Improving Diabetes in Emerging Adulthood (IDEA)

Wayne State University

Status: Completed

Conditions: Diabetes Mellitus, Type 1

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04066959

1R01DK116901-01A1 (U.S. NIH Grant/Contract)

R01DK116901

Details and patient eligibility

About

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).

Full 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).

Enrollment: 113 patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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113 participants in 8 patient groups

Question Prompt List (QPL)

Experimental group

Description:

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.

Treatment:

Behavioral: Question Prompt List (QPL)

Motivation Enhancement System (MES)

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Enhancement System (MES)

Text Message Reminders (TXT)

Experimental group

Description:

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.

Treatment:

Behavioral: Text Message Reminders (TXT)

QPL & MES

Experimental group

Description:

Participants will receive the QPL and MES interventions as described above.

Treatment:

Behavioral: Motivational Enhancement System (MES)

Behavioral: Question Prompt List (QPL)

QPL & TXT

Experimental group

Description:

Participants will receive the QPL and TXT interventions as described above.

Treatment:

Behavioral: Text Message Reminders (TXT)

Behavioral: Question Prompt List (QPL)

MES & TXT

Experimental group

Description:

Participants will receive the MES and TXT interventions as described above.

Treatment:

Behavioral: Motivational Enhancement System (MES)

MES, QPL & TXT

Experimental group

Description:

Participants will receive the MES, QPL, and TXT interventions as described above.

Treatment:

Behavioral: Text Message Reminders (TXT)

Behavioral: Motivational Enhancement System (MES)

Behavioral: Question Prompt List (QPL)

Standard Medical Care

No Intervention group

Description:

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.