Trial Outcomes & Findings for Building a Bridge (BAB) Between Clinical and Community Care (NCT NCT03932812)
NCT ID: NCT03932812
Last Updated: 2022-12-16
Results Overview
Caregiver burden 12 item self report questionnaire; Minimum score 0, maximum score 36 with low scores showing less burden
COMPLETED
NA
82 participants
Change over time from baseline to 6-month
2022-12-16
Participant Flow
Participant milestones
| Measure |
Options Counselor Health Educator Intervention Group
These individuals will receive the Options Counselor Health Educator Intervention
Options Counselor Health Educator (OC-HE) Intervention: The OC-HE will meet in person with the participant one time and five times via telephone to provide options counseling based on modules developed by the research team
|
Control
These individuals will receive the typical standard of care treatment from clinics
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
|
Overall Study
Baseline Interview
|
42
|
40
|
|
Overall Study
3 Month Survey
|
29
|
26
|
|
Overall Study
6 Month Survey
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Options Counselor Health Educator Intervention Group
These individuals will receive the Options Counselor Health Educator Intervention
Options Counselor Health Educator (OC-HE) Intervention: The OC-HE will meet in person with the participant one time and five times via telephone to provide options counseling based on modules developed by the research team
|
Control
These individuals will receive the typical standard of care treatment from clinics
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
14
|
|
Overall Study
Death of care partner (person living with dementia)
|
5
|
1
|
Baseline Characteristics
Building a Bridge (BAB) Between Clinical and Community Care
Baseline characteristics by cohort
| Measure |
Options Counselor Health Educator Intervention Group
n=42 Participants
These individuals will receive the Options Counselor Health Educator Intervention
Options Counselor Health Educator (OC-HE) Intervention: The OC-HE will meet in person with the participant one time and five times via telephone to provide options counseling based on modules developed by the research team
|
Control
n=40 Participants
These individuals will receive the typical standard of care treatment from clinics
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
FAST Score
|
2.5 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 13.3 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 13.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change over time from baseline to 6-monthPopulation: All participants who completed baseline. Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
Caregiver burden 12 item self report questionnaire; Minimum score 0, maximum score 36 with low scores showing less burden
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=42 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=40 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Modified Zarit Burden Interview
Baseline
|
19.429 Burden score
Standard Deviation 9.399
|
17.950 Burden score
Standard Deviation 8.348
|
|
Modified Zarit Burden Interview
3-month
|
32.207 Burden score
Standard Deviation 7.466
|
27.160 Burden score
Standard Deviation 6.811
|
|
Modified Zarit Burden Interview
6-month
|
31.375 Burden score
Standard Deviation 6.864
|
28.615 Burden score
Standard Deviation 8.208
|
SECONDARY outcome
Timeframe: Change over time from baseline to 6-monthPopulation: Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
Established measure of the extent to which caregiver knows about formal services available in their communities. Participants answer the extent to which (on a five-point Likert scale from "not at all true of me" to "completely true of me") they are informed about federal programs, that they know what to do to get help, that they know how to get the person they care for into a nursing home, that they are aware of how to pay for a nursing home, that they can get information about different options for getting care, that they know which home health care agencies are active in their area, that they know which nursing facilities are available in their area, and how to get assistance due to COVID (added later). The scale ranges from "Not True at all of me" to "Completely true of me", where these answers and those in between score 1-5. The scale is scored by adding up these scores of the 8 questions. Thus, the range is 8-40, with a 40 being the highest knowledge of formal services.
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=42 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=40 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Knowledge of Formal Services
Baseline
|
25.381 score on a scale
Standard Deviation 8.704
|
25.350 score on a scale
Standard Deviation 8.678
|
|
Knowledge of Formal Services
3-month
|
29.690 score on a scale
Standard Deviation 7.607
|
28.154 score on a scale
Standard Deviation 7.953
|
|
Knowledge of Formal Services
6-month
|
29.520 score on a scale
Standard Deviation 9.315
|
28.222 score on a scale
Standard Deviation 7.567
|
SECONDARY outcome
Timeframe: Change over time from baseline to 6-monthPopulation: Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
Ten item measure assessing the extent to which the individual is experiencing depressive symptoms. Questions ask about how often feelings or events happen in a week on a scale from None of the time, where less than one day receives 0 points, to Most of the time, where 5 to 7 days receives 3 points. The lowest score is a 0, indicating no depression. The highest score is 30, indicating high depression.
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=39 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=36 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Center for Epidemiologic Studies Depression
Baseline
|
4.051 score on a scale
Standard Deviation 4.751
|
2.806 score on a scale
Standard Deviation 3.710
|
|
Center for Epidemiologic Studies Depression
3-month
|
19.517 score on a scale
Standard Deviation 7.740
|
19.640 score on a scale
Standard Deviation 7.804
|
|
Center for Epidemiologic Studies Depression
6-month
|
7.240 score on a scale
Standard Deviation 6.741
|
5.815 score on a scale
Standard Deviation 4.261
|
SECONDARY outcome
Timeframe: Change over time from baseline to 6-monthPopulation: Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
Self-reported measure of the number of times participants have visited a doctor or other health care provider unexpectedly in the past 6 months. The lowest score could be 0, indicating no emergency care use and the highest score for each could be 180 days, indicating that the participant visited a doctor or health care provider every day for the past six months
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=42 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=40 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Emergency Care Use
Baseline
|
0.714 Visits
Standard Deviation 1.255
|
0.750 Visits
Standard Deviation 1.296
|
|
Emergency Care Use
3-months
|
0.207 Visits
Standard Deviation 0.491
|
0.320 Visits
Standard Deviation 0.476
|
|
Emergency Care Use
6-months
|
0.292 Visits
Standard Deviation 0.908
|
0.346 Visits
Standard Deviation 0.562
|
SECONDARY outcome
Timeframe: Change over time from baseline to 6-monthPopulation: Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
Count of network members engaging in supportive interactions (Uplift) for each caregiver. Each caregiver had network members providing different levels of support. There are 8 survey questions to indicate whether network members engaged in uplifting interactions in any way. A network member with at least one interaction is counted. At each time point, the questions are asked again and reevaluated.
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=41 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=40 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Social Network-Uplift
Baseline
|
11.439 Count of support network members for a c
Standard Deviation 6.786
|
10.750 Count of support network members for a c
Standard Deviation 5.088
|
|
Social Network-Uplift
3-month
|
8.448 Count of support network members for a c
Standard Deviation 5.494
|
12.400 Count of support network members for a c
Standard Deviation 5.331
|
|
Social Network-Uplift
6-month
|
7.880 Count of support network members for a c
Standard Deviation 5.102
|
9.889 Count of support network members for a c
Standard Deviation 5.423
|
SECONDARY outcome
Timeframe: Change over time from baseline to 6-monthPopulation: Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
Count of network members engaging in negative caregiving social interactions (Malfeasant) for each caregiver. Each caregiver had network members providing different levels of support. There are 7 survey questions to indicate whether network members engaged in malfeasant interactions in any way. A network member with at least one interaction is counted. At each time point, the questions are asked again and reevaluated.
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=41 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=40 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Social Network-Malfeasant
6-month
|
1.520 Count of support network members for a c
Standard Deviation 1.418
|
0.852 Count of support network members for a c
Standard Deviation 1.027
|
|
Social Network-Malfeasant
Baseline
|
2.098 Count of support network members for a c
Standard Deviation 2.035
|
1.800 Count of support network members for a c
Standard Deviation 1.436
|
|
Social Network-Malfeasant
3-month
|
4.966 Count of support network members for a c
Standard Deviation 4.395
|
8.360 Count of support network members for a c
Standard Deviation 5.992
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over time from baseline to 6-monthPopulation: Note that the discrepancies in the number analyzed at different time points are due to patients dropping out of the study.
5-item self-reported measure assessing caregivers' confidence to use community-based services. The scale ranges on level of certainty from "not at all certain" to "very certain." The responses are scored on a scale of 0-10. These scores are summed up for a final score of 0-50, with a 50 being the highest knowledge of formal services. Questions include how certain the caregiver can get answers to all questions about services in the community, find organizations or agencies that provide services in need, arrange for services themselves, get answers to all questions about the individual's care, and get answers to changes in services due to the COVID-19 pandemic.
Outcome measures
| Measure |
Options Counselor Health Educator Intervention Group
n=42 Participants
These individuals received the Options Counselor Health Educator (OC-HE) Intervention: The OC-HE met in person or over the telephone with the participant up to 6 times to provide options counseling based on modules developed by the research team.
|
Control
n=40 Participants
These individuals received the typical standard of care treatment from clinics
|
|---|---|---|
|
Caregiving Self-Efficacy
Baseline
|
29.524 score on a scale
Standard Deviation 12.814
|
31.775 score on a scale
Standard Deviation 10.666
|
|
Caregiving Self-Efficacy
3-month
|
35.345 score on a scale
Standard Deviation 12.995
|
34.600 score on a scale
Standard Deviation 10.528
|
|
Caregiving Self-Efficacy
6-month
|
33.667 score on a scale
Standard Deviation 13.157
|
33.481 score on a scale
Standard Deviation 7.992
|
Adverse Events
Options Counselor Health Educator Intervention Group
Control
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