Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families (R2D2)
Primary Purpose
Type 1 Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
R2D2 mHealth intervention
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- child age between 8-12 years, physician confirmed T1D diagnosis,
- either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points,
- child is on an intensive insulin regimen (pump or MDI).
Exclusion Criteria:
- children on a conventional insulin regimen, children and/or parents who do not report diabetes distress levels at or above the clinical cut-points,
- children who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM, children with a comorbid chronic condition (e.g., renal disease),
- children and parents who do not speak English.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
R2D2 mHealth treatment for diabetes distress
Standard Care Control
Arm Description
This is a mHealth supported, cognitive behavioral treatment for parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program
Parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program will receive local resources (print or electronic).
Outcomes
Primary Outcome Measures
youth glycated hemoglobin (HbA1c)
proxy measure of average glycemic levels over 10-12 weeks
youth time in range
based on continuous glucose levels, the percentage of time spent between 70-180mg/dl
Secondary Outcome Measures
Problem Areas in Diabetes-Child (PAID-C)
validated child report of diabetes distress; range: 11-66, higher scores reflect greater distress
Parent Problem Areas in Diabetes-Child (P-PAID-C)
validated parent report of diabetes distress; range 16-96, higher scores reflect greater distress
Diabetes Strengths and Resilience
validated child report of resilience; range: 12-60, higher scores reflect greater resilience
Brief Resilience Scale
validated adult report of resilience; range 1-5, higher scores reflect greater resilience
Full Information
NCT ID
NCT05268250
First Posted
February 16, 2022
Last Updated
July 31, 2023
Sponsor
Nemours Children's Clinic
Collaborators
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT05268250
Brief Title
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
Acronym
R2D2
Official Title
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
Collaborators
Children's Mercy Hospital Kansas City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in families of school-age children with T1D (called Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to reduce diabetes distress to improve children's glycemic control.
Detailed Description
Only 22% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of <7.5% while the majority of school-age children who exceed this target are at higher risk for T1D-related complications. Achieving optimal T1D self-care is the only direct pathway to better HbA1c and even with the addition of modern therapeutic modalities (e.g., hybrid closed loop), it is a complex, time-consuming, and relentless task. School-age children cannot effectively manage T1D alone and require help from their parents to participate in daily T1D self-care. The research suggests that both parents and youth with T1D are vulnerable to Diabetes Distress (DD) and the American Diabetes Association (ADA) Standards of Care recommend ongoing assessment of DD in youth (starting at 7-8-years-old) and their caregiver during routine diabetes clinic visits. Unfortunately, while DD screening may be an ADA Care Standard, there are no practical treatment options for clinics to adopt to treat DD in school-age families in the case of positive screens. The researchers submit this new R01 in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. Our objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for DD in families of school-age children with T1D (called Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to reduce DD to improve children's glycemic control. To enhance scientific rigor, the researchers plan to use the ORBIT model for behavioral intervention development to guide the study design. The specific aims are: 1) Define feasibility and acceptability of our new screen to treat program (R2D2) for DD in school-age families, and 2) Establish initial efficacy of R2D2 to reduce parent and child DD to improve child glycemic control. The researchers propose to address these Aims through an iterative process and multiple projects to complete the necessary formative research to design, build, and prepare to implement R2D2. The researchers then propose to complete a Pilot randomized controlled trial of their R2D2 screen to treat program, testing for its initial efficacy based on child HbA1c and time in range (primary outcomes) and parent and child DD and resilience, and T1D self-care (secondary outcomes; Phase 2b: Pilot, n=180). The impact of the proposed R01 is high because it addresses a critical need for practical and evidence-based solutions for screening and treating DD in families of school-age children, heretofore an understudied patient subgroup. The researchers believe our study optimally responds to the FOA because the research team is multidisciplinary (anchored by a partnership between behavioral science and diabetology), and their R2D2 screen to treat program reflects a practical team approach that can realistically occur in clinic and scale to other centers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R2D2 mHealth treatment for diabetes distress
Arm Type
Experimental
Arm Description
This is a mHealth supported, cognitive behavioral treatment for parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program
Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
Parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program will receive local resources (print or electronic).
Intervention Type
Behavioral
Intervention Name(s)
R2D2 mHealth intervention
Intervention Description
R2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies
Primary Outcome Measure Information:
Title
youth glycated hemoglobin (HbA1c)
Description
proxy measure of average glycemic levels over 10-12 weeks
Time Frame
week 0, week 13
Title
youth time in range
Description
based on continuous glucose levels, the percentage of time spent between 70-180mg/dl
Time Frame
week 0, week 13
Secondary Outcome Measure Information:
Title
Problem Areas in Diabetes-Child (PAID-C)
Description
validated child report of diabetes distress; range: 11-66, higher scores reflect greater distress
Time Frame
week 0, week 13
Title
Parent Problem Areas in Diabetes-Child (P-PAID-C)
Description
validated parent report of diabetes distress; range 16-96, higher scores reflect greater distress
Time Frame
week 0, week 13
Title
Diabetes Strengths and Resilience
Description
validated child report of resilience; range: 12-60, higher scores reflect greater resilience
Time Frame
week 0, week 13
Title
Brief Resilience Scale
Description
validated adult report of resilience; range 1-5, higher scores reflect greater resilience
Time Frame
week 0, week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
child age between 8-12 years, physician confirmed T1D diagnosis,
either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points,
child is on an intensive insulin regimen (pump or MDI).
Exclusion Criteria:
children on a conventional insulin regimen, children and/or parents who do not report diabetes distress levels at or above the clinical cut-points,
children who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM, children with a comorbid chronic condition (e.g., renal disease),
children and parents who do not speak English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susana R Patton, PhD
Phone
9046972000
Email
susana.patton@nemours.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Milkes
Email
amy.milkes@nemours.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana R Patton, PhD
Organizational Affiliation
Nemours Children's Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
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