Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers

NCT04286139 | Completed DMC

• 1 other identifier: 258388
• Study Type: interventional
• Target: 210
• Locations: 3 countries
• Sites: 5

Brief Summary

This study aims to assess if an educational programme combining approaches of self-management, health promotion, and e-learning will improve self-efficacy and other key health and mental health outcomes for people with mild to moderate dementia.

Conditions

Dementia

Keywords

Health promotion; Self-management; Online

Outcome Measures

Primary Outcomes (1)

• Change in general self-efficacy

  Measured by the General Self-Efficacy Scale, a 10-item psychometric scale where each item is scored on a 4 point scale ranging from 'Not at all true' to 'Hardly true', to assess optimistic self-beliefs to cope with a variety of difficult demands in life.

  Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

Secondary Outcomes (15)

• Change in mood (anxiety, depression)

  Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

• Change in wellbeing

  Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

• Change in Health-related Quality of life (HRQL)

  Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

• Change in Health-related Quality of life (HRQL)

  Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

• Change in Quality of life

  Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

Other Outcomes (2)

• Promoting and hindering factors of the intervention

  3 months (Primary time-point)

• Replication and dissemination of the intervention

  Baseline to 10 weeks

Study Arms (2)

SHAPE Intervention

EXPERIMENTAL

This group will receive the online group based self-management course develop self-management skills in areas including decision making, symptom management and social interaction and to provide information on the disease process and the development of healthy behaviours in a supportive learning environment to prevent problems that are common in the later stages of the disease. Key themes of the intervention will include positive actions to improve and maintain health, how to talk about the impact of the disease on the life of the person with dementia, fear of losing independence and how to tackle and solve other sensitive issues. Running in parallel there will be an e-learning resource available to the carers which covers the similar material covered in the group sessions for the person with dementia, as well as some additional resources and signposting to help them in their role supporting the person with dementia.

Behavioral: SHAPE

Treatment as usual

NO INTERVENTION

Participants in the TAU arm will receive normal services such as clinical reviews, psychiatric appointments and other services when needed. With TAU as the comparator condition ensures that participants receive any needed services and enable comparison between current best practice and the new intervention of SHAPE

Interventions

SHAPE BEHAVIORAL

The SHAPE intervention provides information for carers, and maintains the dignity and autonomy of the person with dementia, supporting them in planning for the future with their family. The person with dementia attends an online 10 week facilitator lead group based course. It is designed to develop self-management skills in areas including decision-making, symptom management and social interaction. It also provides information on the disease process and the development of healthy behaviors in a supportive learning environment to prevent problems that are common in the later stages of the disease. The adjunctive e-learning platform for carers provides the same information that the person with dementia receives plus additional material and signposting to support them in their role. This will empower the whole family to support and enable more effective self-management by the person with dementia, and enhance their ability to plan ahead together and make key decisions jointly.

SHAPE Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of dementia according to the ICD-10 classification or the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or V
• years of age or older
• Mild to moderate dementia, as associated with tMMSE ≥15
• Ability to read and write
• Hearing and vision that are sufficiently good to work in a group setting
• Capacity to give consent for participation in the study
• Proficient in the language in which the intervention is provided
• Care partner willing to participate

You may not qualify if:

• A diagnosis of alcohol or drug abuse
• Lewy body dementias, Fronto-temporal lobar degeneration or Semantic dementia
• A limited life expectancy due to any terminal disease or other serious illness, other than dementia
• Chemotherapy or radiation treatment ongoing at enrolment
• Currently participating in health promotion or self-management group

Sponsors & Collaborators

• Helse Stavanger HF: lead
• The Research Council of Norway: collaborator
• Alzheimer's Society: collaborator
• National Health and Medical Research Council, Australia: collaborator
• University of Exeter: collaborator
• London School of Economics and Political Science: collaborator
• The University of New South Wales: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (5)

Neuroscience Research Australia, University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

Centre for Age-related Medicine (SESAM), Stavanger University Hospital

Stavanger, Rogaland, 4011, Norway

Location

Norwegian National Advisory Unit on Ageing and Health

Oslo, 0450, Norway

Location

Cornwall Partnership NHS Foundation Trust

Bodmin, Cornwall, PL31 2QN, United Kingdom

Location

Devon Partnership NHS Trust

Exeter, Devon, EX2 5AF, United Kingdom

Location

Related Publications (1)

• Testad I, Clare L, Anstey K, Selbaek G, Bjorklof GH, Henderson C, Dalen I, Gjestsen MT, Rhodes S, Rosvik J, Bollen J, Amos J, Kajander MM, Quinn L, Knapp M. Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial. BMC Public Health. 2020 Oct 9;20(1):1508. doi: 10.1186/s12889-020-09590-9.

  PMID: 33036591 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ingelin Testad, PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 26, 2020
• Study Start: August 23, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 13, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NO (2); GB (2)