Clinical trial NCT04479033: Caring for Persons With Dementia and Their Caregivers in the Community
Official title: Caring for Persons With Dementia and Their Caregivers in the Community: Towards a Sustainable Community Based Dementia Care System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Cognitive Impairment
Keywords: community based care
multidisciplinary team
comprehensive needs assessment
moderate to severe dementia
mixed-methods evaluation
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: The Tsao Foundation
First posted: 2020-07-21
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

1. Explore the perceptions, behaviours, and underlying motivators and inhibitors of PLWDs, their caregivers, and members of the community
2. Assess the health, social, psychological, and emotional needs of community dwelling PLWDs and their caregivers
3. 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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in cognitive impairment at week 24.
timeFrame: Baseline, Week 24
measure: Change from baseline in caregiver stress and burden at week 24.
timeFrame: Baseline, Week 24
measure: Change from baseline in memory and behaviour problems at week 24.
timeFrame: Baseline, Week 24
measure: Change from baseline in health-related quality of life at week 24.
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Cost-effectiveness of intervention
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Medical School
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Angelique Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: