Homeless Persons, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health
Brief summary
This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.
Detailed description
This study is of a set of studies with an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). Our team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH. This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the D-Homes treatment manual through test cases (n=15). With a hypothesis that the D-Homes manual and study procedures will be feasible and acceptable to DH as measured by self-report and post-treatment interview.
Interventions
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.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota
Hennepin Healthcare Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be an in-person, phone, or video based behavioral intervention. It will involve a diabetes wellness coach assisting participants to set goals related to diabetes self-care and co-morbidities or social conditions that get in the way of diabetes self-care. There will be encouragement to work on diabetes medication adherence and to address any un/under-treated behavioral health conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 yrs. or older 2. English-speaking 3. Homelessness by federal definition in the last 12 mo. 4. Self-reported diagnosis of type 2 diabetes, later verified in medical record 5. Plan to stay in local area or be reachable by phone for the next 16 weeks 6. Willingness to work on medication adherence and diabetes self-care 7. HbA1c \>/= 7.5%
Exclusion criteria
1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners) 2. Active psychosis or intoxication precluding ability to give informed consent 3. Pregnant or lactating females. 4. Patients who choose to opt out of research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | at 16 weeks | Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 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. |
| Psychological Wellness | 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. |
| Diabetes Medication Adherence | 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. |
Countries
United States
Participant flow
Pre-assignment details
Initial phone screener = 27 In person screen = 23 Excluded = 13 A1c test \<7.5% (n = 2) Lost contact (n = 11)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | D-Homes Intervention |
|---|---|
| Age, Continuous | 57.40 years STANDARD_DEVIATION 4.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Acceptability of Intervention
Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Time frame: at 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| D-Homes Intervention | Acceptability of Intervention | 25.4 score on a scale |
Secondary
Diabetes Medication Adherence
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| D-Homes Intervention | Diabetes Medication Adherence | 0.6 score on a scale |
Secondary
Hemoglobin A1c
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.
Time frame: Baseline to 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| D-Homes Intervention | Hemoglobin A1c | -0.5 percentage points |
Secondary
Psychological Wellness
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.
Time frame: Baseline to 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| D-Homes Intervention | Psychological Wellness | -2.6 score on a scale |