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Diabetes Outcomes and Unmet Resources

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ClinicalTrials.gov Identifier: NCT03950973
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Minal Patel, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: CareAvenue Behavioral: Guest Assistance Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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.
Behavioral: CareAvenue
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.
Behavioral: Guest Assistance Program
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950973


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Minal R Patel, PhD, MPH, BA University of Michigan

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Responsible Party: Minal Patel, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03950973     History of Changes
Other Study ID Numbers: HUM00149794
R01DK116715 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data that underlie results in a publication, after de-identification.
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Minal Patel, University of Michigan:
Diabetes
Self-management
Adherence
Social determinants of health
Social risk factors
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases