Improving Diabetes in Emerging Adulthood

Diabetes Mellitus, Type 1 Clinical Trial

— IDEA  

Official title:

Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066959
• Other study ID #: R01DK116901
• Secondary ID: 1R01DK116901-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Wayne State University
• Contact: Abigale Vaquera, MPH
• Phone: 313-577-5859
• Email: gh4669[@]wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

Inclusion:

1. Age 16 years, 0 months - 25 years, 11 months

2. Type 1 diabetes (T1D)

3. HbA1c =7.5% currently and averaged over the previous 6 months

4. Duration of diabetes =6 months

5. English fluency, both verbal and written

6. Cell phone access with texting capability

Exclusion:

7. Psychosis (e.g., schizophrenia or bipolar disorder)

8. Suicidal

9. Developmental delay (moderate or severe mental retardation, or autism) or reading level below sixth grade

10. The presence of another physical health condition that results in atypical diabetes management (e.g., cystic fibrosis)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Motivational Enhancement System (MES)
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.
• Question Prompt List (QPL)
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.
• Text Message Reminders (TXT)
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.

Locations

Country	Name	City	State
United States	Detroit Medical Center	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Idalski Carcone A, Ellis DA, Eggly S, MacDonell KE, Ghosh S, Buggs-Saxton C, Ondersma SJ. Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy. JMIR Res Protoc. 2020 Oct 20;9(10):e20191. doi: 10.2196/20191. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	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	Diabetes Management Scale	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 (a=.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)
Secondary	Blood glucose testing	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)