NCT04479033

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2021

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

July 16, 2020

Last Update Submit

July 16, 2020

Conditions

Keywords

community based caremultidisciplinary teamcomprehensive needs assessmentmoderate to severe dementiamixed-methods evaluation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Cost-effectiveness of intervention

    Baseline, Week 24

Study Arms (2)

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.

Other: Multidisciplinary collaborative model of community care management

Interventions

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.

Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • PLWDs without a caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

RECRUITING

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Angelique Chan, PhD

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Suen, PhD

CONTACT

Angelique Chan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

April 27, 2017

Primary Completion

February 27, 2021

Study Completion

February 27, 2021

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations