- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479033
Caring for Persons With Dementia and Their Caregivers in the Community
Caring for Persons With Dementia and Their Caregivers in the Community: Towards a Sustainable Community Based Dementia Care System
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johan Suen, PhD
- Phone Number: +65 97552066
- Email: johan@duke-nus.edu.sg
Study Contact Backup
- Name: Angelique Chan, PhD
- Phone Number: 65685 6516 5685
- Email: angelique.Chan@duke-nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 169857
- Recruiting
- Duke-NUS Medical School
-
Contact:
- Johan Suen, PhD
- Phone Number: +65 97552066
- Email: johan@duke-nus.edu.sg
-
Principal Investigator:
- Angelique Chan, PhD
-
Sub-Investigator:
- Johan Suen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
|
|
Experimental: Intervention
Weekly meeting/communication sessions with members of intervention team for a total of 24 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 24
|
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.
|
Baseline, Week 24
|
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.
|
Baseline, Week 24
|
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.
|
Baseline, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness of intervention
Time Frame: Baseline, Week 24
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Angelique Chan, PhD, Duke-NUS Graduate Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOH/NIC/COG05/2017-00
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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