- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066959
Improving Diabetes in Emerging Adulthood (IDEA)
December 15, 2022 updated by: April Carcone, Wayne State University
Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention
This project will test the efficacy of a multi-component behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-21) with T1D, a group with chronic poor metabolic control.
This intervention is grounded in self-determination theory which states that a youth who believes their diabetes management is self-directed, competent, and supported by others is more likely to consistently complete their diabetes self-care.
This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and different interventions targeting this population (currently there are no interventions that directly target emerging adults).
Study Overview
Status
Recruiting
Conditions
Detailed Description
This project will use the multiphase optimization strategy (MOST) approach to test the efficacy of an autonomy supportive behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-25) with T1D.
Youth this age demonstrate chronic poor metabolic control that persists into adulthood leading to the premature emergence of short- and long-term diabetes complications.
Developmentally, adolescence and emerging adulthood is a time when the need for independence and autonomy are particularly salient.
This new intervention will leverage youths' desire for autonomy by designing an intervention to support diabetes self-management autonomy.
This intervention is guided by self-determination theory (SDT) which suggests that autonomous (i.e., self-initiated, driven by intrinsic versus extrinsic motivation) diabetes management depends upon three conditions: 1) the perception that one's behavior is self-directed, 2) feelings of competence, or self-efficacy, and 3) the existence of caring relationships supportive of the behavior.
The investigators have identified three intervention components that target the SDT constructs.
A question prompt list (QPL) is a simple, inexpensive tool comprised of a list of questions that patients might consider asking their health care provider during a clinic visit.
QPLs empower patients to assume a more active role (asking questions and stating concerns) during clinic visits.
The Motivation Enhancing System (MES) is an eHealth intervention to increase intrinsic motivation for health behavior change.
MES content is based on the Motivational Interviewing (MI) framework and the Information-Motivation-Behavioral Skills (IMB) model of health behavior change which posits that behavior change results from the joint function of three critical components: accurate information about risk behaviors or their replacement health behaviors, motivation to change behavior, and behavioral skills necessary to perform the behavior (self-efficacy).
Text message reminders (TXT) are a strategy to encourage youth to complete their diabetes self-care that also lead to gains in self-efficacy and a stronger relationship with diabetes care providers through greater communication and satisfaction.
The investigators will test the efficacy of these intervention components toward improving metabolic control in a component selection experiment (N=320).
The experiment will use a full factorial research design with random assignment to determine which intervention components contribute to a clinically significant improvement (≥0.5%) in HbA1c.
The result of this research will be an optimized, multi-component intervention with effect size estimates that will be used to inform a large scale, fully powered effectiveness trial.
This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and behavioral interventions targeting this population (for which there currently are none).
Study Type
Interventional
Enrollment (Anticipated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abigale Vaquera, MPH
- Phone Number: 313-577-5859
- Email: gh4669@wayne.edu
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Detroit Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- Age 16 years, 0 months - 25 years, 11 months
- Type 1 diabetes (T1D)
- HbA1c ≥7.5% currently and averaged over the previous 6 months
- Duration of diabetes ≥6 months
- English fluency, both verbal and written
Cell phone access with texting capability
Exclusion:
- Psychosis (e.g., schizophrenia or bipolar disorder)
- Suicidal
- Developmental delay (moderate or severe mental retardation, or autism) or reading level below sixth grade
- The presence of another physical health condition that results in atypical diabetes management (e.g., cystic fibrosis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Question Prompt List (QPL)
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit.
The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations.
Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care.
QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
|
Experimental: Motivation Enhancement System (MES)
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change.
MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change.
Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success).
Session 1 concludes with goal setting to promote autonomous diabetes self-management.
Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state.
Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
MES is a brief eHealth intervention delivered via an internet-based software application.
MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change.
The goal of MES is to increase motivation to complete daily diabetes care tasks.
MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
|
Experimental: Text Message Reminders (TXT)
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting.
Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion.
TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment.
TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction.
Youth will receive daily reminders to complete key diabetes care tasks.
|
Experimental: QPL & MES
Participants will receive the QPL and MES interventions as described above.
|
A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit.
The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations.
Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care.
QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
MES is a brief eHealth intervention delivered via an internet-based software application.
MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change.
The goal of MES is to increase motivation to complete daily diabetes care tasks.
MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
|
Experimental: QPL & TXT
Participants will receive the QPL and TXT interventions as described above.
|
A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit.
The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations.
Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care.
QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion.
TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment.
TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction.
Youth will receive daily reminders to complete key diabetes care tasks.
|
Experimental: MES & TXT
Participants will receive the MES and TXT interventions as described above.
|
MES is a brief eHealth intervention delivered via an internet-based software application.
MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change.
The goal of MES is to increase motivation to complete daily diabetes care tasks.
MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
|
Experimental: MES, QPL & TXT
Participants will receive the MES, QPL, and TXT interventions as described above.
|
A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit.
The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations.
Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care.
QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
MES is a brief eHealth intervention delivered via an internet-based software application.
MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change.
The goal of MES is to increase motivation to complete daily diabetes care tasks.
MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion.
TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment.
TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction.
Youth will receive daily reminders to complete key diabetes care tasks.
|
No Intervention: Standard Medical Care
Participants will receive standard medical care at one of two participating clinical sites.
Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
|
Hb1Ac will be obtained by using the Accubase A1c test kit.
|
Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes Management Scale
Time Frame: Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
|
The Diabetes Management Scale (DMS) is a self-report measure of daily diabetes care that assesses a broad range of management behaviors, including insulin management, dietary management, blood glucose monitoring, and symptom response with good internal consistency (α=.74 to .84).
Each item asks "What percent of the time do you (take your insulin)?"
The response scale is 0-100%.
A total score is obtained by summing the items to reflect overall management behavior.
|
Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
|
Blood glucose testing
Time Frame: Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
|
The mean daily frequency of blood glucose testing during the 14 days prior to assessment downloaded from blood glucose meters.
|
Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: April Carcone, PhD, Wayne State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2020
Primary Completion (Anticipated)
January 31, 2025
Study Completion (Anticipated)
January 31, 2025
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 26, 2019
Study Record Updates
Last Update Posted (Actual)
December 16, 2022
Last Update Submitted That Met QC Criteria
December 15, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK116901 (U.S. NIH Grant/Contract)
- 1R01DK116901-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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