Dementia Clinical Trial
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | February 27, 2021 |
Est. primary completion date | February 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: • PLWDs without a caregiver |
Country | Name | City | State |
---|---|---|---|
Singapore | Duke-NUS Medical School | Singapore |
Lead Sponsor | Collaborator |
---|---|
Duke-NUS Graduate Medical School | Ministry of Health, Singapore, The Tsao Foundation |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Week 24 | |
Primary | 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. | Baseline, Week 24 | |
Primary | 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. | Baseline, Week 24 | |
Primary | 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. | Baseline, Week 24 | |
Secondary | 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. | Baseline, Week 24 |
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