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Diabetes Mellitus, Type 2mDASNCT02990299

mHealth for Diabetes Adherence Support

A study testing mHealth for Diabetes Adherence Support in people with Diabetes Mellitus, Type 2, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to determine the benefit and cost of including health coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and videoconferencing in diabetes management support services for African-Americans and Latinos with uncontrolled Type 2 Diabetes. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
mHealth for Diabetes Adherence Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
1 siteUnited States
Study dates
24 Mar 2017to 7 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-identified as Latino/Hispanic or African-American
  • Verbal fluency in English or Spanish
  • Latest A1c ≥ 8.0% (within 3 mo)
  • History of Type 2 Diabetes (> 1 year)
  • Between the ages of 21 and 75 years
  • Unlimited mobile phone/text messaging plan with ability to reply to text messages
Show all 9Show fewer
  • Home environment capable of video conferencing with wireless signal
  • Receives primary care at UI Health clinical site for at least one year, with one visit during past year
  • Able and willing to provide informed consent (agree to data collection requirements, accept randomization, agree to home visitation with HC and pharmacist involvement, and participate for two years)

Who cannot join

  • Unable to verbalize comprehension of study or impaired decision making
  • Family/household member already participating in same study
  • Currently receiving regular pharmacist support through Medication Therapy Management or equivalent
  • History of, or planned, gastric bypass or transplant surgery
  • History of bipolar or psychotic disorder
  • Other severe comorbidities that require complex, aggressive, or palliative treatment, e.g., stage 4 or greater renal disease, liver failure, cancer (other than nonmelanoma skin cancer), terminal illness
  • Investigator discretion for safety concerns

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612

Other trials in United States

About this study

The purpose of this research study is to determine the benefit and cost of including health coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and videoconferencing in diabetes management support services for African-Americans and Latinos with uncontrolled Type 2 Diabetes.

Read the detailed description

Many African-Americans and Latinos with diabetes do not achieve recommended diabetes goals placing them at high risk for complications. Team-based models of care can help in reaching goals of therapy. Additionally, mobile health (mHealth) technologies can further improve outcomes among those more difficult to reach. This study will evaluate the impact of a team-based, mHealth intervention designed to improve medication adherence, healthy eating, and physical activity behaviors. The investigators will compare this mHealth approach with usual care.

Clinical pharmacists and health coaches (HC) will deliver our proposed team-based intervention. mHealth delivery includes mobile phone text messaging, secure videoconferencing, and HC home visits. Pharmacists will focus on medication reconciliation and adherence. Health coaches will help identify psychosocial and environmental challenges to adherence in a culturally-sensitive manner. Together, they can assist in goal-setting, problem-solving, negotiation of competing priorities, and provide social support leveraging mHealth technologies.

Preliminary data from previous research by the research team supports the role of health coaches partnering with clinic- based pharmacists in improving diabetes outcomes in minorities. In the proposed mHealth intervention, patient- pharmacist videoconferencing will eliminate the need for in-person visits with a pharmacist, which is impractical for many low-income patients. In addition, pilot work suggests that text messaging is a preferable means of communication and may facilitate more frequent contact with patients.

This is a randomized, controlled trial to evaluate the effectiveness of an mHealth diabetes adherence support intervention delivered by clinical pharmacists and health coaches. The research team will randomize 220 patients through UI Health to either: (1) mHealth diabetes adherence support through clinical pharmacists and health coaches; or (2) usual care. After one year, patients completing the mHealth intervention will be monitored for an additional year while the usual care group receives the mHealth approach. Outcomes include medication adherence, hemoglobin A1c, blood pressure, and LDL-cholesterol levels. The specific aims include: (1) evaluate the effectiveness of an mHealth diabetes adherence support intervention delivered by clinical pharmacists and health coaches to African-American and Latino adults with uncontrolled type 2 diabetes; (2) evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes one year after completing the intervention; (3) evaluate the cost and cost-effectiveness of mHealth diabetes adherence support compared to usual care; and (4) evaluate the reach, adoption, and implementation of mHealth diabetes adherence support based on the RE-AIM framework.

