Trial Outcomes & Findings for Caregiving While Black: LIVE (NCT NCT06605391)
NCT ID: NCT06605391
Last Updated: 2025-09-23
Results Overview
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Feeling understood and supported by healthcare providers" has 4 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses and ranges from 1 to 4. Higher scores indicate that the subscale is an area of health literacy strength.
COMPLETED
NA
40 participants
Baseline, Month 3, Month 6
2025-09-23
Participant Flow
Participants were enrolled through Emory University in Atlanta, Georgia, USA. Participant enrollment began October 1, 2024 and all follow-up assessments were completed by August 12, 2025.
Participant milestones
| Measure |
Caregiving While Black-LIVE
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
Caregiving While Black-LIVE: Caregiving While Black-LIVE is a psychoeducation program that aims to intensify the development of caregiver mastery by integrating the online learning assets of the fully asynchronous Caregiving While Black program with synchronous, group-based opportunities for interactivity and active learning. The Caregiving While Black course includes topics of navigating the healthcare system, managing home life, and caregiver self-care. Once enrolled in the course, participants will be provided instructions for accessing the weekly sessions and course online, and supplemental course materials will be mailed to them. The Canvas platform enables the research team to monitor each individual's movement in the cohort through the asynchronous part of the course. Nudges and reminders to view these materials are sent twice a week via text or email with participant's consent. Synchronous sessions are conducted on a videoconferencing platform.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
Completed the Assessment at Month 3
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36
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caregiving While Black: LIVE
Baseline characteristics by cohort
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Age, Continuous
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56.60 years
STANDARD_DEVIATION 9.75 • n=93 Participants
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Sex/Gender, Customized
Female
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34 Participants
n=93 Participants
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Sex/Gender, Customized
Male
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5 Participants
n=93 Participants
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Sex/Gender, Customized
Non-binary
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1 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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37 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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40 Participants
n=93 Participants
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Race (NIH/OMB)
White
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0 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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40 Participants
n=93 Participants
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Relation to person living with dementia who is being cared for
Spouse
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5 Participants
n=93 Participants
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Relation to person living with dementia who is being cared for
Parent
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29 Participants
n=93 Participants
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Relation to person living with dementia who is being cared for
Other relative
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6 Participants
n=93 Participants
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Living with person living with dementia
No
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21 Participants
n=93 Participants
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Living with person living with dementia
Yes
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19 Participants
n=93 Participants
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Employed outside of the home
No
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15 Participants
n=93 Participants
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Employed outside of the home
Yes
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25 Participants
n=93 Participants
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Education
High school/General Educational Development (GED)
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1 Participants
n=93 Participants
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Education
Some college
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8 Participants
n=93 Participants
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Education
College graduate
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22 Participants
n=93 Participants
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Education
Graduate degree
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9 Participants
n=93 Participants
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|
Marriage status
Single
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13 Participants
n=93 Participants
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Marriage status
Married
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20 Participants
n=93 Participants
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Marriage status
Divorced or separated
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4 Participants
n=93 Participants
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Marriage status
Widowed
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3 Participants
n=93 Participants
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Annual income
$0 - $30,000
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7 Participants
n=93 Participants
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Annual income
$31,000 - $60,000
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10 Participants
n=93 Participants
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|
Annual income
$61,000 - $90,000
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6 Participants
n=93 Participants
|
|
Annual income
$91,000 - $120,000
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9 Participants
n=93 Participants
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Annual income
More than $120,000
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4 Participants
n=93 Participants
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Annual income
Do not wish to answer
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4 Participants
n=93 Participants
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Area of residence
Urban
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14 Participants
n=93 Participants
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Area of residence
Suburban
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22 Participants
n=93 Participants
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Area of residence
Rural
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4 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Feeling understood and supported by healthcare providers" has 4 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses and ranges from 1 to 4. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Health Literacy Questionnaire (HLQ) Score for Feeling Understood by Healthcare Providers Subscale
Month 3
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2.9 score on a scale
Standard Deviation 0.69
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Health Literacy Questionnaire (HLQ) Score for Feeling Understood by Healthcare Providers Subscale
Month 6
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3.0 score on a scale
Standard Deviation 0.61
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Health Literacy Questionnaire (HLQ) Score for Feeling Understood by Healthcare Providers Subscale
Baseline
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3.0 score on a scale
Standard Deviation 0.71
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Appraisal of health information" has 5 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses and ranges from 1 to 4. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Health Literacy Questionnaire (HLQ) Score for Appraisal of Health Information Subscale
Baseline
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3.1 score on a scale
Standard Deviation 0.61
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Health Literacy Questionnaire (HLQ) Score for Appraisal of Health Information Subscale
Month 3
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3.2 score on a scale
Standard Deviation 0.55
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Health Literacy Questionnaire (HLQ) Score for Appraisal of Health Information Subscale
Month 6
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3.1 score on a scale
Standard Deviation 0.37
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Ability to actively engage with healthcare providers" has 5 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Health Literacy Questionnaire (HLQ) Score for Ability to Engage With Healthcare Providers Subscale
Baseline
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3.9 score on a scale
Standard Deviation 0.62
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Health Literacy Questionnaire (HLQ) Score for Ability to Engage With Healthcare Providers Subscale
Month 3
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4.0 score on a scale
Standard Deviation 0.64
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Health Literacy Questionnaire (HLQ) Score for Ability to Engage With Healthcare Providers Subscale
Month 6
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4.1 score on a scale
Standard Deviation 0.51
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Navigating the healthcare system" has 6 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Health Literacy Questionnaire (HLQ) Score for Navigating the Healthcare System Subscale
Baseline
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3.5 score on a scale
Standard Deviation 0.62
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Health Literacy Questionnaire (HLQ) Score for Navigating the Healthcare System Subscale
Month 3
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3.7 score on a scale
Standard Deviation 0.51
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Health Literacy Questionnaire (HLQ) Score for Navigating the Healthcare System Subscale
Month 6
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3.7 score on a scale
Standard Deviation 0.49
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Ability to find good health information" has 5 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Health Literacy Questionnaire (HLQ) Score for Ability to Find Information Subscale
Baseline
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3.8 score on a scale
Standard Deviation 0.57
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Health Literacy Questionnaire (HLQ) Score for Ability to Find Information Subscale
Month 3
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3.8 score on a scale
Standard Deviation 0.39
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Health Literacy Questionnaire (HLQ) Score for Ability to Find Information Subscale
Month 6
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4.0 score on a scale
Standard Deviation 0.47
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Understand health information well enough to know what to do" has 5 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Health Literacy Questionnaire (HLQ) Score for Understand Health Information Subscale
Baseline
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4.0 score on a scale
Standard Deviation 0.50
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Health Literacy Questionnaire (HLQ) Score for Understand Health Information Subscale
Month 3
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4.0 score on a scale
Standard Deviation 0.41
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Health Literacy Questionnaire (HLQ) Score for Understand Health Information Subscale
Month 6
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4.1 score on a scale
Standard Deviation 0.52
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Zarit Burden Inventory (ZBI) Score
Baseline
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34.2 score on a scale
Standard Deviation 15.44
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Zarit Burden Inventory (ZBI) Score
Month 3
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31.0 score on a scale
Standard Deviation 11.95
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Zarit Burden Inventory (ZBI) Score
Month 6
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29.8 score on a scale
Standard Deviation 11.03
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 60 with higher scores indicating greater symptoms of depression.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Center for Epidemiological Studies - Depression Score
Baseline
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11.8 score on a scale
Standard Deviation 8.94
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Center for Epidemiological Studies - Depression Score
Month 3
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10.8 score on a scale
Standard Deviation 8.39
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Center for Epidemiological Studies - Depression Score
Month 6
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8.6 score on a scale
Standard Deviation 7.78
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Perceived Stress Scale Score
Baseline
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24.8 score on a scale
Standard Deviation 8.18
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Perceived Stress Scale Score
Month 3
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23.0 score on a scale
Standard Deviation 7.35
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Perceived Stress Scale Score
Month 6
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22.6 score on a scale
Standard Deviation 6.05
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points. Two participants did not complete this assessment at the Baseline visit.
The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=38 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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State-Trait Anxiety Inventory (STAI) Score
Baseline
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39.2 score on a scale
Standard Deviation 12.30
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State-Trait Anxiety Inventory (STAI) Score
Month 3
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36.2 score on a scale
Standard Deviation 8.70
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State-Trait Anxiety Inventory (STAI) Score
Month 6
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35.8 score on a scale
Standard Deviation 7.92
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points.
The Caregiver Assessment of Behavioral Skill instrument includes 17 items asking how frequently caregivers respond to certain situations. Responses are given on a 3-point scale where "seldom true" is scored as 0 and "true most of the time" is scored as 2 (a response is also available when the situation is not relevant). The total score is is the sum of item ratings and ranges from 0 to 34, where higher scores indicate greater behavioral skills as related to caregiving.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Caregiver Assessment of Behavioral Skill Score
Baseline
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14.3 score on a scale
Standard Deviation 5.33
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Caregiver Assessment of Behavioral Skill Score
Month 3
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14.4 score on a scale
Standard Deviation 4.57
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Caregiver Assessment of Behavioral Skill Score
Month 6
|
14.9 score on a scale
Standard Deviation 5.97
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PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants who completed study assessment at the indicated time points. One participant did not complete this assessment at the Month 3 time point.
Self-rated caregiving competency is assessed with 4 items asking about feelings the caregiver has as a result of providing care. Responses are given on a 4-point scale where "not at all" is scored as 1 and "completely" or "very" is scored as 4. The total score ranges from 4 to 16 with higher scores indicating greater feelings of competency.
Outcome measures
| Measure |
Caregiving While Black-LIVE
n=40 Participants
Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.
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|---|---|
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Pearlin Competence and Management of Situation Score
Baseline
|
11.8 score on a scale
Standard Deviation 2.40
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Pearlin Competence and Management of Situation Score
Month 3
|
13.4 score on a scale
Standard Deviation 2.03
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Pearlin Competence and Management of Situation Score
Month 6
|
13.5 score on a scale
Standard Deviation 2.05
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Social support for health" has 5 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Actively managing my health" has 5 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Having sufficient information to manage my health" has 4 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses. Higher scores indicate that the subscale is an area of health literacy strength.
Outcome measures
Outcome data not reported
Adverse Events
Caregiving While Black-LIVE
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