Take Charge of Your Diabetes

Hypertension Clinical Trial

Official title:

Testing Enrollment Methods on Participation in Behavioral Economic Interventions for Diabetes Care: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977495
• Other study ID #: 818810
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: December 7, 2015
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion Criteria:

1. Unable to read and give consent

2. Suffer from an uncontrolled psychiatric disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Behavioral:
• Financial Incentive: Fixed Lottery
Every day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hemoglobin A1c	Assess how regular use of home-based health monitoring devices affects clinical outcomes, such as Hemoglobin A1C	End of study- 6 months after enrollment	No
Primary	Enrollment and participation rates	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.	End of study- 6 months after enrollment	No
Secondary	Uptake of Device Usage	Assess the effect of financial incentives on the use of home health monitoring devices among high-risk patients	End of study- 6 months after enrollment	No