Effectiveness Study of Interactive Web Application for Problem Solving in Diabetes Management

This study is not yet open for participant recruitment.
Verified December 2013 by Columbia University
Sponsor:
Collaborators:
Clinical Directors Network
Georgia Institute of Technology
Information provided by (Responsible Party):
Olena Mamykina, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT02021591
First received: December 18, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: Early Mobile Diabetes Detective (MoDD)
Behavioral: Late Mobile Diabetes Detective (MoDD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial of Health Information Technology for Problem Solving in Diabetes Management

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in HgA1c [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

  • Change in Score on the Diabetes Problem-Solving Inventory (DPSI) [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Diabetes Problem-Solving Inventory (DPSI) is a 9-item questionnaire that assesses individuals' problem-solving skills as applied specifically to overcoming barriers to diabetes self-management.

  • Change in Score on the Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) contains 12 items with 5 subscales (diet, exercise, blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week he/she performed the behavior; higher scores indicate higher performance.


Secondary Outcome Measures:
  • Change in Score on Problem Areas in Diabetes Scale (PAID) [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Problem Areas in Diabetes Scale (PAID) is a 20 item 5 point Likert scale that measures the emotional aspect of living with diabetes .

  • Change in Score on the Diabetes Self-Efficacy Scale (DSES) [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Diabetes Self-Efficacy Scale (DSES) is 15-item 10-point Likert scale (1-cannot do at all; 10-Certain can do) that measures the belief that one can self-manage one's own health, specifically adapted to diabetes.

  • Change in Score on the Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Patient Health Questionnaire-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day").

  • Change in Fasting Blood Glucose Level [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Fasting blood glucose will be collected from patients' charts.

  • Change in Total Cholesterol [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Blood Pressure [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Blood pressure will be collected using patients' charts.

  • Change in High-Density Lipoprotein [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Low-Density Lipoprotein [ Time Frame: Baseline, post-intervention 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: December 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Late Intervention (LI)
Control Arm: Study participants attending one of the 4 Late Intervention (LI) centers will receive usual diabetes education provided by staff at the site; be provided with free test strips for their blood glucose meters during the 4-week intervention period; given access to the MODD application at the end of the study. Instructions on how to use the MODD will be provided by site staff.
Behavioral: Late Mobile Diabetes Detective (MoDD)

Study participants will be given access to the MODD application at the end of the study. Instructions on how to use the MODD will be provided by site staff.

MoDD is a web-based application that is designed to help individuals with diabetes identify specific problems related to glycemic control, and engage in problem-solving process. MoDD includes a number of messages that explain its users the nature of various problems related to glycemic control, aspects of individuals' behaviors that might have contributed to these problems, and alternative behaviors that could help to improve glycemic control. In addition to these messages displayed on the MoDD website, study participants may receive SMS messages with reminders to test blood glucose, or to follow the selected new behavior.

Experimental: Early Intervention (EI)
Experimental Arm: Mobile Diabetes Detective (MoDD) Study participants attending one of the 4 Early Intervention sites (EI) will receive usual diabetes education provided by staff at the site and be given access to the MODD application and instructions for use for 4 weeks at the beginning of the study. After the initial 4 weeks of access to the MODD application, participants will be offered an option to continue using MODD for the duration of the study.
Behavioral: Early Mobile Diabetes Detective (MoDD)

Study participants will be given access to the MODD application and instructions for use for 4 weeks at the beginning of the study. After the initial 4 weeks of access to the MODD application, participants will be offered an option to continue using MODD for the duration of the study.

MoDD is a web-based application that is designed to help individuals with diabetes identify specific problems related to glycemic control, and engage in problem-solving process. MoDD includes a number of messages that explain its users the nature of various problems related to glycemic control, aspects of individuals' behaviors that might have contributed to these problems, and alternative behaviors that could help to improve glycemic control. In addition to these messages displayed on the MoDD website, study participants may receive SMS messages with reminders to test blood glucose, or to follow the selected new behavior.


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02021591

Contacts
Contact: Andrea Cassells, MpH 212-382-0699 ext 227 acass@cdnetwork.org

Locations
United States, New York
Clinical Directors Network Not yet recruiting
New York, New York, United States, 10018
Sub-Investigator: Andrea Cassells, MPH         
Principal Investigator: Jonathan Tobin, PhD         
Sponsors and Collaborators
Columbia University
Clinical Directors Network
Georgia Institute of Technology
Investigators
Principal Investigator: Olena Mamykina, PhD Columbia University
Study Chair: Jonathan Tobin, PhD Clinical Directors Network
  More Information

Publications:

Responsible Party: Olena Mamykina, PhD, Assistant Professor, Biomedical Informatics, Columbia University
ClinicalTrials.gov Identifier: NCT02021591     History of Changes
Other Study ID Numbers: AAAM0057, 1R01DK090372-01A1
Study First Received: December 18, 2013
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Diabetes
Chronic disease
problem solving
self management

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014