DementiaNCT04479033
Caring for Persons With Dementia and Their Caregivers in the Community
A study testing Multidisciplinary collaborative model of community care management in people with Dementia and Cognitive Impairment, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
The study consists of two phases - i) a comprehensive assessment of biopsychosocial needs among cognitively impaired persons and their family caregivers residing in the Whampoa residential estate in Singapore ; ii) a quasi-experimental evaluation of a pilot community-based dementia care programme administered by a… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment
- What is being tested?
- Multidisciplinary collaborative model of community care management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Apr 2017to 27 Feb 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age and above.
- Singapore citizens or permanent residents.
- Lives within catchment area of Whampoa Constituency
- Screened positively for cognitive impairment (MMSE score of 15 and above)
- PLWDs must have a primary caregiver.
- Caregivers must be 21 years of age and above.
Who cannot join
- PLWDs without a caregiver
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Duke-NUS Medical School
Singapore, 169857
Johan Suen, PhD, +65 97552066, johan@duke-nus.edu.sg
Angelique Chan, PhD
About this study
Official title: Caring for Persons With Dementia and Their Caregivers in the Community: Towards a Sustainable Community Based Dementia Care System
The study consists of two phases - i) a comprehensive assessment of biopsychosocial needs among cognitively impaired persons and their family caregivers residing in the Whampoa residential estate in Singapore ; ii) a quasi-experimental evaluation of a pilot community-based dementia care programme administered by a multidisciplinary team of service providers. The intervention is a physician-enhanced dementia-specific care management programme that supports client dyads for up to six months and through community care management, person-centred communication, management of challenging behaviours, psychoeducation, geriatric medicine, and gerontological approaches. The intervention team consists of a nurse, social worker, care manager, physician, and 'Dementia Care Program Assistants' who specifically design personalised meaningful activities to engage persons living with dementia as well as provide caregivers with training in basic dementia caregiving.
Read the detailed description
To provide appropriate care for persons living with dementia (PLWDs) in the community, their needs (met, unmet, and latent) and that of their caregivers must be understood holistically. Local studies have yet to comprehensively examine the experiences of community dwelling older persons living with moderate to severe dementia and their caregivers, and the impact of an integrated community model of health care and psychosocial support. This study adopts a mixed-method approach to needs assessment and programme evaluation using qualitative in-depth interviews and quantitative surveys administered to participants assigned to control and intervention groups. The Hua-Mei Dementia Care System (HMDCS) is a programme that aims to empower and support both PLWDs and their caregivers through personalised care management, dementia-specific education, and cognitive training. The HMDCS addresses the multifaceted challenges faced by PLWD-caregiver dyads such as behavioural problems, psychological distress, lack of social participation, stigma, communication barriers, financial strain, and insufficient social support.
The study aims are to:
- Explore the perceptions, behaviours, and underlying motivators and inhibitors of PLWDs, their caregivers, and members of the community
- Assess the health, social, psychological, and emotional needs of community dwelling PLWDs and their caregivers
- Evaluate the effectiveness of the programme in reducing cognitive and functional decline, caregiver burden, as well as improving self-reported health status, social wellbeing, and quality of life of PLWD-caregiver dyads
- Conditions
- Dementia, Cognitive Impairment
- Being tested
- Multidisciplinary collaborative model of community care management
- Keywords
- community based care, multidisciplinary team, comprehensive needs assessment, moderate to severe dementia, mixed-methods evaluation
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary collaborative model of community care managementOther
An individualised care plan is developed for PLWDs-caregiver dyads who meet/communicate weekly with various members of the HMDCS team depending on the nature of their needs. Each dyad's care plan involves the diagnosis of problems (eg: memory problems, family conflicts, poor nutrition, fall risk, medication compliance, lack of long-term care arrangements), establishment of treatment goals (eg: caregiver education, awareness of long-term care planning, stabilising medical care at home, improving emotional support), and indicating specific interventions (eg: referrals to counsellors, specialist doctors, day rehabilitation centres; consultations at GP clinic; coordination of advanced care planning; installation of home safety devices; training caregivers to detect acute deterioration in PLWDs). Monitoring of the dyads' statuses and updating of care plans are performed throughout the duration of the programme.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants assigned to the control group had screened positive for cognitive impairment but refused the intervention. They were provided with a GP referral letter and information on helplines and caregiver support. Follow-up interviews were scheduled at week 24. |
| Intervention | Experimental | Weekly meeting/communication sessions with members of intervention team for a total of 24 weeks. Receives: Other: Multidisciplinary collaborative model of community care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cognitive impairment at week 24.
Mini-Mental State Examination is a 30-point test to screen for cognitive impairment. Scores ranging from 20 to 26 indicate some cognitive impairment, 10-19 indicate moderate to severe cognitive impairment and below 10 indicate very severe cognitive impairment.
Measured: Baseline, Week 24
Change from baseline in caregiver stress and burden at week 24.
Zarit Burden Interview is a 22-item instrument for measuring the caregiver's perceived burden of providing care. Questions focus on caregiver's health, psychological well-being, finances, social life and relationship between the caregiver and the PLWD.
Measured: Baseline, Week 24
Change from baseline in memory and behaviour problems at week 24.
Revised Memory and Behavior Problems Checklist is a 24-item (scored on a scale of 0-4) caregiver-report to measure behavioral problems in PLWDs. The items can be summed as a total score and 3 subscale scores in the domains of memory, depression, and disruptive behaviors. Parallel scores for caregiver reaction are also obtained. Such disruptive and challenging behaviors undermine quality of life in PWDs and place both an emotional and financial burden on their caregivers.
Measured: Baseline, Week 24
Change from baseline in health-related quality of life at week 24.
Euro-Qol-5D- EQ5D is a commonly used 5-item scale to measure health-related quality of life.
Measured: Baseline, Week 24
Secondary outcomes (1)
Cost-effectiveness of intervention
Cost-effectiveness of the new model of care will be assessed using the incremental cost-effectiveness ratio (ICER) with respect to the control group. Cost will be assessed by recording utilization of health care and long-term care services and their average unit costs. The calculated ICER will show the cost of a quality-adjusted life year (QALY) saved by the new model of care. Effectiveness will be assessed by computing the average quality-adjusted life years left to live by the dementia participant in both groups. As the intervention is not assumed to be life-extending, study groups will only differ through their quality of life as measured by EQ5D weights. We will account for the quality of life of both PLWDs and their caregivers and sum their respective contributions.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start27 Apr 2017
- Primary completion27 Feb 2021 (estimated)
- Study completion27 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, The Tsao Foundation
- Responsible party
- Principal investigator, Angelique Chan, Duke-NUS Graduate Medical School
- Investigators
- Angelique Chan, PhD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479033
- Sponsor's protocol ID
- MOH/NIC/COG05/2017-00
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Persons With Dementia and Their Caregivers in the Community: Towards a Sustainable Community Based Dementia Care System
- ClinicalTrials.gov ID
- NCT04479033
- Acronym / sponsor ID
- MOH/NIC/COG05/2017-00
- Conditions
- Dementia, Cognitive Impairment
- Keywords
- community based care, multidisciplinary team, comprehensive needs assessment, moderate to severe dementia, mixed-methods evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, The Tsao Foundation
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 27 Feb 2021 (estimated)
- Study completion
- 27 Feb 2021 (estimated)
- First posted
- 21 Jul 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.
The study consists of two phases - i) a comprehensive assessment of biopsychosocial needs among cognitively impaired persons and their family caregivers residing in the Whampoa residential estate in Singapore ; ii) a quasi-experimental evaluation of a pilot community-based dementia care programme administered by a multidisciplinary team of service providers. The intervention is a physician-enhanced dementia-specific care management programme that supports client dyads for up to six months and through community care management, person-centred communication, management of challenging behaviours, psychoeducation, geriatric medicine, and gerontological approaches. The intervention team consists of a nurse, social worker, care manager, physician, and 'Dementia Care Program Assistants' who specifically design personalised meaningful activities to engage persons living with dementia as well as provide caregivers with training in basic dementia caregiving.
