Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Dementia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

It is currently estimated that 47 million people are living with dementia today and this number is expected to double in the next 20 years. Unfortunately, there has been limited advancement in medical treatments for dementia and new cost-effective approaches are needed. The utility of self-managemen...

It is currently estimated that 47 million people are living with dementia today and this number is expected to double in the next 20 years. Unfortunately, there has been limited advancement in medical treatments for dementia and new cost-effective approaches are needed. The utility of self-management has been proven to be of benefit in certain chronic diseases, however, very little work has been undertaken regarding self-management in people with dementia.The SHAPE self-management group therapy aims to significantly improve self-efficacy in people with mild to moderate dementia and to improve key health and mental health outcomes, carer stress and knowledge of dementia.SHAPE 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 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. E-learning resources will be provided for carers (study supporters) which covers the similar and complimentary material discussed in the group sessions for the participant with dementia. This trial uses 2:1 randomisation and will assess the clinical and cost effectiveness of SHAPE. Participants will be randomised to participate in the SHAPE intervention or continue with usual care. To assess the effectiveness of SHAPE at improving self-efficacy and secondary outcomes a battery of questionnaires will be administered to the participants and study supporters at baseline, 3 months after randomisation? after SHAPE participants have completed the intervention, and 9 months after randomisation. The answers to these questionnaires will be assessed and the results compared between the two groups of participants.

Tracking Information

NCT #
NCT04286139
Collaborators
  • The Research Council of Norway
  • Alzheimer's Society
  • National Health and Medical Research Council, Australia
  • University of Exeter
  • London School of Economics and Political Science
  • The University of New South Wales
  • The Hospital of Vestfold
Investigators
Principal Investigator: Ingelin Testad, PhD Helse Stavanger HF