mHealth for Diabetes Adherence Support
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 10/28/2018 |
| Start Date: | March 24, 2017 |
| End Date: | June 2021 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
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