Diabetes Mellitus, Type 2DH-SpanishNCT05819749
Diabetes Homelessness Medication Support Program in Spanish
A study testing Diabetes Homelessness Medication Support Program in Spanish in people with Diabetes Mellitus, Type 2, 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 for Spanish-speaking people (n=12) 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
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Homelessness Medication Support Program in Spanish
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 12 Jul 2024
- 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
- Spanish-speaking
- Recent homelessness by federal definition (HEARTH ACT)
- Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
- 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
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
Official title: Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes Homelessness Medication Support Program in Spanish
- Keywords
- Unstably Housed Persons, Hispanic or Latino, Homelessness
- 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 Homelessness Medication Support Program in SpanishBehavioural
Also called DH-Spanish, DHomes - 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.
| Study group | Role | What they receive |
|---|---|---|
| DH-Spanish Intervention | Experimental | Behavioral treatment by a diabetes wellness coach. Receives: Behavioral: Diabetes Homelessness Medication Support Program in Spanish |
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)
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.
Measured: Baseline and 16 weeks
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.
Measured: Baseline and 16 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. We will compare ARMS-D scores from baseline to 16 weeks.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023
- Primary completion22 Feb 2024
- Study completion12 Jul 2024
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 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 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 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.
- Masking
- None (open label)
- Enrolment
- 12 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
- Investigators
- Katherine D Vickery, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819749
- Sponsor's protocol ID
- IRB-FY2023-556
- Other IDs
- R03DK133553
- Acronym
- DH-Spanish
- Status last verified
- Sep 2024
- First submitted
- 6 Apr 2023
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayberry 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 24209600Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. doi: 10.1023/a:1008809610703.
PubMed 9523497Nguyen 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 10267258
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics
- ClinicalTrials.gov ID
- NCT05819749
- Acronym / sponsor ID
- DH-Spanish / IRB-FY2023-556
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Unstably Housed Persons, Hispanic or Latino, Homelessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 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
- 1 May 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Posted 9 Oct 2024
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 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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| DH-Spanish Intervention | Experimental | Behavioral: Diabetes Homelessness Medication Support Program in SpanishBehavioral treatment 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 (8 listed)
- Age 18 yrs or older
- Spanish-speaking
- Recent homelessness by federal definition (HEARTH ACT)
- 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 Homelessness Medication Support Program in SpanishAlso: DH-Spanish, DHomes - SpanishThere 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. | Behavioural | DH-Spanish 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
Change in Glycemic Control
Time frame: Baseline and 16 weeks
Health-related Quality of Life
Time frame: Baseline and 16 weeks
Diabetes Medication Adherence
Time frame: Baseline and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Background: PubMed 9523497Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. doi: 10.1023/a:1008809610703.
- 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.
- Individual participant dataSharing planned: No
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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 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 study testing Diabetes Homelessness Medication Support Program in Spanish in people with Diabetes Mellitus, Type 2, 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 8 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 9 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 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?
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 NCT05819749, 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 9 Oct 2024.