FAMS-T1D Self-Regulation and Social Support for T1D

Type 1 Diabetes Clinical Trial

— FAMS-T1D  

Official title:

Improving Self-Regulation and Social Support for Type 1 Diabetes During Emerging Adulthood (FAMS-T1D)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05820477
• Other study ID #: 1R01DK124719
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 280
• Est. completion date: April 30, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• FAMS-T1D
Behavioral FAMS-T1D FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled.
• Digital resources for diabetes
Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.

Locations

Country	Name	City	State
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
University of Utah	Children's Hospital Los Angeles, University of California, Merced, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-Regulation Failures (Person with Diabetes)	Self-regulation failures (outcome and mediator) regarding failures in blood glucose checking ranging from 1 to 5 where higher values indicate greater failures.	Baseline, and 6, 9, and 12 months post baseline
Other	Change in Self-Efficacy (Person with Diabetes)	Self-efficacy (outcomes and mediator), with scores ranging from 1 to 10 where higher numbers indicate greater self-efficacy.	Baseline, and 6, 9, and 12 months post baseline
Other	Change in Goal planning (Person with Diabetes)	Goal Planning (outcome and mediator) subscale from the Goal Systems Assessment Battery with scores ranging from 1 to 5 where higher values indicate greater planning.	Baseline, and 6, 9, and 12 months post baseline
Other	Change in Disclosure (Person with Diabetes)	Disclosure (outcome and mediator) as measured by disclosure subscale with scores ranging from 1 to 5 where higher values indicate greater disclosure to family and friends	Baseline, and 6, 9, and 12 months post baseline
Other	Change in Helpful and Harmful Friend and Family Involvement (Person with Diabetes)	Change in Helpful (range 1 to 5, higher scores indicate more helpful involvement) and Harmful friend and family involvement (range 1 to 5, higher scores indicate more harmful involvement) (outcome and mediator) as measured by modified FIAD (Mayberry et al., 2019) for type 1 diabetes management.	Baseline, and 6, 9, and 12 months post baseline
Other	Change in emotional support (Person with Diabetes)	Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support.	Baseline, and 6, 9, and 12 months post baseline
Other	Time in range (Person with Diabetes)	Time in range (outcome). For individuals on a continuous blood glucose monitor (CGM) we collect time in range from their monitor. Higher scores indicate greater time spent with blood glucose values in the target range of 70-180 mg/dL.	Measured continuously from baseline through 12 months post baseline
Other	Change in solicitation of information from patient (support person)	Solicitation of information from patient (outcome and mediator), with higher scores reflecting greater solicitation (range 1 to 5).	Baseline, and 6, 9, and 12 months post baseline
Other	Change in support burden (support person)	Support burden (outcome and mediator), scores range from 0 to 4, higher scores indicate greater burden.	Baseline, and 6, 9, and 12 months post baseline
Other	Change in Diabetes Distress (support person)	Support Person Diabetes Distress (outcome) with scores ranging from 0 to 4, higher scores indicate greater burden.	Baseline, and 6, 9, and 12 months post baseline
Other	Change in Helpful and Harmful Friend and Family Involvement (support person)	Change in helpful (range 1 to 5, higher scores indicate more helpful involvement) and Harmful friend and family involvement (range 1 to 5, higher scores indicate more harmful involvement) (outcome and mediator) as measured by modified FIAD for type 1 diabetes management	Baseline, and 6, 9, and 12 months post baseline.
Other	Change in emotional support (support person)	Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support.	Baseline, and 6, 9, and 12 months post baseline
Primary	Change in HbA1c (Person with Diabetes)	Higher values indicate values more off target. Hemoglobin A1C assessed by mail-in kits from University of Minnesota ARDL	Baseline and 6, 9, and 12 months post baseline
Primary	Change in Self-Management (Person with Diabetes)	Self-care inventory revised, higher values indicate better self-management (values range from 1 to 5)	Baseline and 6, 9, and 12 months post baseline
Secondary	Diabetes Distress (Person with Diabetes)	The Diabetes Distress Scale for Adults with Type 1 Diabetes, higher values indicate greater distress (values range from X to X)	Baseline and 6, 9, and 12 months post baseline