NCT03030027

Brief Summary

The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

January 8, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

January 9, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 16, 2019

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

January 8, 2017

Last Update Submit

April 12, 2019

Conditions

Keywords

IntergenerationReappraisalCaregiving

Outcome Measures

Primary Outcomes (2)

  • Change in Life Satisfaction (LS): scale

    Each response was rated from to 7 on each of the 5 items of the scale with higher score indicating higher level of life satisfaction

    Change from Baseline LS through study completion, an average of 2 months

  • Change in Center for Epidemiologic Studies Depressive Scale (CESD)

    Each response was rated from 0 to 3 on a scale of the frequency of the occurrence of the symptom in the past week. Higher scores would suggest a higher

    Change from Baseline CESD through study completion, an average of 2 months

Secondary Outcomes (1)

  • Change in Zarit Burden Interview (ZBI)

    Change from Baseline ZBI through study completion, an average of 2 months

Study Arms (2)

Connecting Through Caregiving

EXPERIMENTAL

This arm focuses on perspective-taking reappraisal procedures.

Behavioral: Connecting Through Caregiving

Basic Skills Building

OTHER

This arm focuses on skill building.

Other: Basic Skills Building

Interventions

The Connecting Through Caregiving intervention focuses on reappraisal exercises on intergeneration relationships in caregiving, involving the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy for the care-recipient, 3) help-seeking in caregiving, 4) balancing self-care and caring and 5) negotiating action plans.

Connecting Through Caregiving

Skill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation

Basic Skills Building

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study participants will be primary caregivers aged 18 or older and who have been caring for persons (aged 60 or above) with a physician diagnosis of Alzheimer's disease in the mild to moderate range as determined by the Clinical Dementia Rating Scale.
  • Primary caregivers are those who have been providing unpaid care for more than 14 hours a week for at least the past three months.
  • The care should involve day-to-day decision-making as well as any of the following: feeding, dressing, bathing, toileting, housework, preparing meals, medication and handling finances.
  • They can be daughter/son or daughter-/son-in-law of the care recipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Active Ageing

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Alma Au, {PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2017

First Posted

January 24, 2017

Study Start

January 9, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 16, 2019

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations