabilities through self-development programs. Independence is an attitude of autonomy in which students are relatively free from the influence of the judgments, opinions, and beliefs of others (Charli, 2021;Mountain, 2022;Souri, 2018). With this autonomy, students are expected to be more responsible for themselves.…”