Trial Outcomes & Findings for Diabetes Homelessness Medication Support Program in Spanish (NCT NCT05819749)
NCT ID: NCT05819749
Last Updated: 2024-10-09
Results Overview
Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
at 16 weeks
Results posted on
2024-10-09
Participant Flow
Initial phone screener = 23 In person screening = 21 Excluded after in person screening = 9 for reason A1c below 7.5
Participant milestones
| Measure |
DH-Spanish Intervention
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Overall Study
STARTED
|
12
|
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Overall Study
COMPLETED
|
11
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DH-Spanish Intervention
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Diabetes Homelessness Medication Support Program in Spanish
Baseline characteristics by cohort
| Measure |
DH-Spanish Intervention
n=12 Participants
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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12 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 16 weeksClient Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Outcome measures
| Measure |
DH-Spanish Intervention
n=11 Participants
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Acceptability of Intervention
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30.5 score on a scale
Standard Deviation 0.34
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SECONDARY outcome
Timeframe: Baseline and 16 weeksWe will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using blood samples collected via venipuncture. We will compare glycemic control from baseline to 16 weeks.
Outcome measures
| Measure |
DH-Spanish Intervention
n=11 Participants
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Change in Glycemic Control
Baseline
|
9.1 percentage of HbA1c
Standard Deviation 1
|
|
Change in Glycemic Control
16 weeks
|
8.2 percentage of HbA1c
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline and 16 weeksAs measured by the 12 Item Short Form Survey (SF-12), a 12-question questionnaire. The SF-12 is analyzed for two summary scores - the physical component score (PCS-12) and the mental component score (MCS-12). The average score of each component is 50 for people in the United States, with a standard deviation of 10 points. Scores above 50 indicate higher than average health-related quality of life while scores below 50 indicate lower than average health-related quality of life.
Outcome measures
| Measure |
DH-Spanish Intervention
n=11 Participants
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Health-related Quality of Life
Baseline - PCS12
|
41.2 score on a scale
Standard Deviation 7.3
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Health-related Quality of Life
16 weeks - PCS12
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39.7 score on a scale
Standard Deviation 7.0
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Health-related Quality of Life
Baseline - MCS12
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46.4 score on a scale
Standard Deviation 7.7
|
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Health-related Quality of Life
16 weeks - MCS12
|
49.7 score on a scale
Standard Deviation 9.1
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SECONDARY outcome
Timeframe: Baseline and 16 weeksAs measured by the Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes. We will compare ARMS-D scores from baseline to 16 weeks.
Outcome measures
| Measure |
DH-Spanish Intervention
n=11 Participants
Behavioral treatment by a diabetes wellness coach.
Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed.
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|---|---|
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Diabetes Medication Adherence
Baseline
|
14.6 score on a scale
Standard Deviation 4.3
|
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Diabetes Medication Adherence
16 weeks
|
14.2 score on a scale
Standard Deviation 4.9
|
Adverse Events
DH-Spanish Intervention
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
Katherine Diaz Vickery
Hennepin Healthcare Research Institute
Phone: 612-873-6852
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place