Trial Outcomes & Findings for Diabetes Homeless Medication Support Single Arm Treatment Development Trial (NCT NCT04678284)

Last Updated: 2023-04-18

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

Target enrollment

10 participants

Primary outcome timeframe

at 16 weeks

Results posted on

2023-04-18

Participant Flow

Initial phone screener = 27 In person screen = 23 Excluded = 13 A1c test \<7.5% (n = 2) Lost contact (n = 11)

Participant milestones

Participant milestones
Measure	D-Homes Intervention Behavioral treatments by a diabetes wellness coach as defined below. Diabetes Homeless Medication Support (D-Homes): 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 resource and care coordination. The coach will also provide brief diabetes education as needed.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes Homeless Medication Support Single Arm Treatment Development Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-Homes Intervention n=10 Participants Behavioral treatments by a diabetes wellness coach as defined below. Diabetes Homeless Medication Support (D-Homes): 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 resource and care coordination. The coach will also provide brief diabetes education as needed.
Age, Continuous	57.40 years STANDARD_DEVIATION 4.12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 16 weeks

Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	D-Homes Intervention n=10 Participants Behavioral treatments by a diabetes wellness coach as defined below. Diabetes Homeless Medication Support (D-Homes): 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 resource and care coordination. The coach will also provide brief diabetes education as needed.
Acceptability of Intervention	25.4 score on a scale Interval 17.5 to 33.3

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Change in point-of-care hemoglobin A1c: This test measures average blood sugar over a three month period, and smaller numbers indicate better glycemic control.

Outcome measures

Outcome measures
Measure	D-Homes Intervention n=10 Participants Behavioral treatments by a diabetes wellness coach as defined below. Diabetes Homeless Medication Support (D-Homes): 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 resource and care coordination. The coach will also provide brief diabetes education as needed.
Hemoglobin A1c	-0.5 percentage points Interval -1.8 to 0.9

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Change in psychological wellness as measured by the Short Form (SF)-12. The SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. Scores range from 20 to 60, and higher score indicate a higher level of functioning.

Outcome measures

Outcome measures
Measure	D-Homes Intervention n=10 Participants Behavioral treatments by a diabetes wellness coach as defined below. Diabetes Homeless Medication Support (D-Homes): 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 resource and care coordination. The coach will also provide brief diabetes education as needed.
Psychological Wellness	-2.6 score on a scale Interval -14.1 to 8.9

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Change in score on Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes.

Outcome measures

Outcome measures
Measure	D-Homes Intervention n=10 Participants Behavioral treatments by a diabetes wellness coach as defined below. Diabetes Homeless Medication Support (D-Homes): 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 resource and care coordination. The coach will also provide brief diabetes education as needed.
Diabetes Medication Adherence	0.6 score on a scale Interval -2.8 to 4.0

Adverse Events

D-Homes 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

Dr. Katherine Diaz Vickery

Hennepin Healthcare

Phone: 612-873-6852

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place