Type 2 DiabetesD-HomesNCT04678284
Diabetes Homeless Medication Support Single Arm Treatment Development Trial
A study testing Diabetes Homeless Medication Support (D-Homes) in people with Type 2 Diabetes and Homeless Persons, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Homeless Persons
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 24 Mar 2022
- Phase
- Interventional
- 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 in the last 12 mo.
- 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
- HbA1c >/= 7.5%
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 females.
- Patients who choose to opt out of research.
Trial locations and contacts
1 site in 1 country.
About this study
This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.
Read the 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.
- Conditions
- Type 2 Diabetes, Homeless Persons
- Being tested
- Diabetes Homeless Medication Support (D-Homes)
- Keywords
- Type 2 Diabetes, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health
- 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 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.
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Measured: at 16 weeks
Secondary outcomes (3)
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start24 Mar 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678284
- Sponsor's protocol ID
- HHRI-DHomes
- Other IDs
- K23DK118117
- Acronym
- D-Homes
- Status last verified
- Apr 2023
- First submitted
- 17 Dec 2020
- Last updated
- 18 Apr 2023
- 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 will inform treatment development, we will not share individual participant data. We will submit for publication an overall paper describing our results and how they informed future intervention development.
Publications
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.
PubMed 10267258EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
PubMed 24209600
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Homeless Medication Support Single Arm Treatment Development Trial
- ClinicalTrials.gov ID
- NCT04678284
- Acronym / sponsor ID
- D-Homes / HHRI-DHomes
- Conditions
- Type 2 Diabetes, Homeless Persons
- Keywords
- Type 2 Diabetes, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| D-Homes intervention | Experimental | Behavioral: Diabetes Homeless Medication Support (D-Homes)Behavioral treatments by a diabetes wellness coach as defined below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 yrs. or older
- English-speaking
- Homelessness by federal definition in the last 12 mo.
- 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
Key exclusion criteria (4 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 females.
- Patients who choose to opt out of research.
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 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. | Behavioural | D-Homes intervention |
Primary outcome
Acceptability of Intervention
Time frame: at 16 weeks
Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
3 secondary outcomes
Hemoglobin A1c
Time frame: Baseline to 16 weeks
Psychological Wellness
Time frame: Baseline to 16 weeks
Diabetes Medication Adherence
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10267258Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.
- Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- Background: PubMed 24209600Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
- Individual participant dataSharing planned: No. As this work will inform treatment development, we will not share individual participant data. We 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Homeless Medication Support (D-Homes) in people with Type 2 Diabetes and Homeless Persons, 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 7 inclusion and 4 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 18 Apr 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). 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?
Acceptability of Intervention (time frame: at 16 weeks). 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 NCT04678284, which also lists 3 linked publications.
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 18 Apr 2023.