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Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial.

Abstract

BACKGROUND

Group cognitive stimulation therapy programmes can benefit cognition and quality of life for people with dementia. Evidence for home-based, carer-led cognitive stimulation interventions is limited.

OBJECTIVES

To evaluate the clinical effectiveness and cost-effectiveness of carer-delivered individual cognitive stimulation therapy (iCST) for people with dementia and their family carers, compared with treatment as usual (TAU).

DESIGN

A multicentre, single-blind, randomised controlled trial assessing clinical effectiveness and cost-effectiveness. Assessments were at baseline, 13 weeks and 26 weeks (primary end point).

SETTING

Participants were recruited through Memory Clinics and Community Mental Health Teams for older people.

PARTICIPANTS

A total of 356 caregiving dyads were recruited and 273 completed the trial.

INTERVENTION

iCST consisted of structured cognitive stimulation sessions for people with dementia, completed up to three times weekly over 25 weeks. Family carers were supported to deliver the sessions at home.

MAIN OUTCOME MEASURES

Primary outcomes for the person with dementia were cognition and quality of life. Secondary outcomes included behavioural and psychological symptoms, activities of daily living, depressive symptoms and relationship quality. The primary outcome for the family carers was mental/physical health (Short Form questionnaire-12 items). Health-related quality of life (European Quality of Life-5 Dimensions), mood symptoms, resilience and relationship quality comprised the secondary outcomes. Costs were estimated from health and social care and societal perspectives.

RESULTS

There were no differences in any of the primary outcomes for people with dementia between intervention and TAU [cognition: mean difference -0.55, 95% confidence interval (CI) -2.00 to 0.90; p-value = 0.45; self-reported quality of life: mean difference -0.02, 95% CI -1.22 to 0.82; p-value = 0.97 at the 6-month follow-up]. iCST did not improve mental/physical health for carers. People with dementia in the iCST group experienced better relationship quality with their carer, but there was no evidence that iCST improved their activities of daily living, depression or behavioural and psychological symptoms. iCST seemed to improve health-related quality of life for carers but did not benefit carers' resilience or their relationship quality with their relative. Carers conducting more sessions had fewer depressive symptoms. Qualitative data suggested that people with dementia and their carers experienced better communication owing to iCST. Adjusted mean costs were not significantly different between the groups. From the societal perspective, both health gains and cost savings were observed.

CONCLUSIONS

iCST did not improve cognition or quality of life for people with dementia, or carers' physical and mental health. Costs of the intervention were offset by some reductions in social care and other services. Although there was some evidence of improvement in terms of the caregiving relationship and carers' health-related quality of life, iCST does not appear to deliver clinical benefits for cognition and quality of life for people with dementia. Most people received fewer than the recommended number of iCST sessions. Further research is needed to ascertain the clinical effectiveness of carer-led cognitive stimulation interventions for people with dementia.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN65945963.

FUNDING

This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 64. See the NIHR Journals Library website for further information.

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  • Authors+Show Affiliations

    ,

    Division of Psychiatry, University College London, London, UK.

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    Division of Psychiatry, University College London, London, UK.

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    Division of Psychiatry, University College London, London, UK. School of Medicine, Institute of Mental Health, Nottingham, UK.

    ,

    North Wales Organisation for Randomised Trials in Health, Institute of Medical and Social Care Research, Bangor, UK.

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    North Wales Organisation for Randomised Trials in Health, Institute of Medical and Social Care Research, Bangor, UK.

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    Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.

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    North Wales Organisation for Randomised Trials in Health, Institute of Medical and Social Care Research, Bangor, UK.

    ,

    Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.

    ,

    Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.

    ,

    Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.

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    Institute of Rehabilitation, University of Hull, Hull, UK.

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    Devon Partnership NHS Trust, Exeter, UK.

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    Dorset Healthcare University NHS Foundation Trust, Dorset, UK.

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    Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.

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    Lincolnshire Partnership NHS Foundation Trust, Lincoln, UK.

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    College of Medicine, Swansea University, Swansea, UK.

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    Norfolk and Suffolk NHS Foundation Trust, Norwich, UK. South London and Maudsley NHS Foundation Trust, Health Innovation Network South London, London, UK.

    ,

    Dementia Services Development Centre Wales, Bangor University, Bangor, UK.

    School of Medicine, Institute of Mental Health, Nottingham, UK.

    Source

    MeSH

    Aged
    Aged, 80 and over
    Anxiety
    Caregivers
    Cognitive Behavioral Therapy
    Cost-Benefit Analysis
    Dementia
    Depression
    England
    Female
    Health Status
    Humans
    Male
    Mental Health
    Quality of Life
    Quality-Adjusted Life Years

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    26292178

    Citation

    Orgeta, Vasiliki, et al. "Individual Cognitive Stimulation Therapy for Dementia: a Clinical Effectiveness and Cost-effectiveness Pragmatic, Multicentre, Randomised Controlled Trial." Health Technology Assessment (Winchester, England), vol. 19, no. 64, 2015, pp. 1-108.
    Orgeta V, Leung P, Yates L, et al. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Health Technol Assess. 2015;19(64):1-108.
    Orgeta, V., Leung, P., Yates, L., Kang, S., Hoare, Z., Henderson, C., ... Orrell, M. (2015). Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Health Technology Assessment (Winchester, England), 19(64), pp. 1-108. doi:10.3310/hta19640.
    Orgeta V, et al. Individual Cognitive Stimulation Therapy for Dementia: a Clinical Effectiveness and Cost-effectiveness Pragmatic, Multicentre, Randomised Controlled Trial. Health Technol Assess. 2015;19(64):1-108. PubMed PMID: 26292178.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. AU - Orgeta,Vasiliki, AU - Leung,Phuong, AU - Yates,Lauren, AU - Kang,Sujin, AU - Hoare,Zoe, AU - Henderson,Catherine, AU - Whitaker,Chris, AU - Burns,Alistair, AU - Knapp,Martin, AU - Leroi,Iracema, AU - Moniz-Cook,Esme D, AU - Pearson,Stephen, AU - Simpson,Stephen, AU - Spector,Aimee, AU - Roberts,Steven, AU - Russell,Ian T, AU - de Waal,Hugo, AU - Woods,Robert T, AU - Orrell,Martin, PY - 2015/8/21/entrez PY - 2015/8/21/pubmed PY - 2016/5/19/medline SP - 1 EP - 108 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 19 IS - 64 N2 - BACKGROUND: Group cognitive stimulation therapy programmes can benefit cognition and quality of life for people with dementia. Evidence for home-based, carer-led cognitive stimulation interventions is limited. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of carer-delivered individual cognitive stimulation therapy (iCST) for people with dementia and their family carers, compared with treatment as usual (TAU). DESIGN: A multicentre, single-blind, randomised controlled trial assessing clinical effectiveness and cost-effectiveness. Assessments were at baseline, 13 weeks and 26 weeks (primary end point). SETTING: Participants were recruited through Memory Clinics and Community Mental Health Teams for older people. PARTICIPANTS: A total of 356 caregiving dyads were recruited and 273 completed the trial. INTERVENTION: iCST consisted of structured cognitive stimulation sessions for people with dementia, completed up to three times weekly over 25 weeks. Family carers were supported to deliver the sessions at home. MAIN OUTCOME MEASURES: Primary outcomes for the person with dementia were cognition and quality of life. Secondary outcomes included behavioural and psychological symptoms, activities of daily living, depressive symptoms and relationship quality. The primary outcome for the family carers was mental/physical health (Short Form questionnaire-12 items). Health-related quality of life (European Quality of Life-5 Dimensions), mood symptoms, resilience and relationship quality comprised the secondary outcomes. Costs were estimated from health and social care and societal perspectives. RESULTS: There were no differences in any of the primary outcomes for people with dementia between intervention and TAU [cognition: mean difference -0.55, 95% confidence interval (CI) -2.00 to 0.90; p-value = 0.45; self-reported quality of life: mean difference -0.02, 95% CI -1.22 to 0.82; p-value = 0.97 at the 6-month follow-up]. iCST did not improve mental/physical health for carers. People with dementia in the iCST group experienced better relationship quality with their carer, but there was no evidence that iCST improved their activities of daily living, depression or behavioural and psychological symptoms. iCST seemed to improve health-related quality of life for carers but did not benefit carers' resilience or their relationship quality with their relative. Carers conducting more sessions had fewer depressive symptoms. Qualitative data suggested that people with dementia and their carers experienced better communication owing to iCST. Adjusted mean costs were not significantly different between the groups. From the societal perspective, both health gains and cost savings were observed. CONCLUSIONS: iCST did not improve cognition or quality of life for people with dementia, or carers' physical and mental health. Costs of the intervention were offset by some reductions in social care and other services. Although there was some evidence of improvement in terms of the caregiving relationship and carers' health-related quality of life, iCST does not appear to deliver clinical benefits for cognition and quality of life for people with dementia. Most people received fewer than the recommended number of iCST sessions. Further research is needed to ascertain the clinical effectiveness of carer-led cognitive stimulation interventions for people with dementia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN65945963. FUNDING: This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 64. See the NIHR Journals Library website for further information. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/26292178/Individual_cognitive_stimulation_therapy_for_dementia:_a_clinical_effectiveness_and_cost_effectiveness_pragmatic_multicentre_randomised_controlled_trial_ L2 - https://doi.org/10.3310/hta19640 DB - PRIME DP - Unbound Medicine ER -