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

NCT02021591 | Completed DMC

• 2 other identifiers: AAAM00571R01DK090372-01A1
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes; Chronic disease; problem solving; self management

Outcome Measures

Primary Outcomes (3)

• Change in HgA1c

  Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

  Baseline, post-intervention 4 weeks, 3 months, 12 months

• Change in Score on the Diabetes Problem-Solving Inventory (DPSI)

  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.

  Baseline, post-intervention 4 weeks, 3 months, 12 months

• Change in Score on the Summary of Diabetes Self-Care Activities Questionnaire (SDSCA)

  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.

  Baseline, post-intervention 4 weeks, 3 months, 12 months

Secondary Outcomes (8)

• Change in Score on Problem Areas in Diabetes Scale (PAID)

  Baseline, post-intervention 4 weeks, 3 months, 12 months

• Change in Score on the Diabetes Self-Efficacy Scale (DSES)

  Baseline, post-intervention 4 weeks, 3 months, 12 months

• Change in Score on the Patient Health Questionnaire-2 (PHQ-2)

  Baseline, post-intervention 4 weeks, 3 months, 12 months

• Change in Fasting Blood Glucose Level

  Baseline, post-intervention 4 weeks, 3 months, 12 months

• Change in Total Cholesterol

  Baseline, post-intervention 4 weeks, 3 months, 12 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Behavioral: Mobile Diabetes Detective (MoDD)

Interventions

Mobile Diabetes Detective (MoDD) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Clinical Directors Network: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Georgia Institute of Technology: collaborator

Study Sites (1)

Clinical Directors Network

New York, New York, 10018, United States

Location

Related Publications (10)

• 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.

  PMID: 12763713 BACKGROUND

• 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.

  PMID: 10782873 BACKGROUND

• 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.

  PMID: 10026556 BACKGROUND

• 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.

  PMID: 12211926 BACKGROUND

• 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.

  PMID: 2767020 BACKGROUND

• Toobert DJ, Glasgow RE. Problem solving and diabetes self-care. J Behav Med. 1991 Feb;14(1):71-86. doi: 10.1007/BF00844769.

  PMID: 2038046 BACKGROUND

• 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.

  PMID: 19917136 BACKGROUND

• 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.

  PMID: 12054323 BACKGROUND

• 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.

  PMID: 11988383 BACKGROUND

• 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.

  PMID: 29059017 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olena Mamykina, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Jonathan Tobin, PhD

  Clinical Directors Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Biomedical Informatics

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 27, 2013
• Study Start: December 30, 2013
• Primary Completion: February 3, 2017
• Study Completion: March 31, 2017
• Last Updated: March 2, 2026

Record last verified: 2018-03

Locations

US (1)