Recruiting

Diabetes Coaching

Sponsor:

Nemours Children's Clinic

Code:

NCT07766811

Conditions

Implementation Science

Type 1 Diabetes in Adolescence

Implementation Strategies

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Base Implementation Toolkit (BIT)

BIT-Enhanced

BIT-Sustainment

Study Details

Brief summary:

The goal of this study is to learn if toolkits of implementation strategies (e.g., provider and staff education, clear plan for how to refer and bill) help pediatric type 1 diabetes medical and psychology providers deliver a behavioral intervention (Diabetes Coaching) to more families. The main questions this study aims to answer are:

  • Is it possible to put these toolkits of implementation strategies into place in one pediatric hospital?
  • Do providers and staff find these toolkits of implementation strategies acceptable?

Participants will be type 1 diabetes professionals (endocrinologists, nurse practitioners, psychologists, scheduling and billing staff) at Nemours Children's Hospital Delaware. Participants will:

  • Attend educational and/or planning meetings
  • Receive email updates on referral data
  • Complete surveys
  • Complete an interview

Conditions

Implementation Science

Type 1 Diabetes in Adolescence

Implementation Strategies

Study ID

NCT07766811

Start date

Aug 26, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Involved in the direct clinical medical care of adolescents with T1D at Nemours Children's Hospital - Delaware OR
2. Involved in the direct clinical psychological care of adolescents with T1D at Nemours Children's Hospital - Delaware OR
3. Involved in the scheduling and/or insurance coverage verification in the clinical psychological care of adolescents with T1D at Nemours Children's Hospital - Delaware OR
4. Holds a leadership role in Endocrinology and/or Behavioral Health at Nemours Children's Hospital - Delaware

Exclusion Criteria:

1\. Not involved in the direct clinical care or administrative parts of care of families with an adolescent with T1D at Nemours Children's Hospital - Delaware

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Implementation Toolkit

In this arm, all participants will receive BIT. If indicated, BIT-Enhanced will be deployed. All participants will receive BIT-Sustainment.

Interventions

Base Implementation Toolkit (BIT)

The Base Implementation Toolkit (BIT) includes strategies across pre-implementation, active implementation, and sustainment phases. Pre-implementation BIT strategies include provider and staff education meetings (e.g., meetings introducing processes for referring and delivering Diabetes Coaching), identification of and training the psychology providers and one medical provider as Champions for implementation and deliverer of Diabetes Coaching (psychology providers only), materials to increase demand for Diabetes Coaching among families (e.g., family-facing educational materials), and development of a workflow blueprint and of tools to monitor implementation. Active implementation BIT strategies include reporting summary level data on uptake of referrals to and family engagement in Diabetes Coaching to clinical type 1 diabetes providers, as well as facilitation (i.e., consultation) to support problem-solving workflow and other implementation challenges.

BIT-Enhanced

During active implementation, two strategies (audit and feedback, adapting delivery format and timing of Diabetes Coaching) may be added to BIT (BIT-Enhanced) to improve adoption among medical providers with lower referral rates (adoption rate <80%) and/or to increase reach if few families schedule and attend Diabetes Coaching (<6 families scheduled per group and/or <4 families attend group). BIT-Enhanced requires additional time and resources (e.g., Champions and providers review individual data, collaborate on ways to increase referrals). Thus, examining if these additional strategies meaningfully improve outcomes offers critical data for maintaining only the strategies that are necessary and sufficient for adoption, reach, and fidelity outcomes.

BIT-Sustainment

Key to maintaining implementation of any evidence-based practice, including Diabetes Coaching, is considering sustainability early on. The primary sustainability strategy (BIT-Sustainment) involves training multiple Champions early and planful progression of their role in the implementation efforts, from first participating in PI-led (implementation and content expert) consultation huddles and shadowing data tracking to then independently leading these huddles, reporting adoption data, and, for those requiring BIT-Enhanced, employing audit and feedback and reach data as needed. The BIT-Sustainment will be deployed for all providers (BIT and BITE) during the sustainment phase of implementation.

Primary outcome measure

  • Feasibility of Implementation Strategies [ Time Frame: Post-completion of Sustainment implementation strategies; 10 months ]
  • Acceptability of Implementation Strategies [ Time Frame: Post-completion of Sustainment implementation strategies (10 months) ]

Central Contacts and Locations

Central contacts

Locations

Nemours Children's Hospital - Delaware

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Implementation strategies
  • Type 1 Diabetes
  • Adolescence
  • Implementation outcomes
  • Psychosocial intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-08-27.