Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study

NCT06256939 | Completed

• 1 other identifier: 2023-0236
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to develop a novel caregiver education and coaching intervention for infants with intraventricular hemorrhage (IVH) and their caregivers during the NICU to home transition. The main questions it aims to answer are:

1. 1.Development of a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition
2. 2.Pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.

Conditions

Intraventricular Hemorrhage

Keywords

IVH; NICU; caregiver education; occupational therapy; physical therapy

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM)

  A client-centered outcome measure that helps identify and prioritize barriers that limit participation in meaningful activities (e.g., play, feeding, sleep, etc.). The COPM is a valid, responsive, and reliable scale that allows researchers to determine clinically significant changes in participants' performance and satisfaction. Participants will rate items on a scale of 1-10 with the average performance/satisfaction scores calculated (higher correlates with higher satisfaction/performance).

  At enrollment and through study completion, an average of 2 months

Secondary Outcomes (2)

• Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program

  At enrollment and through study completion, an average of 2 months

• Therapist Questionnaire of Acceptability of Therapy BRIDGE Program

  To be completed at study completion, an average of 2 months after enrollment

Study Arms (2)

Intervention Group

EXPERIMENTAL

The Therapy BRIDGE program is a prospective, longitudinal, non-randomized pilot study for infants diagnosed with IVH and their caregivers. The Therapy BRIDGE program will begin as the infant is nearing discharge from the NICU and continue as the infant transitions to home. It will use a hybrid model including both in-person and telehealth sessions.

Other: Therapy BRIDGE Program

Control Group

NO INTERVENTION

In the instance that a patient is deemed eligible to participate in the Therapy BRIDGE program and the caregiver chooses not to participate, the caregiver will be offered the opportunity to be enrolled in the control arm of our study as part of a monitoring group. This group of patients will continue to receive usual care while admitted to the NICU and any outpatient recommendations will be deferred to the primary NICU therapists caring for the infant based on the patient's individualized needs.

Interventions

Therapy BRIDGE Program OTHER

A standardized education and coaching intervention will be developed to promote optimal neurodevelopmental outcomes through caregiver empowerment. This pilot study will enroll up to 15 infants with IVH and their caregivers during their NICU stay. These infant-caregiver dyads will receive up to 10 sessions utilizing the Therapy BRIDGE program over a four-month period that spans the hospital to home transition.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of IVH, regardless of age at time of enrollment
• Admission to the Cincinnati Children's Hospital NICU
• Must be at least 18 years of age
• Can provide written consent
• Able to participate in the sessions and data collection process

You may not qualify if:

• Transfer out of the NICU prior to discharge or require tracheostomy with ventilator dependence as they will not be discharged directly from the CCHMC NICU
• Infants and caregivers who live outside of the CCHMC service area and will not be eligible for follow up with CCHMC therapies will be excluded.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Grace Sagester, OTD, OTR/L, BCP

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Ashley Pinger, PT, DPT, PCS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator, Occupational Therapist, Division of Occupational & Physical Therapy

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 13, 2024
• Study Start: November 16, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)