Detailed description
To provide appropriate care for persons living with dementia (PLWDs) in the community, their needs (met, unmet, and latent) and that of their caregivers must be understood holistically. Local studies have yet to comprehensively examine the experiences of community dwelling older persons living with moderate to severe dementia and their caregivers, and the impact of an integrated community model of health care and psychosocial support. This study adopts a mixed-method approach to needs assessment and programme evaluation using qualitative in-depth interviews and quantitative surveys administered to participants assigned to control and intervention groups. The Hua-Mei Dementia Care System (HMDCS) is a programme that aims to empower and support both PLWDs and their caregivers through personalised care management, dementia-specific education, and cognitive training. The HMDCS addresses the multifaceted challenges faced by PLWD-caregiver dyads such as behavioural problems, psychological distress, lack of social participation, stigma, communication barriers, financial strain, and insufficient social support.
The study aims are to:
- Explore the perceptions, behaviours, and underlying motivators and inhibitors of PLWDs, their caregivers, and members of the community
- Assess the health, social, psychological, and emotional needs of community dwelling PLWDs and their caregivers
- Evaluate the effectiveness of the programme in reducing cognitive and functional decline, caregiver burden, as well as improving self-reported health status, social wellbeing, and quality of life of PLWD-caregiver dyads
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants assigned to the control group had screened positive for cognitive impairment but refused the intervention. They were provided with a GP referral letter and information on helplines and caregiver support. Follow-up interviews were scheduled at week 24. |
| Intervention | Experimental | Other: Multidisciplinary collaborative model of community care managementWeekly meeting/communication sessions with members of intervention team for a total of 24 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 60 years of age and above.
- Singapore citizens or permanent residents.
- Lives within catchment area of Whampoa Constituency
- Screened positively for cognitive impairment (MMSE score of 15 and above)
- PLWDs must have a primary caregiver.
Key exclusion criteria (1 listed)
- PLWDs without a caregiver
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 |
|---|---|---|
| Multidisciplinary collaborative model of community care managementAn individualised care plan is developed for PLWDs-caregiver dyads who meet/communicate weekly with various members of the HMDCS team depending on the nature of their needs. Each dyad's care plan involves the diagnosis of problems (eg: memory problems, family conflicts, poor nutrition, fall risk, medication compliance, lack of long-term care arrangements), establishment of treatment goals (eg: caregiver education, awareness of long-term care planning, stabilising medical care at home, improving emotional support), and indicating specific interventions (eg: referrals to counsellors, specialist doctors, day rehabilitation centres; consultations at GP clinic; coordination of advanced care planning; installation of home safety devices; training caregivers to detect acute deterioration in PLWDs). Monitoring of the dyads' statuses and updating of care plans are performed throughout the duration of the programme. | Other | Intervention |
Primary outcome
Change from baseline in cognitive impairment at week 24.
Time frame: Baseline, Week 24
Mini-Mental State Examination is a 30-point test to screen for cognitive impairment. Scores ranging from 20 to 26 indicate some cognitive impairment, 10-19 indicate moderate to severe cognitive impairment and below 10 indicate very severe cognitive impairment.
Change from baseline in caregiver stress and burden at week 24.
Time frame: Baseline, Week 24
Zarit Burden Interview is a 22-item instrument for measuring the caregiver's perceived burden of providing care. Questions focus on caregiver's health, psychological well-being, finances, social life and relationship between the caregiver and the PLWD.
Change from baseline in memory and behaviour problems at week 24.
Time frame: Baseline, Week 24
Revised Memory and Behavior Problems Checklist is a 24-item (scored on a scale of 0-4) caregiver-report to measure behavioral problems in PLWDs. The items can be summed as a total score and 3 subscale scores in the domains of memory, depression, and disruptive behaviors. Parallel scores for caregiver reaction are also obtained. Such disruptive and challenging behaviors undermine quality of life in PWDs and place both an emotional and financial burden on their caregivers.
Change from baseline in health-related quality of life at week 24.
Time frame: Baseline, Week 24
Euro-Qol-5D- EQ5D is a commonly used 5-item scale to measure health-related quality of life.
1 secondary outcome
Cost-effectiveness of intervention
Time frame: Baseline, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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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.
Angelique Chan, PhD principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary collaborative model of community care management in people with Dementia and Cognitive Impairment, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Suen, PhD (+65 97552066, johan@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cognitive impairment at week 24. (time frame: Baseline, Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.