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Trial record 3 of 3 for:    Raiff

Incentives for Internet-based Adherence to SMBG for Teens With T1D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02638246
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
National Development and Research Institutes, Inc.
Information provided by (Responsible Party):
Rowan University

Brief Summary:
Self-management of diabetes can result in long-term benefits, such as delaying or preventing the development of a number of unnecessary health complications, and can even reduce the chances of premature death. Because adherence to diabetes self-management often declines during adolescence, it is critically important to develop interventions that increase adherence of diabetes self-management skills in this population.

Condition or disease Intervention/treatment Phase
Contingent Versus Noncontingent Incentives Behavioral: Internet-delivered, Incentive-based intervention + Motivational Interviewing Behavioral: Internet-delivered, non-contingent incentives + Motivational Interviewing Not Applicable

Detailed Description:

Intensive glycemic control among diabetics decreases the risk of both the development and progression of a number of medical complications associated with diabetes. Self-monitoring blood glucose is a critical component of diabetes self-management and is correlated with improvements in glycemic control. Nevertheless, adherence to blood glucose monitoring is generally poor, particularly among youth, with one study reporting that only ~ 25% of adolescents adhered to the recommended frequency of blood glucose testing.

The current study will use a powerful, scientifically-based behavioral intervention - contingency management (CM) to increase self-monitoring of blood glucose and improve glycemic control among adolescents with Type 1 diabetes. CM involves giving incentives for objective evidence of a target behavior and has been shown to have a robust and reliable impact in promoting behavior change. Our previous research used the Internet to objectively monitor smoking and reinforce smoking cessation (via video recorded carbon monoxide submissions), which resulted in robust increases in smoking abstinence. The current proposal extends this effective Internet-based CM intervention to address the significant health issue of non-adherence to blood glucose testing and glycemic control among youth. Two groups of non-adherent adolescents will be recruited. One group will earn incentives over the Internet for submitting webcam recorded videos that show them testing their blood glucose. A different group will be given standard care recommendations for blood glucose testing and management and will be encouraged to submit glucose monitoring videos, but incentives will not be delivered contingent on submissions (instead, they will earn monetary incentives independent of video submissions, but in an overall amount that matches the earnings of a participant in the other group). The purpose of the study is to evaluate the feasibility, convenience, and efficacy of using Internet-based CM to increase blood glucose monitoring in adolescent Type 1 diabetics.

Combining the accessibility of the Internet with a powerful, evidence-based behavioral intervention can have profound effects on adherence to diabetes self-management in this important population. Improving adherence to diabetes management in adolescents is a significant public health issue - serious medical complications, such as heart disease and nerve damage, that would develop with poor glycemic control can be avoided. Importantly, the current study offers a scientifically-based behavioral intervention that could be applied to a range of populations and behavior relevant to adherence with diabetes regimens (e.g., adults, medication adherence, carbohydrate counting, insulin dose adjustment, etc.).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Incentives for Internet-based Glucose Testing in Adolescent Type 1 Diabetes
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Contingent
Participants in this group received incentives contingent on meeting pre-specified daily blood-glucose testing adherence goals.
Behavioral: Internet-delivered, Incentive-based intervention + Motivational Interviewing
Blood glucose monitoring was verified by videos uploaded to a secure server. Participants in the experimental group received incentives for adherence whereas participants in the control group received adherence independent of adherence.

Active Comparator: Noncontingent
Participants in this group received incentives independent of meeting pre-specified daily blood glucose testing adherence goals.
Behavioral: Internet-delivered, non-contingent incentives + Motivational Interviewing

Primary Outcome Measures :
  1. Daily frequency of self-monitoring blood glucose [ Time Frame: 45 days ]
  2. Percentage of days conducted at least 4 tests per day. [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. Acceptability of the intervention [ Time Frame: 45 days ]
    This was measured using a Treatment Acceptability Questionnaire

  2. Feasibility [ Time Frame: 45 days ]
    Feasibility was based on willingness to participate (recruitment), adherence with the video submission protocol, and attrition

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosed with Type 1 diabetes for at least one year
  • Self-reported self-monitoring blood glucose less than four times per day
  • Lived in a home with Internet access
  • No travel plans within 2 months of enrolling in the study
  • Read and spoke English

Exclusion Criteria:

  • Diagnosis other Type 1 diabetes within one year of screening
  • Not attending regular clinic appointment within 3 months of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02638246

Sponsors and Collaborators
Rowan University
National Development and Research Institutes, Inc.
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Principal Investigator: Bethany Raiff, PhD Rowan University
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Responsible Party: Rowan University Identifier: NCT02638246    
Other Study ID Numbers: R21HD061683-02 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only upon request