Being tested
mHealth for Diabetes Adherence Support
Keywords
Diabetes Mellitus, Type 2, Medication Adherence, Telemedicine, Community Health Workers, Pharmacists, Mobile Health
Medical subject headings
Diabetes Mellitus, Type 2, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth for Diabetes Adherence SupportBehavioural

    Also called mDAS

    Participants will be paired with a health coach who will provide ongoing support and resources in medication and lifestyle adherence and diabetes self-management. The health coach will perform regular home visits, telephone support and tailored text-messages based on the participant's preferences and needs. They will help assess barriers to adherence and use motivational interviewing to help patients set goals and create action plans. They will also facilitate videoconferences with an assigned clinical pharmacist who will provide consultation on medication use, reconciliation and adherence, identify therapeutic goals and formulate an approved plan of care.

Study groups in NCT02990299
Study groupRoleWhat they receive
Usual CareNo interventionParticipants will receive their usual care for the first year of their enrollment in the study. They will receive a referral to a diabetes educator and a clinical pharmacist, a one-page sheet of contact information for their healthcare providers, and paper-based, low-literacy diabetes information. After one year, they will change to the mDAS intervention arm for one year.
mHealth for Diabetes Adherence SupportExperimentalParticipants will receive in-person support from a health coach and a clinical pharmacist with whom they will meet with regularly via videoconference. After one year, participants who have completed the mDAS intervention will be monitored for an additional year with usual care to evaluate maintenance.
Receives: Behavioral: mHealth for Diabetes Adherence Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c

    Measured: 24 months

Secondary outcomes (11)

  1. Self-reported medication adherence

    A 3-item questionnaire will be administered to measure adherence to diabetes medications.

    Measured: 24 months

  2. Blood Pressure

    Measured: 24 months

  3. LDL Cholesterol

    LDL Cholesterol will be measured as part of a Full Lipid profile blood test.

    Measured: 24 months

  4. Diabetes Self-Management

    Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.

    Measured: 24 months

  5. Health related quality of life

    General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).

    Measured: 24 months

  6. Diabetes related quality of life

    Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).

    Measured: 24 months

  7. Depression

    Measured with the nine-item Patient Health Questionnaire (PHQ-9)

    Measured: 24 months

  8. Alcohol Misuse

    Measured using the 3-item AUDIT-C questionnaire

    Measured: 24 months

  9. BMI

    Height and weight will be taken at each time point to determine BMI

    Measured: 24 months

  10. Social Support

    4-item questionnaire measuring satisfaction with support from friends, family and health care team

    Measured: 24 months

  11. Diabetes Self-efficacy

    8 -item questionnaire measuring confidence in diabetes self-management skills

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study start24 Mar 2017
  3. Primary completion7 Jan 2022
  4. Study completion7 Jan 2022

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
A 2-arm, parallel, randomized controlled trial. Patients are randomized 1:1 to (1) mHealth diabetes adherence support intervention for one year and monitored with usual care for the second year, or (2) wait-list usual care for one year, then intervention during the second year.
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990299
Sponsor's protocol ID
2016-0380
Other IDs
1R01DK108141
Acronym
mDAS
Status last verified
Jun 2023
First submitted
5 Dec 2016
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharp LK, Biggers A, Perez R, Henkins J, Tilton J, Gerber BS. A Pharmacist and Health Coach-Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study. JMIR Res Protoc. 2021 Mar 10;10(3):e17170. doi: 10.2196/17170.

    PubMed 33688847

  • Gerber BS, Biggers A, Tilton JJ, Smith Marsh DE, Lane R, Mihailescu D, Lee J, Sharp LK. Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333629. doi: 10.1001/jamanetworkopen.2023.33629.

    PubMed 37773498

Questions about this trial

What is this clinical trial studying?

A study testing mHealth for Diabetes Adherence Support in people with Diabetes Mellitus, Type 2, run by University of Illinois Chicago 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 9 inclusion and 7 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 13 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hemoglobin A1c (time frame: 24 months). 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 NCT02990299, which also lists 2 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 13 Jun 2023.

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mHealth for Diabetes Adherence Support (NCT02990299) | AzTrials