Diabetes Mellitus, Type 2
Conditions
Keywords
Unstably Housed Persons, Hispanic or Latino, Homelessness
Brief summary
This single-arm trial of the Diabetes Homeless Medication Support intervention for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.
Detailed description
This study has an overall goal to modify and pilot test a previously developed 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). The intervention was developed in English. This study is intended to test the modified intervention for DH who speak Spanish (DH-SH). The study 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-SH. This protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the D-Homes treatment manual through test cases (n=12). The study team hypothesizes that the D-Homes manual and study procedures will be feasible and acceptable to DH-SH as measured by self-report and post-treatment interview.
Interventions
BEHAVIORALDiabetes 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.
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 use behavioral activation and motivational interviewing 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
* Age 18 yrs or older * Spanish-speaking * Recent homelessness by federal definition (HEARTH ACT) 1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent) 2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation) * Self-reported diagnosis of type 2 diabetes, later verified in medical record * Plan to stay in local area or be reachable by phone for the next 16 weeks * Willingness to work on medication adherence and diabetes self-care
Exclusion criteria
* Inability to provide informed consent (e.g. presence of a legal guardian, prisoners) * Active psychosis or intoxication precluding ability to give informed consent * Pregnant or lactating females * 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 |
|---|---|---|
| Change in Glycemic Control | Baseline and 16 weeks | We 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. |
| Health-related Quality of Life | Baseline and 16 weeks | As 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. |
| Diabetes Medication Adherence | Baseline and 16 weeks | As 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. |
Countries
United States
Participant flow
Pre-assignment details
Initial phone screener = 23 In person screening = 21 Excluded after in person screening = 9 for reason A1c below 7.5
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | DH-Spanish Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
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) | Dispersion |
|---|---|---|---|
| DH-Spanish Intervention | Acceptability of Intervention | 30.5 score on a scale | Standard Deviation 0.34 |
Secondary
Change in Glycemic Control
We 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.
Time frame: Baseline and 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DH-Spanish Intervention | Change in Glycemic Control | Baseline | 9.1 percentage of HbA1c | Standard Deviation 1 |
| DH-Spanish Intervention | Change in Glycemic Control | 16 weeks | 8.2 percentage of HbA1c | Standard Deviation 1.6 |
Secondary
Diabetes Medication Adherence
As 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.
Time frame: Baseline and 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DH-Spanish Intervention | Diabetes Medication Adherence | Baseline | 14.6 score on a scale | Standard Deviation 4.3 |
| DH-Spanish Intervention | Diabetes Medication Adherence | 16 weeks | 14.2 score on a scale | Standard Deviation 4.9 |
Secondary
Health-related Quality of Life
As 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.
Time frame: Baseline and 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DH-Spanish Intervention | Health-related Quality of Life | Baseline - PCS12 | 41.2 score on a scale | Standard Deviation 7.3 |
| DH-Spanish Intervention | Health-related Quality of Life | 16 weeks - PCS12 | 39.7 score on a scale | Standard Deviation 7 |
| DH-Spanish Intervention | Health-related Quality of Life | Baseline - MCS12 | 46.4 score on a scale | Standard Deviation 7.7 |
| DH-Spanish Intervention | Health-related Quality of Life | 16 weeks - MCS12 | 49.7 score on a scale | Standard Deviation 9.1 |