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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03552159
Other study ID # HCPF2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2012
Est. completion date June 30, 2016

Study information

Verified date May 2018
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers.


Description:

The study compared two telephone interventions using a four-month longitudinal randomized controlled trial. For the first four weeks, all participants received the same psychoeducation program via telephone. Then for the following four months, eight biweekly telephone follow-up calls were carried out. For these eight follow-up calls, participants were randomized into either one of the two following groups with different conditions. For the Psychoeducation with BA (PsyED-BA) group, participants would receive eight biweekly sessions of BA practice focused on pleasant event scheduling and improving communications. For the Psychoeducation only (PsyED Only) group, there would be eight biweekly sessions of general discussion of psychoeducation and related information


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date June 30, 2016
Est. primary completion date December 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria:

They were caregivers aged 25 or above and must have be caring for a care recipient diagnosed with Alzheimer's disease for at least 3 months. They should be the primary caregiver and a spouse, kin (e.g. daughter/son or daughter/son-in-law) or sibling of the care recipient.

Exclusion Criteria:

To ensure intervention fidelity, participants who showed signs of severe intellectual deficits, demonstrate suicidal ideation, exhibit evidence of psychotic disorders, or cannot read or speak fluent Chinese / Cantonese were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral activation
Activity scheduling, monitoring, review and re-scheduling
Other:
Psychoeducation
Education on dementia, caregiving stress, event scheduling and communication skills

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Stanford University, The University of Hong Kong, United Christian Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive Symptoms Measured by CES-D Change from baseline through study completion, an average of about 5 months
Secondary Sense of Burden Measured by Zarit Burden Scale Change from baseline through study completion, an average of about 5 months
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