Trial Outcomes & Findings for VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers (NCT NCT02106065)

Last Updated: 2021-08-13

Results Overview

The Zarit Burden Inventory is a self-report measure of caregiver burden. Higher scores on this assessment indicate greater levels of caregiver burden. Potential scores range from 0-88 with higher scores indicating more severe burden.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

change from baseline at 6-months post intervention

Results posted on

2021-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	ESBR-i Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	ESBR-v Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	Usual Care Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Overall Study STARTED	6	11	15
Overall Study 6 Month Completion	3	8	5
Overall Study COMPLETED	3	8	5
Overall Study NOT COMPLETED	3	3	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ESBR-i n=6 Participants Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	ESBR-v n=11 Participants Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	Usual Care n=15 Participants Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.	Total n=32 Participants Total of all reporting groups
Age, Continuous	71.0 years STANDARD_DEVIATION 7.0 • n=5 Participants	69.8 years STANDARD_DEVIATION 10.7 • n=7 Participants	65 years STANDARD_DEVIATION 10.9 • n=5 Participants	68.6 years STANDARD_DEVIATION 9.53 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Zarit Burden Inventory	50.0 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants	30.6 units on a scale STANDARD_DEVIATION 12.5 • n=7 Participants	40.8 units on a scale STANDARD_DEVIATION 12.0 • n=5 Participants	40.47 units on a scale STANDARD_DEVIATION 9.9 • n=4 Participants

PRIMARY outcome

Timeframe: change from baseline at 6-months post intervention

Outcome measures

Outcome measures
Measure	ESBR-i n=3 Participants Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	ESBR-v n=8 Participants Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	Usual Care n=5 Participants Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Zarit Burden Inventory	2.0 score on a scale Standard Deviation 2.6	-0.4 score on a scale Standard Deviation 5.0	1.6 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: change from baseline at 6-months

change in caregiver depressive symptoms as measured by the Center for Epidemiological Studies-Depression (CES-D). Scores on the CES-D can range from 0-60 with higher scores suggesting greater depressive symptomatology.

Outcome measures

Outcome measures
Measure	ESBR-i n=3 Participants Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	ESBR-v n=8 Participants Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	Usual Care n=5 Participants Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Center for Epidemiological Studies-Depression	2.0 score on a scale Standard Deviation 6.9	0.1 score on a scale Standard Deviation 3.3	-0.2 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 6-months post intervention

Population: This data was not collected thus is not reported here.

Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6-months post intervention

Based on caregiver interview, care recipient mortality status will be ascertained

Outcome measures

Outcome measures
Measure	ESBR-i n=3 Participants Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	ESBR-v n=8 Participants Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	Usual Care n=5 Participants Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Change in All-cause Mortality Status (Care Recipient)	1 Participants	0 Participants	1 Participants

Adverse Events

ESBR-i

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

ESBR-v

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ESBR-i n=6 participants at risk Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	ESBR-v n=11 participants at risk Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.	Usual Care n=15 participants at risk Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Musculoskeletal and connective tissue disorders Musculoskeletal injury	0.00% 0/6 • 24 Months	0.00% 0/11 • 24 Months	6.7% 1/15 • 24 Months

Additional Information

Dr. Kaci Fairchild

VA Palo Alto Health Care System

Phone: 6504935000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place