- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06256939
Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study (Therapy BRIDGE)
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:
- 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
- Pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Infants born preterm are often medically complex and at high-risk for neurodevelopmental challenges. During their Neonatal Intensive Care Unit (NICU) stay, infants and caregivers receive continuous support and have constant access to a variety of specialists. Research has shown that caregiver involvement in their infant's care in the NICU helps to improve outcomes. However, caring for these infants upon discharge can be overwhelming to caregivers. Currently, there is no formal intervention in place to support caregivers as they transition their infant home. The overall objectives of the Therapy BRIDGE program are to (1) create a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition and (2) pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.
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. Feasibility and acceptability will be measured with caregiver and therapist questionnaires using a 5-point Likert Scale. Intervention efficacy will be measured by administering the Canadian Occupational Performance Measure (COPM) before and after completion of the program and evaluating change scores.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Grace M Sagester, OTD, OTR/L, BCP
- Phone Number: 513-803-4749
- Email: grace.sagester@cchmc.org
Study Contact Backup
- Name: Ashley Pinger, PT, DPT, PCS
- Phone Number: 5138035217
- Email: ashley.pinger@cchmc.org
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
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Contact:
- Cincinnati Children's Hospital Medical Center
- Phone Number: 5136364200
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Principal Investigator:
- Grace Sagester, OTD, OTR/L, BCP
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Principal Investigator:
- Ashley Pinger, PT, DPT, PCS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for infant participants:
- A diagnosis of IVH, regardless of age at time of enrollment
- Admission to the Cincinnati Children's Hospital NICU
Inclusion Criteria for caregiver participants:
- Must be at least 18 years of age
- Can provide written consent
- Able to participate in the sessions and data collection process
Exclusion Criteria for infant and caregiver participants:
Infants will be excluded if they 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. As the purpose of the Therapy BRIDGE program is to be inclusive of all caregivers, every effort will be made to include any eligible infant-caregiver dyad. Additionally, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
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.
|
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.
|
No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canadian Occupational Performance Measure (COPM)
Time Frame: At enrollment and through study completion, an average of 2 months
|
A client-centered outcome measure that helps identify and prioritize barriers that limit participation in meaningful activities (e.g., play, feeding, sleep, etc.).18, 19 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program
Time Frame: At enrollment and through study completion, an average of 2 months
|
Caregiver questionnaire to measure feasibility and acceptability
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At enrollment and through study completion, an average of 2 months
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Therapist Questionnaire of Acceptability of Therapy BRIDGE Program
Time Frame: To be completed at study completion, an average of 2 months after enrollment
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Questionnaire to measure therapist's acceptability of novel education program
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To be completed at study completion, an average of 2 months after enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0236
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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