Completed
D-HOMES

Diabetes Homeless Medication Support

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What is being tested

Diabetes Homeless Medication Support (D-Homes)

+ Enhanced usual care
Behavioral
Who is being recruted

Diabetes Mellitus, Type 2

+ Housing Problems
+ Psychological Distress
Over 18 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2022

See protocol details

Summary

Principal SponsorHennepin Healthcare Research Institute
Last updated: November 7, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: February 23, 2022Actual date on which the first participant was enrolled.

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. 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.

Official TitleDiabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes) 
Principal SponsorHennepin Healthcare Research Institute
Last updated: November 7, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
38 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diabetes Mellitus, Type 2
Housing Problems
Psychological Distress
Criteria
6 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Behavioral treatments by a diabetes wellness coach as defined below.
Group II
Active Comparator
Brief diabetes educational session by a diabetes wellness coach.
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

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.

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Hennepin HealthcareMinneapolis, United StatesSee the location
CompletedOne Study Center