Diabetes Mellitus, Type 2Phase 2D-HOMESNCT05258630
Diabetes Homeless Medication Support
A Phase 2 study testing Diabetes Homeless Medication Support (D-Homes) in people with Diabetes Mellitus, Type 2 and Housing Problems, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Housing Problems, Psychological Distress
- What is being tested?
- Diabetes Homeless Medication Support (D-Homes)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 12 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 yrs. or older
- English-speaking
- Homelessness by federal definition (HEARTH ACT) in the past 24 mos.
- Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study point-of-care lab test.
- Plan to stay in local area or be reachable by phone for the next 24 weeks
- Willingness to work on medication adherence and diabetes self-care
Who cannot join
- 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 people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)
This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.
Read the detailed description
This study has 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). The investigators' 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 study will involve addition of a randomization schema to compare D-Homes to brief diabetes education. The study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. This includes an assessment of sustained impact of the program at 24-weeks post-treatment. These will complement 12-week post-treatment primary outcome measures.
- Being tested
- Diabetes Homeless Medication Support (D-Homes), Enhanced usual care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Homeless Medication Support (D-Homes)Behavioural
There will be 10 sessions offered within 12 weeks to participants. Sessions will last approximately 30 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 a tailored tool to the patient's needs/goals and tailored diabetes education as needed.
Enhanced usual careBehavioural
Trained diabetes wellness coaches will provide an approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will read these with participants and answer basic questions. Handouts will cover (1) general diabetes knowledge, (2) healthy eating with diabetes, (3) physical activity with diabetes. The coach will also provide a general tool to support medication adherence (e.g. pillbox).
| Study group | Role | What they receive |
|---|---|---|
| D-Homes intervention | Experimental | Behavioral treatments by a diabetes wellness coach as defined below. Receives: Behavioral: Diabetes Homeless Medication Support (D-Homes); Behavioral: Enhanced usual care |
| Enhanced usual care | Active comparator | Brief diabetes educational session by a diabetes wellness coach. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience During the Intervention
The acceptability of the intervention to participants will be measured by the Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Measured: Assessed at 16 weeks
Retention in Assessments
The study team will track enrolled participants who complete both post-treatment assessment visits (12-16 week post-treatment assessment and 24-30 week assessment). Retention will be measured as the percentage of enrolled participants who complete both assessments as assessed at 30 weeks.
Measured: Assessed at 30 weeks
Secondary outcomes (3)
Change in Glycemic Control
The study team will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using fingerstick blood samples. The study team will compare glycemic control from baseline to 16 weeks and from baseline to 30 weeks.
Measured: Assessed at Baseline, 16 weeks, and 30 weeks.
Psychological Wellness
Psychological wellness is measured with the 5-item Mental Health Inventory (MHI-5), a brief transdiagnostic screening tool attuned to broader concepts of wellbeing and distress than other available measures. MHI-5 scores are computed and transformed on a 0 to 100 point scale with higher scores indicating more wellness. We compare MHI-5 scores from baseline to 16 weeks and from baseline to 30 weeks.
Measured: Assessed at baseline, 16 weeks, and 30 weeks
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. The study team will compare ARMS-D scores from baseline to 16 weeks and baseline to 30 weeks.
Measured: Assessed at Baseline, 16 weeks, and 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start23 Feb 2022
- Primary completion27 Apr 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study team will use 1 to 1 allocation to intervention vs. comparison arms. They will stratify based on more and less stable housing in the 12 mo. prior to enrollment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine D Vickery, MD, MSc, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258630
- Sponsor's protocol ID
- IRB-FY2021-317
- Other IDs
- K23DK118117
- Acronym
- D-HOMES
- Status last verified
- Nov 2024
- First submitted
- 17 Feb 2022
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this work is pilot data to inform treatment development for later efficacy testing, we will not share individual participant data. The study team will submit for publication an overall paper describing our results and how they informed future intervention development.
Publications
Vickery KD, Gelberg L, Hyson AR, Strother E, Carter J, Oranday Perez O, Franco M, Kavistan S, Gust S, Adair E, Anderson-Campbell A, Brito L, Butler A, Robinson T, Connett J, Evans MD, Emmons KM, Comulada WS, Busch AM. Pilot trial results of D-HOMES: a behavioral-activation based intervention for diabetes medication adherence and psychological wellness among people who have been homeless. Front Psychiatry. 2024 Feb 29;15:1329138. doi: 10.3389/fpsyt.2024.1329138. eCollection 2024.
PubMed 38487573
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)
- ClinicalTrials.gov ID
- NCT05258630
- Acronym / sponsor ID
- D-HOMES / IRB-FY2021-317
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.
Detailed description
This study has 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). The investigators' 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 study will involve addition of a randomization schema to compare D-Homes to brief diabetes education. The study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. This includes an assessment of sustained impact of the program at 24-weeks post-treatment. These will complement 12-week post-treatment primary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study team will use 1 to 1 allocation to intervention vs. comparison arms. They will stratify based on more and less stable housing in the 12 mo. prior to enrollment.
| Arm | Type | Receives |
|---|---|---|
| D-Homes intervention | Experimental | Behavioral: Diabetes Homeless Medication Support (D-Homes), Behavioral: Enhanced usual careBehavioral treatments by a diabetes wellness coach as defined below. |
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual careBrief diabetes educational session by a diabetes wellness coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 yrs. or older
- English-speaking
- Homelessness by federal definition (HEARTH ACT) in the past 24 mos.
- Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study point-of-care lab test.
- Plan to stay in local area or be reachable by phone for the next 24 weeks
Key exclusion criteria (3 listed)
- 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 people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Homeless Medication Support (D-Homes)There will be 10 sessions offered within 12 weeks to participants. Sessions will last approximately 30 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 a tailored tool to the patient's needs/goals and tailored diabetes education as needed. | Behavioural | D-Homes intervention |
| Enhanced usual careTrained diabetes wellness coaches will provide an approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will read these with participants and answer basic questions. Handouts will cover (1) general diabetes knowledge, (2) healthy eating with diabetes, (3) physical activity with diabetes. The coach will also provide a general tool to support medication adherence (e.g. pillbox). | Behavioural | D-Homes intervention, Enhanced usual care |
Primary outcome
Experience During the Intervention
Time frame: Assessed at 16 weeks
The acceptability of the intervention to participants will be measured by the Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Retention in Assessments
Time frame: Assessed at 30 weeks
The study team will track enrolled participants who complete both post-treatment assessment visits (12-16 week post-treatment assessment and 24-30 week assessment). Retention will be measured as the percentage of enrolled participants who complete both assessments as assessed at 30 weeks.
3 secondary outcomes
Change in Glycemic Control
Time frame: Assessed at Baseline, 16 weeks, and 30 weeks.
Psychological Wellness
Time frame: Assessed at baseline, 16 weeks, and 30 weeks
Diabetes Medication Adherence
Time frame: Assessed at Baseline, 16 weeks, and 30 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38487573Vickery KD, Gelberg L, Hyson AR, Strother E, Carter J, Oranday Perez O, Franco M, Kavistan S, Gust S, Adair E, Anderson-Campbell A, Brito L, Butler A, Robinson T, Connett J, Evans MD, Emmons KM, Comulada WS, Busch AM. Pilot trial results of D-HOMES: a behavioral-activation based intervention for diabetes medication adherence and psychological wellness among people who have been homeless. Front Psychiatry. 2024 Feb 29;15:1329138. doi: 10.3389/fpsyt.2024.1329138. eCollection 2024.
- Individual participant dataSharing planned: No. As this work is pilot data to inform treatment development for later efficacy testing, we will not share individual participant data. The study team will submit for publication an overall paper describing our results and how they informed future intervention development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine D Vickery, MD, MSc principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diabetes Homeless Medication Support (D-Homes) in people with Diabetes Mellitus, Type 2 and Housing Problems, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience During the Intervention (time frame: Assessed at 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.