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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
Titles & IDs
Public title
Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers
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Scientific title
Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
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Secondary ID [1]
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258388
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Universal Trial Number (UTN)
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Trial acronym
SHAPE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in general self-efficacy
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [1]
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Change in mood (anxiety, depression)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [2]
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Change in wellbeing
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [3]
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Change in Health-related Quality of life (HRQL)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [4]
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Change in Health-related Quality of life (HRQL)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [5]
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Change in Quality of life
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [6]
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Change in health behaviours
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Assessment method [6]
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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'.
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Timepoint [6]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [7]
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Change in cognition
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Assessment method [7]
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Measured by the telephone Mini-Mental Status Examination (tMMSE). Assesses cognitive function in people with dementia. With a maximum score of 26, lower scores indicate greater cognitive issues.
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Timepoint [7]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [8]
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Cognition and function
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Assessment method [8]
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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
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Change in function
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [10]
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Change in neuropsychiatric symptoms
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [11]
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Change in carer stress
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Assessment method [11]
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Measured by the Relative Stress Scale (RSS), which consists of 15 items ranging from 0-4, high score indicates high burden on carers.
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Timepoint [11]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [12]
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Change in knowledge about dementia
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [13]
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Change in perceived access to service use
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [14]
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Change in cost of care
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Secondary outcome [15]
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Change in quality of adjusted life-years (QALY)
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2022
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Actual
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Sample size
Target
336
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Neuroscience Research Australia, University of New South Wales - Sydney
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Recruitment postcode(s) [1]
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2031 - Sydney
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Recruitment outside Australia
Country [1]
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Norway
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State/province [1]
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Rogaland
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Country [2]
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Norway
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State/province [2]
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Oslo
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Country [3]
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United Kingdom
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State/province [3]
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Devon
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Helse Stavanger HF
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Research Council of Norway
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Alzheimer's Society
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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National Health and Medical Research Council, Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Exeter
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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London School of Economics and Political Science
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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The University of New South Wales
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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The Hospital of Vestfold
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Address [7]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04286139
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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.
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Public notes
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Contacts
Principal investigator
Name
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Ingelin Testad, PhD
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Address
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Helse Stavanger HF
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Martha T Gjestsen, PhD
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Address
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Country
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Phone
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+47 92 80 55 25
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04286139