Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03587974
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.

Condition or Disease	Intervention/Treatment	Phase
Family Caregivers	Behavioral: REACH-VIETNAM	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster randomized controlled trialCluster randomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
• Actual Study Start Date: Jun 10, 2018
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REACH-VN In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months	Behavioral: REACH-VIETNAM; Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease
No Intervention: Enhanced control Single session with education about nature of dementia

Outcome Measures

Primary Outcome Measures

1. Zarit Burden Inventory-4 [3 months]

   Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden).

Secondary Outcome Measures

1. Patient Health Questionnaire-4 [3 months]

   Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity).

2. Alzheimer's Disease Knowledge Scale [3 months]

   Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Family member providing care to someone in household with Alzheimer's disease or a related dementia

Exclusion Criteria:

• Cognitively impaired

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vietnam National Geriatric Hospital	Hanoi		Vietnam

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Ladson Hinton, MD, UC Davis

Study Documents (Full-Text)

• Informed Consent Form - Apr 2, 2018
• Statistical Analysis Plan - Mar 1, 2020
• Study Protocol - Apr 2, 2018

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03587974
• Other Study ID Numbers: 1223433
• First Posted: Jul 16, 2018
• Last Update Posted: Jul 22, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	REACH-VN	Enhanced Control
Arm/Group Description	In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Single session with education about nature of dementia
Period Title: Overall Study
STARTED	30	30
COMPLETED	25	26
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	REACH-VN	Enhanced Control	Total
Arm/Group Description	In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Single session with education about nature of dementia	Total of all reporting groups
Overall Participants	25	26	51
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 68%	15 57.7%	32 62.7%
>=65 years	8 32%	9 34.6%	17 33.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (10.4)	58.7 (13.9)	58.8 (12.1)
Sex: Female, Male (Count of Participants)
Female	23 92%	21 80.8%	44 86.3%
Male	2 8%	5 19.2%	7 13.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	25 100%	26 100%	51 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	25 100%	26 100%	51 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Vietnam	25 100%	26 100%	51 100%
Zarit Burden Inventory - 4 item (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.7 (2.1)	6.8 (2.3)	6.7 (2.2)

Outcome Measures

1. Primary Outcome

Title	Zarit Burden Inventory-4
Description	Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REACH-VN	Enhanced Control
Arm/Group Description	In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Single session with education about nature of dementia
Measure Participants	25	26
Mean (Standard Deviation) [score on a scale]	2.9 (2.4)	5.5 (3.4)

2. Secondary Outcome

Title	Patient Health Questionnaire-4
Description	Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REACH-VN	Enhanced Control
Arm/Group Description	In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Single session with education about nature of dementia
Measure Participants	25	26
Mean (Standard Deviation) [units on a scale]	0.9 (1.0)	2.9 (2.8)

3. Secondary Outcome

Title	Alzheimer's Disease Knowledge Scale
Description	Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REACH-VN	Enhanced Control
Arm/Group Description	In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Single session with education about nature of dementia
Measure Participants	25	26
Mean (Standard Deviation) [score on a scale]	19.9 (3.2)	20.1 (2.0)

Adverse Events

Time Frame	For each participant adverse events were collected for the duration of participation in the study (i.e., up to 3 months)
Arm/Group Title	REACH-VN		Enhanced Control
Arm/Group Description	In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease		Single session with education about nature of dementia
All Cause Mortality
	REACH-VN		Enhanced Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	REACH-VN		Enhanced Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	REACH-VN		Enhanced Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.