DementiaSHAPENCT04286139
Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers
A study testing SHAPE in people with Dementia, run by Helse Stavanger HF at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- SHAPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 23 Aug 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Norway2 sites
Norwegian National Advisory Unit on Ageing and Health
Oslo, 0450
Centre for Age-related Medicine (SESAM), Stavanger University Hospital
Stavanger, Rogaland, 4011
United Kingdom2 sites
Cornwall Partnership NHS Foundation Trust
Bodmin, Cornwall, PL31 2QN
Devon Partnership NHS Trust
Exeter, Devon, EX2 5AF
Australia1 site
Neuroscience Research Australia, University of New South Wales
Sydney, New South Wales, 2031
About this study
Official title: Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
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.
Read the detailed 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-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.
- Conditions
- Dementia
- Being tested
- SHAPE
- Keywords
- Health promotion, Self-management, Online
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAPEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SHAPE Intervention | Experimental | 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. Receives: Behavioral: SHAPE |
| Treatment as usual | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
Measured: 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'.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start23 Aug 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- 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
- Responsible party
- Sponsor
- Investigators
- Ingelin Testad, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286139
- Sponsor's protocol ID
- 258388
- Acronym
- SHAPE
- Status last verified
- Aug 2021
- First submitted
- 19 Feb 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33036591
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT04286139
- Acronym / sponsor ID
- SHAPE / 258388
- Conditions
- Dementia
- Keywords
- Health promotion, Self-management, Online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- 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
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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-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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHAPE Intervention | Experimental | Behavioral: SHAPEThis 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. |
| Treatment as usual | No intervention | –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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAPEThe 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. | Behavioural | SHAPE Intervention |
Primary outcome
Change in general self-efficacy
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
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.
15 secondary outcomes
Change in mood (anxiety, depression)
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in 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)
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in Health-related Quality of life (HRQL)
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in Quality of life
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in health behaviours
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in cognition
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Cognition and function
Time frame: Baseline
Change in function
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in neuropsychiatric symptoms
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in carer stress
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in knowledge about dementia
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in perceived access to service use
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in cost of care
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Change in quality of adjusted life-years (QALY)
Time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 33036591Testad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingelin Testad, PhD principal investigator
Helse Stavanger HF
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHAPE in people with Dementia, run by Helse Stavanger HF at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general self-efficacy (time frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.