Trial Outcomes & Findings for Mobile Tablet Education to Advance Caregiver Health (NCT NCT03417219)
NCT ID: NCT03417219
Last Updated: 2019-07-15
Results Overview
The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?." Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline, 4 month follow-up
Results posted on
2019-07-15
Participant Flow
Participant milestones
| Measure |
Mobile Media Education and Skill-Building Rehabilitation Int
The investigators' ESBR-m intervention consists of four, 90-minute group (\<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
|
Usual Care
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Mobile Media Education and Skill-Building Rehabilitation Int
The investigators' ESBR-m intervention consists of four, 90-minute group (\<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
|
Usual Care
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Mobile Tablet Education to Advance Caregiver Health
Baseline characteristics by cohort
| Measure |
Mobile Media Education and Skill-Building Rehabilitation Int
n=8 Participants
The investigators' ESBR-m intervention consists of four, 90-minute group (\<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
|
Usual Care
n=8 Participants
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
61.12 years
STANDARD_DEVIATION 7.54 • n=7 Participants
|
66.06 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 month follow-upThe Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?." Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome.
Outcome measures
| Measure |
Mobile Media Education and Skill-Building Rehabilitation Int
n=8 Participants
The investigators' ESBR-m intervention consists of four, 90-minute group (\<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
|
Usual Care
n=5 Participants
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
|
|---|---|---|
|
Change From Baseline Zarit Burden Interview (ZBI) at 4 Months
|
-2.25 score on a scale
Standard Deviation 7.80
|
0.80 score on a scale
Standard Deviation 13.48
|
PRIMARY outcome
Timeframe: Baseline, 4 month follow-upThe Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period. The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention. Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded. Total scores are calculated by summing all responses and range from 0-60. A higher score is indicative of a worse outcome.
Outcome measures
| Measure |
Mobile Media Education and Skill-Building Rehabilitation Int
n=8 Participants
The investigators' ESBR-m intervention consists of four, 90-minute group (\<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
|
Usual Care
n=5 Participants
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
|
|---|---|---|
|
Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months
|
-3.00 score on a scale
Standard Deviation 4.54
|
1.60 score on a scale
Standard Deviation 4.83
|
PRIMARY outcome
Timeframe: Baseline, 4 month follow-upThe Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56. Lower values indicate lower perceived stress while higher values indicate higher perceived stress.
Outcome measures
| Measure |
Mobile Media Education and Skill-Building Rehabilitation Int
n=8 Participants
The investigators' ESBR-m intervention consists of four, 90-minute group (\<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
|
Usual Care
n=5 Participants
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
|
|---|---|---|
|
Change From Baseline Perceived Stress Scale (PSS) at 4 Months
|
-1.00 score on a scale
Standard Deviation 9.34
|
3.40 score on a scale
Standard Deviation 4.93
|
Adverse Events
Mobile Media Education and Skill-Building Rehabilitation Int
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place