Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722643
• Other study ID #: 23559
• Secondary ID: 1DP3HD076602-01
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this project is to develop a novel family friendly intervention that will help teens with poor metabolic control of their type 1 diabetes increase and sustain daily self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic control has long-term health implications. This project will provide important information regarding new effective ways to improve outcomes among teens with poorly controlled type 1 diabetes.

Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and maintain glucose control, and (2) improve decision making (improve executive function and reduce delay discounting), which will predict treatment outcome.

Description:

Type 1 diabetes in adolescents is a significant medical condition associated with high economic costs and increased mortality, and its incidence is increasing. Unfortunately, adolescents show poorer adherence to self monitoring of blood glucose (SMBG) recommendations and poorer metabolic control than adults. Although some individual and family-based interventions have shown promise in improving metabolic control, there is a critical need to develop more effective interventions. The overall goal of this DP3 project is to develop a new innovative intervention that targets decision making to help teens with poor diabetic metabolic control increase the frequency of SMBG and improve HbA1c. The target population will be teens aged 13-17 with type 1 diabetes and HbA1c >8%. Based on our prior work and a conceptual model, the proposed study will develop and pilot test a novel, multifaceted, developmentally appropriate intervention aimed at improving adolescent decision making. An integrated set of components target adolescents' need for frequent positive feedback, improved future orientation, and motivational support. While past research indicates that behavioral interventions are frequently more successful when they include multiple elements, no previous intervention has combined multiple empirically-based components that target key decision making levers in one intervention. This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), an efficacious method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet to increase the reach of the intervention to families living distant from their treating endocrinologist. MAxIM will be teen and parent friendly and designed to increase engagement and compliance with the intervention. Primary hypotheses are that MAxIM will: (1) help teens improve and maintain glucose control, and (2) improve decision making (improve executive function and reduce delay discounting), which will predict treatment outcome. The unique set of interventions holds promise for improving adherence by affecting multiple basic mechanisms that determine poor decision making. The project will develop a novel, highly transportable, home based intervention designed to maximize and sustain HbA1c reductions and SMBG frequency over time in adolescents. Innovations include the targeting of multiple levers specific to adolescent decision making, use of technology to deliver the intervention to families at home, and testing cognitive predictors of treatment outcome for teens with diabetes. Successful achievement of this study's aims will bring the field closer to a cost effective, long-lasting intervention to improve outcomes among these high-risk youth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• 13-17 years old

• Diagnosis of type 1 diabetes

• Average HbA1c > or = to 8% for the past 6 months (mean of two values)

• Most recent HbA1c is > or = to 8%

• Duration of disease is > 18 months

• Teen must live at home

• Family must have broadband internet in the home

Exclusion Criteria:

• Pregnancy/breast feeding

• Active psychosis

• Severe medical or psychiatric illness that will limit participation

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• MAxIM
This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
• Usual Care
Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment—quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.

Locations

Country	Name	City	State
United States	Dartmouth College	Hanover	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c at 12 Months	Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c	12 months following enrollment
Secondary	Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment	Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.	12 months following enrollment