Take Charge of Your Diabetes

Not Applicable

Completed

• Conditions: Diabetes; Hypertension

• Registration Number: NCT01977495
• Lead Sponsor: University of Pennsylvania

Brief Summary

The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Adults between 18 and 80 years of age
2. Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania
3. Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years
4. A confirmed diabetes diagnosis
5. Planning to stay in area for study duration (6 months)
6. Can understand and communicate fluently in English

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Exclusion Criteria

1. Unable to read and give consent
2. Suffer from an uncontrolled psychiatric disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment and participation rates	End of study- 6 months after enrollment	The primary objective is to obtain preliminary evidence regarding whether or not patients opt-into a research study, as opposed to enrolling by default, will affect participation in the program and the effectiveness of the intervention, among high-risk patients. The primary outcome is to measure enrollment rates. The investigators will also measure participation in the program through device usage.

Secondary Outcome Measures

Name	Time	Method
Uptake of Device Usage	End of study- 6 months after enrollment	Assess the effect of financial incentives on the use of home health monitoring devices among high-risk patients

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States