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.
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 online 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, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
210
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.
Neuroscience Research Australia, University of New South Wales
Sydney, New South Wales, Australia
Centre for Age-related Medicine (SESAM), Stavanger University Hospital
Stavanger, Rogaland, Norway
Norwegian National Advisory Unit on Ageing and Health
Oslo, Norway
Cornwall Partnership NHS Foundation Trust
Bodmin, Cornwall, United Kingdom
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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Devon Partnership NHS Trust
Exeter, Devon, United Kingdom
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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'.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in cognition
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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
Time frame: Baseline
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)