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Take Charge of Your Diabetes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977495
Enrollment
136
Registered
2013-11-06
Start date
2013-12-31
Completion date
2014-08-31
Last updated
2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension

Keywords

Diabetes, Enrollment methods, Behavioral Economic Intervention, Opt-in Enrollment, Opt-out Enrollment, lottery, financial incentives

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.

Interventions

BEHAVIORALFinancial 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Enrollment and participation ratesEnd of study- 6 months after enrollmentThe 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

MeasureTime frameDescription
Uptake of Device UsageEnd of study- 6 months after enrollmentAssess the effect of financial incentives on the use of home health monitoring devices among high-risk patients

Other

MeasureTime frameDescription
Change in Hemoglobin A1cEnd of study- 6 months after enrollmentAssess how regular use of home-based health monitoring devices affects clinical outcomes, such as Hemoglobin A1C

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026