Efficacy Study of Interactive Web Application for Problem Solving in Diabetes Management
NCT ID: NCT02021591
Last Updated: 2018-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2013-12-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Control Arm: Study participants attending one of the 4 control arm 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.
No interventions assigned to this group
Intervention
Intervention: Mobile Diabetes Detective (MoDD) Study participants attending one of the 4 Intervention sites 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.
Mobile Diabetes Detective (MoDD)
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.
Interventions
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Mobile Diabetes Detective (MoDD)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Clinical Directors Network
NETWORK
Georgia Institute of Technology
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Columbia University
OTHER
Responsible Party
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Olena Mamykina, PhD
Assistant Professor, Biomedical Informatics
Principal Investigators
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Olena Mamykina, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Jonathan Tobin, PhD
Role: STUDY_CHAIR
Clinical Directors Network
Locations
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Clinical Directors Network
New York, New York, United States
Countries
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References
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Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.
Paterson B, Thorne S. Expert decision making in relation to unanticipated blood glucose levels. Res Nurs Health. 2000 Apr;23(2):147-57. doi: 10.1002/(sici)1098-240x(200004)23:23.0.co;2-s.
Bonnet C, Gagnayre R, d'Ivernois JF. Learning difficulties of diabetic patients: a survey of educators. Patient Educ Couns. 1998 Oct;35(2):139-47. doi: 10.1016/s0738-3991(98)00051-2.
Cook S, Aikens JE, Berry CA, McNabb WL. Development of the diabetes problem-solving measure for adolescents. Diabetes Educ. 2001 Nov-Dec;27(6):865-74. doi: 10.1177/014572170102700612.
Glasgow RE, Toobert DJ, Riddle M, Donnelly J, Mitchell DL, Calder D. Diabetes-specific social learning variables and self-care behaviors among persons with type II diabetes. Health Psychol. 1989;8(3):285-303. doi: 10.1037//0278-6133.8.3.285.
Toobert DJ, Glasgow RE. Problem solving and diabetes self-care. J Behav Med. 1991 Feb;14(1):71-86. doi: 10.1007/BF00844769.
Costa BM, Fitzgerald KJ, Jones KM, Dunning Am T. Effectiveness of IT-based diabetes management interventions: a review of the literature. BMC Fam Pract. 2009 Nov 17;10:72. doi: 10.1186/1471-2296-10-72.
Glasgow RE, Funnell MM, Bonomi AE, Davis C, Beckham V, Wagner EH. Self-management aspects of the improving chronic illness care breakthrough series: implementation with diabetes and heart failure teams. Ann Behav Med. 2002 Spring;24(2):80-7. doi: 10.1207/S15324796ABM2402_04.
Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based approach. Am J Prev Med. 2002 May;22(4):267-84. doi: 10.1016/s0749-3797(02)00415-4.
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.
Other Identifiers
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AAAM0057
Identifier Type: -
Identifier Source: org_study_id
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