CompletedNot Applicable

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

United States248 participantsStarted 2013-12-30

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in HgA1c

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

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

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

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

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

Trial details

NCT IDNCT02021591

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-03

View on ClinicalTrials.gov More Diabetes Mellitus trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in HgA1c

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

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

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

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

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