Take Charge of Your Diabetes

NCT01977495 | Completed

• 1 other identifier: 818810
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Uptake of Device Usage

  End of study- 6 months after enrollment

Other Outcomes (1)

• Change in Hemoglobin A1c

  End of study- 6 months after enrollment

Study Arms (2)

Opt-in Enrollment

ACTIVE COMPARATOR

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

Opt-out enrollment

ACTIVE COMPARATOR

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

Interventions

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.

Opt-in Enrollment; Opt-out enrollment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jaya Aysola, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 6, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

US (1)