Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04286139




Registration number
NCT04286139
Ethics application status
Date submitted
19/02/2020
Date registered
26/02/2020
Date last updated
26/10/2021

Titles & IDs
Public title
Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers
Scientific title
Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
Secondary ID [1] 0 0
258388
Universal Trial Number (UTN)
Trial acronym
SHAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - SHAPE

Experimental: SHAPE Intervention - 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.

No intervention: Treatment as usual - 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


BEHAVIORAL: SHAPE
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in general self-efficacy
Timepoint [1] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [1] 0 0
Change in mood (anxiety, depression)
Timepoint [1] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [2] 0 0
Change in wellbeing
Timepoint [2] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [3] 0 0
Change in Health-related Quality of life (HRQL)
Timepoint [3] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [4] 0 0
Change in Health-related Quality of life (HRQL)
Timepoint [4] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [5] 0 0
Change in Quality of life
Timepoint [5] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [6] 0 0
Change in health behaviours
Timepoint [6] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [7] 0 0
Change in cognition
Timepoint [7] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [8] 0 0
Cognition and function
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Change in function
Timepoint [9] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [10] 0 0
Change in neuropsychiatric symptoms
Timepoint [10] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [11] 0 0
Change in carer stress
Timepoint [11] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [12] 0 0
Change in knowledge about dementia
Timepoint [12] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [13] 0 0
Change in perceived access to service use
Timepoint [13] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [14] 0 0
Change in cost of care
Timepoint [14] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcome [15] 0 0
Change in quality of adjusted life-years (QALY)
Timepoint [15] 0 0
Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)

Eligibility
Key inclusion criteria
* Diagnosis of dementia according to the ICD-10 classification or the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or V
* 65 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2022
Actual
Sample size
Target
336
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Rogaland
Country [2] 0 0
Norway
State/province [2] 0 0
Oslo
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Devon

Funding & Sponsors
Primary sponsor type
Government body
Name
Helse Stavanger HF
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Research Council of Norway
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Alzheimer's Society
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Exeter
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
London School of Economics and Political Science
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The University of New South Wales
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
The Hospital of Vestfold
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04286139
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Ingelin Testad, PhD
Address 0 0
Helse Stavanger HF
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Martha T Gjestsen, PhD
Address 0 0
Country 0 0
Phone 0 0
+47 92 80 55 25
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04286139