Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial.

Carers Cost-effectiveness Dementia E-learning Group intervention Health promotion Intervention Randomised controlled trial Self-efficacy Self-management

Journal

BMC public health
ISSN: 1471-2458
Titre abrégé: BMC Public Health
Pays: England
ID NLM: 100968562

Informations de publication

Date de publication:
09 Oct 2020
Historique:
received: 19 08 2020
accepted: 22 09 2020
entrez: 10 10 2020
pubmed: 11 10 2020
medline: 20 5 2021
Statut: epublish

Résumé

With an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia. The SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia. This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia. ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT04286139.

Sections du résumé

BACKGROUND BACKGROUND
With an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia.
METHODS METHODS
The SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia.
DISCUSSION CONCLUSIONS
This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT04286139.

Identifiants

pubmed: 33036591
doi: 10.1186/s12889-020-09590-9
pii: 10.1186/s12889-020-09590-9
pmc: PMC7545375
doi:

Banques de données

ClinicalTrials.gov
['NCT04286139']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1508

Subventions

Organisme : EU Joint Programme - Neurodegenerative Disease Research
ID : HESOCARE-329-013

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Auteurs

Ingelin Testad (I)

Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway. itestad@gmail.com.
University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK. itestad@gmail.com.
Department of Old Age Psychiatry, Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London, UK. itestad@gmail.com.

Linda Clare (L)

REACH: The Centre for Research in Ageing and Cognitive Health, University of Exeter, St Luke's Campus, Exeter, UK.

Kaarin Anstey (K)

UNSW Ageing Futures Institute, University of New South Wales, Randwick, Australia.
Neuroscience Research Australia, Randwick, Australia.

Geir Selbæk (G)

Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.
Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.
Faculty of Medicine, University of Oslo, Oslo, Norway.

Guro Hanevold Bjørkløf (GH)

Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.

Catherine Henderson (C)

Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.

Ingvild Dalen (I)

Department of Research, Section of Biostatistics, Stavanger University Hospital, Stavanger, Norway.

Martha Therese Gjestsen (MT)

Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.

Shelley Rhodes (S)

University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.

Janne Røsvik (J)

Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.

Jessica Bollen (J)

University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.

Jessica Amos (J)

UNSW Ageing Futures Institute, University of New South Wales, Randwick, Australia.

Martine Marie Kajander (MM)

Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.
Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Lynne Quinn (L)

University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.

Martin Knapp (M)

Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.

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