Take Charge of Your Diabetes

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01977495

Collaborator

National Institute on Aging (NIA) (NIH)

136

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Hypertension	Behavioral: Financial Incentive: Fixed Lottery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Opt-in Enrollment Opt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit.	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.
Active Comparator: Opt-out enrollment Opt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit.	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.

Arm

Intervention/Treatment

Active Comparator: Opt-in Enrollment

Opt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit.

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.

Active Comparator: Opt-out enrollment

Opt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit.

Behavioral: Financial Incentive: Fixed Lottery

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Change in Hemoglobin A1c [End of study- 6 months after enrollment]
Assess how regular use of home-based health monitoring devices affects clinical outcomes, such as Hemoglobin A1C

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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