Clinical trial NCT02638246: Incentives for Internet-based Adherence to SMBG for Teens With T1D
Official title: Incentives for Internet-based Glucose Testing in Adolescent Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contingent Versus Noncontingent Incentives
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: National Development and Research Institutes, Inc.
First posted: 2015-12-23
Enrollment: 52
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.).

Eligibility criteria: 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

Primary outcomes:
measure: Daily frequency of self-monitoring blood glucose
timeFrame: 45 days
measure: Percentage of days conducted at least 4 tests per day.
timeFrame: 45 days
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: 45 days
measure: Feasibility
timeFrame: 45 days
Other outcomes:
Locations:
Study officials:
affiliation: Rowan University
name: Bethany Raiff, PhD
role: PRINCIPAL_INVESTIGATOR
References: