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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04286139
Ethics application status
Date submitted
19/02/2020
Date registered
26/02/2020
Date last updated
28/07/2020

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
Behaviour - SHAPE

Experimental: SHAPE Intervention - This group will receive the 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


Behaviour: 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 a 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
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
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) - Measured by the Cornell Scale for Depression in Dementia (CSDD) for participants with dementia. Scale ranges from 0-38, where high score indicates high symptom load.
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 - Measured by the Sense of Competence Questionnaire Short version (SSCQ). This is a 7-item questionnaire, scale scores range from 7-35, where higher scores indicate higher sense of competence, which is an important factor in their 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) - Measured by the Dementia Quality of Life Scale (DEMQOL) for participants with dementia. A 28 item interviewer-administered questionnaire with a score range of 28 to 112, higher scores indicating better 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) - Measured by the Dementia Quality of Life Scale (DEMQOL) proxy version. A 31 item interviewer-administered questionnaire answered by a carer with a score range of 31 to 124, higher scores indicating better 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 - Measured by EQ-5D-5L. Descriptive measure of quality of life comprising 5 Dimensions With 5 Levels each, scores can be converted to a single summary index number. A visual analog scale records self-rated health ranging 0-100, high score indicates good health.
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 - Measured by Self-reported health behaviour change questionnaire. Comprises 17 questions about specific health-related change that occurred during each time period, and if yes, how much of a change ranging from 'a little change', 'quite a bit of change', and 'great change'.
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 - Measured by the Mini-Mental Status Examination MMSE). Assesses cognitive function in people with dementia. With a maximum score of 30, lower scores indicate greater cognitive issues.
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 - Measured by the Modified Clinical Dementia Rating Scale (mCDR), a 5-point likert scale used to characterize six domains of cognitive and functional performance, level of impairment/dementia is ranging from 0=Normal, 0.5 = Very Mild Dementia, 1 = Mild Dementia, 2 = Moderate Dementia, 3 = Severe Dementia
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Change in function - Measured by the Functional Activities Questionnaire (FAQ). 10 items measuring instrumental activities of daily living (IADLs), with sum score ranging 0-30. Higher score indicates impaired 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 - Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q), an informant based questionnaire assessing the presence and severity of 12 Neuropsychiatric Symptoms. Severity scores range from 0-36, where higher scores indicate more severe behavioural and psychological symptoms of dementia. Distress scores range from 0-60, where higher values represent higher levels of distress due to 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 - Measured by the Relative Stress Scale (RSS), which consists of 15 items ranging from 0-4, high score indicates high burden on carers.
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 - Measured by the Dementia Knowledge Assessment Scale (DKAS). Comprising 25 items with statements about the condition, including general characteristics, symptoms, risk factors, care and treatment. Respondents answer on a modified Likert scale with five response options: false, probably false, probably true, true, don't know.
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 - Measured by the Client Service Receipt Inventory (CSRI). A validated tool to gather information on current living arrangements, medication, use of hospital, community-based and day services.
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 - Measured by the Client Service Receipt Inventory (CSRI). A validated tool to gather information on current living arrangements, medication, use of hospital, community-based and day services.
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) - Measured by EuroQoL Instrument EQ-5D-5L. Descriptive measure of quality of life comprising 5 Dimensions With 5 Levels each, scores can be converted to a single summary index number. A visual analog scale records self-rated health ranging 0-100, high score indicates good health.
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 MMSE =18

- 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
Gender
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
Supportive Care
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Other
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/show/NCT04286139
Trial related presentations / publications
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
martha.therese.gjestsen@sus.no
Contact person for scientific queries

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