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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAxIM
Usual Care
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MAxIM

Usual Care

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 19, 2012
Last Updated
May 4, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01722643
Brief Title
Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes
Official Title
Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAxIM
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MAxIM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c at 12 Months
Description
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
Time Frame
12 months following enrollment
Secondary Outcome Measure Information:
Title
Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment
Description
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.
Time Frame
12 months following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Stanger, PhD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth College
City
Hanover
State/Province
New Hampshire
ZIP/Postal Code
03755
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32508201
Citation
Crochiere RJ, Hughes Lansing A, Carracher A, Vaid E, Stanger C. Attentional bias to diabetes cues mediates disease management improvements in a pilot randomized controlled trial for adolescents with type 1 diabetes. J Health Psychol. 2021 Dec;26(14):2699-2710. doi: 10.1177/1359105320926535. Epub 2020 Jun 7.
Results Reference
derived
PubMed Identifier
30418521
Citation
Stanger C, Lansing AH, Scherer E, Budney A, Christiano AS, Casella SJ. A Web-Delivered Multicomponent Intervention for Adolescents with Poorly Controlled Type 1 Diabetes: A Pilot Randomized Controlled Trial. Ann Behav Med. 2018 Nov 12;52(12):1010-1022. doi: 10.1093/abm/kay005.
Results Reference
derived

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

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