Clinical trial NCT04066959: Improving Diabetes in Emerging Adulthood
Official title: Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: emerging adults
ehealth intervention
diabetes
diabetes management
adolescents
self-determination theory
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-08-26
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study will use an 8-arm full factorial design. In arms 1-3 participants will receive 1 of the 3 intervention components, arms 4-6 receive a combination of 2 components, arm 7 receives all 3 components, and arm 8 is the standard care control. The study will use the mixed effects linear model for the ANOVA of a factorial design powered on the main effects to identify the intervention components that significantly contribute to a clinically significant improvement in HbA1c. Each model will include a random intercept and slope and fixed effects for treatment combinations and time, as well as the stratification variable. The component selection experiment will result in empirical evidence supporting the efficacy of an autonomy support intervention composed of one or more components to improve metabolic control.
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
Secondary outcomes:
measure: Diabetes Management Scale
timeFrame: Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
measure: Blood glucose testing
timeFrame: Change from Baseline at 3 months (end of treatment) and change from baseline at 6 months (post-treatment)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
Study officials:
affiliation: Wayne State University
name: April Carcone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.