- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03950973
Diabetes Outcomes and Unmet Resources
April 5, 2023 updated by: Minal Patel, University of Michigan
Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care.
Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be 18-75 years of age
- Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication
- Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age
- Have access to a telephone that can receive and send text messages
- Not participating in another diabetes intervention research study
Exclusion Criteria:
- Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CareAvenue
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
|
CareAvenue is an e-health tool providing information about diabetes management and low-cost resources.
Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Active Comparator: Guest Assistance Program
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
|
The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system.
Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c as measured by an HbA1c machine
Time Frame: Baseline, 6 months, 12 months
|
Change in HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine.
HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage.
|
Baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure as measured an automated blood pressure machine
Time Frame: Baseline, 6 months, 12 months
|
Change in blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine.
Blood pressure is measured as systolic blood pressure/diastolic blood pressure in millimeters of mercury (e.g., 120/80 mm Hg).
|
Baseline, 6 months, 12 months
|
Change in Cost-Related Non-Adherence Behaviors with prescribed treatment regimens related to diabetes as measured by participant questionnaire
Time Frame: Baseline, 6 months, 12 months
|
Cost-Related Non-Adherence (CRN) Behaviors related to diabetes will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at diabetes.
The items are measured with a 4-point Likert scale.
Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN.
|
Baseline, 6 months, 12 months
|
Change in Cost-Related Non-Adherence Behaviors with prescribed treatment regimens related to other conditions being managed as measured by participant questionnaire
Time Frame: Baseline, 6 months, 12 months
|
Cost-Related Non-Adherence (CRN) Behaviors related to other conditions being managed will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at other health conditions being managed.
The items are measured with a 4-point Likert scale.
Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN.
|
Baseline, 6 months, 12 months
|
Change in Perceived Financial Burden as measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)
Time Frame: Baseline, 6 months, 12 months
|
Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 12-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT).
The items are measured with a 5-point Likert scale.
The higher the score the better the Financial well-being.
|
Baseline, 6 months, 12 months
|
Change in Unmet Social Risk Factors as measured by participant questionnaire
Time Frame: Baseline, 6 months, 12 months
|
Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 20 items adapted from the Accountable Health Communities Health-Related Social Needs Screening Tool, the Health Leads Social Needs Screening Toolkit, and the Kaiser Permanente Your Current Life Situation Questionnaire.
The item values are binary (yes/no).
Number of "yes" responses indicates number of unmet social risk factors.
|
Baseline, 6 months, 12 months
|
Change in Unmet Social Risk Factors as measured by participant questionnaire
Time Frame: Baseline, 6 months, 12 months
|
Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 3 items from the Accountable Health Communities Health-Related Social Needs Screening Tool and 1 item adapted from the National Health Interview Survey.
The items each have three response options, in which a positive response indicates an unmet social risk factor.
|
Baseline, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Minal R Patel, PhD, MPH, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2019
Primary Completion (Actual)
March 28, 2023
Study Completion (Actual)
March 28, 2023
Study Registration Dates
First Submitted
May 13, 2019
First Submitted That Met QC Criteria
May 13, 2019
First Posted (Actual)
May 15, 2019
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00149794
- R01DK116715 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All of the individual participant data that underlie results in a publication, after de-identification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
The data will be made available to other researchers who provide a methodologically sound proposal and who have appropriate approvals from all relevant IRBs.
The data will be shared for analyses to achieve aims in the approved proposal.
Data will be shared through a secure FTP site through encryption protocols that allow secure uploading of files with data sharing limited to specific users.
Select datasets will also be made available through the University of Michigan openICPSR Repository (http://www.icpsr.umich.edu/icpsrweb/deposit/index.jsp).
Proposals should be directed to minalrp@umich.edu.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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