Clinical trial NCT02021591: Efficacy Study of Interactive Web Application for Problem Solving in Diabetes Management
Official title: Randomized Clinical Trial of Health Information Technology for Problem Solving in Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Chronic disease
problem solving
self management
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Clinical Directors Network
name: Georgia Institute of Technology
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-12-27
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main hypothesis of this research is that use of an informatics intervention for problem-solving in diabetes management, Mobile Diabetes Detective (MoDD), by individuals with type 2 diabetes will lead to positive improvements on a number of primary and secondary outcomes related to their health and their management of diabetes. The primary outcomes are a reduction in individuals' glycolated hemoglobin (HbA1c), improvement in their problem-solving abilities, and self-care behaviors. Secondary outcomes include a reduction in individuals' fasting blood glucose (BG); improvement in individuals' self-efficacy, and in emotional aspect of living with diabetes. We hypothesize that primary and secondary outcome effects will be sustained at three months and twelve months. Exploratory outcomes include a decrease in individuals' Cardiovascular Risk (Body Mass Index, Blood Pressure, Total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) Cholesterol levels, and Framingham Cardiovascular Risk Score). We also hypothesize that improvements in clinical outcomes (HbA1c, fasting BG and Cardiovascular Risk) will be mediated by the improvements in problem-solving abilities and self-efficacy.

Detailed description: Well-developed problem-solving is essential to successful diabetes management results in better diabetes self-care behaviors, and leads to improvements in clinical outcomes. Problem-solving is central to many self-management and behavior change programs; the American Diabetes Association (ADA) includes problem-solving as a critical self-care behavior. Given the importance of problem solving skills, innovative diabetes education programs, such as Discovering Diabetes, have been developed and shown to be effective in fostering independent problem-solving.

At the same time, many care management programs and diabetes education centers struggle with staffing shortages, limited funding, and competitive time demands. As a result, 50 to 80% of individuals with diabetes experience significant knowledge and skill deficits. Health Information Technology (HIT) can make successful interventions available to more diverse populations. At present, however, many HIT interventions target improved patient-clinician communication and logging and monitoring, rather than focusing more specifically on fostering problem-solving skills. Moreover, few HIT interventions have been rigorously evaluated in controlled trials. The main contribution of this research is a theoretically-grounded HIT intervention, Mobile Diabetes Detective (MoDD), that incorporates best practices and current guidelines for supporting and fostering individuals' problem-solving skills in context of diabetes self-management. In our prior work we developed and evaluated a mobile application for reflection and discovery in diabetes management, MAHI (Mobile Access to Health Information). MAHI helped individuals with diabetes capture diabetes-related experiences and reflect on them under a supervision of a diabetes educator. The proposed intervention, MoDD will further extend this prior work, specifically focusing on guided problem-solving through experimentation. The intervention will utilize an open source platform for disease self-management developed by the research team.

If the results are achieved, the project will have significant impact both locally and globally. Locally, diabetes continues to be a major problem in NYC, particularly among disadvantaged populations, many of whom are served by the Health Resources and Services Administration (HRSA) funded Community Health Centers (CHCs) participating in this study. In the past 10 years, the number of people with diabetes in NYC has more than doubled. An estimated 530,000 adult New Yorkers have been diagnosed with diabetes, with another 265,000 having diabetes but are unaware. In the HRSA funded CHCs in New York State, 8% of the adult patients have a diagnosis of diabetes. At the same time, our prior studies showed that despite such barriers as low health literacy or lower socio-economic status, disadvantaged populations in NYC can greatly benefit from informatics interventions that target health and wellness. The proposed research will use HIT to partially assuage the ongoing challenge of control and management of diabetes. The expected improvement in problem-solving skills has been shown to lead to improved self-care behaviors, such as a more careful diet and appropriate level of exercise, and significant reduction in HbA1c7, which in turn has been linked to reduction in diabetes-related complications. Thinking more broadly, this research can provide new insights into facilitating problem-solving in diabetes management with HIT, as an alternative to more traditional staff-intensive interventions.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* A diagnosis of Type 2 Diabetes with HbA1c ≥ 8.0. A patient of the health center for at least 6 months
* Has participated in at least one diabetes education session at the participating site in the last 6 months
* Proficient in either English or Spanish
* Must own a basic cell phone

Exclusion Criteria:

* Pregnancy
* Presence of serious illness (e.g. cancer diagnosis with active treatment, advanced stage heart failure, multiple sclerosis)
* Presence of cognitive impairment
* Plans for leaving the community health center (CHC) in the next 12 months
* Does not have a computer and/or Internet access

Primary outcomes:
measure: Change in HgA1c
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Score on the Diabetes Problem-Solving Inventory (DPSI)
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Score on the Summary of Diabetes Self-Care Activities Questionnaire (SDSCA)
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
Secondary outcomes:
measure: Change in Score on Problem Areas in Diabetes Scale (PAID)
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Score on the Diabetes Self-Efficacy Scale (DSES)
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Score on the Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Fasting Blood Glucose Level
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Total Cholesterol
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Blood Pressure
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in High-Density Lipoprotein
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
measure: Change in Low-Density Lipoprotein
timeFrame: Baseline, post-intervention 4 weeks, 3 months, 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical Directors Network
state: New York
Study officials:
affiliation: Columbia University
name: Olena Mamykina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network
name: Jonathan Tobin, PhD
role: STUDY_CHAIR
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citation: Heitkemper EM, Mamykina L, Tobin JN, Cassells A, Smaldone A. Baseline Characteristics and Technology Training of Underserved Adults With Type 2 Diabetes in the Mobile Diabetes Detective (MoDD) Randomized Controlled Trial. Diabetes Educ. 2017 Dec;43(6):576-588. doi: 10.1177/0145721717737367. Epub 2017 Oct 23.