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OpenTrials
Completed

NCT Number: NCT01977495

Take Charge of Your Diabetes

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Unable to read and give consent
  • Suffer from an uncontrolled psychiatric disease

Treatment and study plan

Financial Incentive: Fixed Lottery

Behavioral

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.

Primary outcomes

  1. Enrollment and participation rates

    Time frame: 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 outcomes

  1. Uptake of Device Usage

    Time frame: 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 outcomes

  1. Change in Hemoglobin A1c

    Time frame: End of study- 6 months after enrollment

    Assess how regular use of home-based health monitoring devices affects clinical outcomes, such as Hemoglobin A1C

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2013
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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