Clinical trial NCT05820477: FAMS-T1D Self-Regulation and Social Support for T1D
Official title: Improving Self-Regulation and Social Support for Type 1 Diabetes During Emerging Adulthood (FAMS-T1D)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Keywords: emerging adults
social support
goal setting
diabetes distress
HbA1c
self-efficacy
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: University of California, Merced
name: Children's Hospital Los Angeles
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-19
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to evaluate how effective the FAMS-T1D intervention is for improving self-regulation (e.g., setting and meeting goals for type 1 diabetes) and social support for meeting those goals for young adults. The main questions that are examined include 1) whether the intervention improves blood glucose, self-management and diabetes distress across time, 2) whether these improvements occur through better self-regulation and social-regulation, 3) whether the intervention improves outcomes for support persons (a friend or family member invited to participate by the person with diabetes) without increasing support burden and 4) whether the intervention improves for persons with diabetes who are on continuous blood glucose monitor their time in range.

Detailed description: This 12-month intervention is an adaptation and expansion of an intervention originally developed for adults with type 2 diabetes (FAMS; NCT02481596) for young adults with type 1 diabetes. FAMS-T1D includes multiple components:

* Monthly coaching sessions (20-30 minutes each) with young adults with type 1 diabetes by phone. The coaching focuses on how to set specific and achievable diabetes goals and to increase helpful and decrease unhelpful family and friend behaviors related to those goals.
* Daily text messages to the person with diabetes to support meeting diabetes goals and engage support that is helpful in meeting those goals.
* Weekly text messages where the person with diabetes responds to how well they have met their goals followed by personalized feedback from the coach.
* The option to invite an adult support person to also receive text messages that assist the support person in providing support that assists the person with diabetes in meeting their goals set in the coaching sessions.

Participants will be randomized to either the intervention or an active control where individuals receive materials relevant to their type 1 diabetes. We plan to enroll 280 persons with diabetes and support persons (optional for persons with diabetes). Persons with type 1 diabetes and their support person (when enrolled) will be randomized together. The study is powered to detect a .5% reduction in hemoglobin A1c. Analyses will examine effects at 6 months (post intervention) and at 12 months (maintenance of effects). The investigators will impute missing data and individuals will be analyzed as randomized irrespective of whether they withdraw or remain in the study following intention-to-treat principals.

Eligibility criteria: Inclusion Criteria:

PERSONS WITH DIABETES

* Ages 18-24
* Have a diagnosis of T1D and has been taking insulin for at least one year
* Comfortable sending texts
* Can speak, read, and write in English
* Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2).

SUPPORT PERSON

* Can speak, read, and write in either English or Spanish
* Comfortable sending and receiving texts
* Ages 18 and older

Exclusion Criteria:

PATIENTS:

* Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
* Plans to live outside of the country during study period.

SUPPORT PERSON

* Shares a phone with the patient participant.
* Plans to live outside of the country during study period.

Primary outcomes:
measure: Change in HbA1c (Person with Diabetes)
timeFrame: Baseline and 6, 9, and 12 months post baseline
measure: Change in Self-Management (Person with Diabetes)
timeFrame: Baseline and 6, 9, and 12 months post baseline
Secondary outcomes:
measure: Diabetes Distress (Person with Diabetes)
timeFrame: Baseline and 6, 9, and 12 months post baseline
Other outcomes:
measure: Change in Self-Regulation Failures (Person with Diabetes)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in Self-Efficacy (Person with Diabetes)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in Goal planning (Person with Diabetes)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in Disclosure (Person with Diabetes)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in Helpful and Harmful Friend and Family Involvement (Person with Diabetes)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in emotional support (Person with Diabetes)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Time in range (Person with Diabetes)
timeFrame: Measured continuously from baseline through 12 months post baseline
measure: Change in solicitation of information from patient (support person)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in support burden (support person)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in Diabetes Distress (support person)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
measure: Change in Helpful and Harmful Friend and Family Involvement (support person)
timeFrame: Baseline, and 6, 9, and 12 months post baseline.
measure: Change in emotional support (support person)
timeFrame: Baseline, and 6, 9, and 12 months post baseline
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: