Trial Outcomes & Findings for Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam (NCT NCT03587974)

NCT ID: NCT03587974

Last Updated: 2020-07-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-07-22

Participant Flow

Participant milestones

Measure	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 REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Enhanced Control Single session with education about nature of dementia
Overall Study STARTED	30	30
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	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 REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease	Enhanced Control Single session with education about nature of dementia
Overall Study caregiver demented, care recipient died	3	3
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Data inadvertently not collected for two subjects.

Baseline characteristics by cohort

Measure	REACH-VN n=25 Participants 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	Enhanced Control n=26 Participants Single session with education about nature of dementia	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants • Data inadvertently not collected for two subjects.	0 Participants n=24 Participants • Data inadvertently not collected for two subjects.	0 Participants n=49 Participants • Data inadvertently not collected for two subjects.
Age, Categorical Between 18 and 65 years	17 Participants n=25 Participants • Data inadvertently not collected for two subjects.	15 Participants n=24 Participants • Data inadvertently not collected for two subjects.	32 Participants n=49 Participants • Data inadvertently not collected for two subjects.
Age, Categorical >=65 years	8 Participants n=25 Participants • Data inadvertently not collected for two subjects.	9 Participants n=24 Participants • Data inadvertently not collected for two subjects.	17 Participants n=49 Participants • Data inadvertently not collected for two subjects.
Age, Continuous	59 years STANDARD_DEVIATION 10.4 • n=25 Participants • Data inadvertently not collected for two subjects.	58.7 years STANDARD_DEVIATION 13.9 • n=24 Participants • Data inadvertently not collected for two subjects.	58.8 years STANDARD_DEVIATION 12.1 • n=49 Participants • Data inadvertently not collected for two subjects.
Sex: Female, Male Female	23 Participants n=25 Participants	21 Participants n=26 Participants	44 Participants n=51 Participants
Sex: Female, Male Male	2 Participants n=25 Participants	5 Participants n=26 Participants	7 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=25 Participants	26 Participants n=26 Participants	51 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Asian	25 Participants n=25 Participants	26 Participants n=26 Participants	51 Participants n=51 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) White	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Region of Enrollment Vietnam	25 participants n=25 Participants	26 participants n=26 Participants	51 participants n=51 Participants
Zarit Burden Inventory - 4 item	6.7 units on a scale STANDARD_DEVIATION 2.1 • n=25 Participants	6.8 units on a scale STANDARD_DEVIATION 2.3 • n=26 Participants	6.7 units on a scale STANDARD_DEVIATION 2.2 • n=51 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	REACH-VN n=25 Participants 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	Enhanced Control n=26 Participants Single session with education about nature of dementia
Zarit Burden Inventory-4	2.9 score on a scale Standard Deviation 2.4	5.5 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	REACH-VN n=25 Participants 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	Enhanced Control n=26 Participants Single session with education about nature of dementia
Patient Health Questionnaire-4	0.9 units on a scale Standard Deviation 1.0	2.9 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	REACH-VN n=25 Participants 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	Enhanced Control n=26 Participants Single session with education about nature of dementia
Alzheimer's Disease Knowledge Scale	19.9 score on a scale Standard Deviation 3.2	20.1 score on a scale Standard Deviation 2.0

Adverse Events

REACH-VN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ladson Hinton

UCaliforniaDavis

Phone: 9167343485

Email: lwhinton@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place