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Hybrid Telehealth in Pediatric Physical Therapy

Primary Purpose

Pediatric Disorder, Disability, Developmental

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid of telehealth and in-person physical therapy services
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Disorder

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 2-17 years old with moderate to significant disability.
  • Families have access to minimum technology necessary to participate in a telehealth visit. ---The child's insurance covers telehealth visits.

Exclusion Criteria:

-Caregiver does not speak English

Sites / Locations

  • University of MissouriRecruiting

Outcomes

Primary Outcome Measures

Change in Canadian Occupational Performance Measure
evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living
Measures of Processes of Care (MPOC)
Survey tool which assesses parents' perceptions of the care they and their children receive from children's rehabilitation treatment centers. Designed to assess the family-centered behaviours of healthcare providers
Change in Pediatric Evaluation of Disability Inventory
Assess key functional capabilities and performance in children whose functional abilities are lower than those of seven-year-olds without disabilities
Semi-structured interviews with caregivers and children in experimental group
Will follow an interview guide designed to capture the experiences of caregivers and children with telehealth

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
March 22, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05350904
Brief Title
Hybrid Telehealth in Pediatric Physical Therapy
Official Title
Does Hybrid Telehealth Physical Therapy for Children With Moderate to Severe Disability Improve Function in the Home Environment Better Than In-person Services Alone?--A Mixed Methods Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. This is a mixed methods study.
Detailed Description
The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. Research questions include: Is a hybrid of telehealth and in-person physical therapy service better than in-person services alone for improving in-home functional skills in children with moderate to severe disability? Is there a difference in the satisfaction of caregivers and children with physical therapy services which consist of a hybrid of telehealth and in-person physical therapy services compared to in-person services alone? What is the experience of children and caregivers who receive a hybrid of telehealth and in-person physical therapy services during an episode of care?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Disorder, Disability, Developmental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control group will receive usual physical therapy care. The experimental group will receive a hybrid of in-person and telehealth services to address in-home functional skills.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Hybrid of telehealth and in-person physical therapy services
Intervention Description
The experimental group will receive a hybrid of telehealth and in-person physical therapy services to address an in-home functional skill in children with moderate to severe disability.
Primary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measure
Description
evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living
Time Frame
after physical therapy episode of care an average of 12 weeks
Title
Measures of Processes of Care (MPOC)
Description
Survey tool which assesses parents' perceptions of the care they and their children receive from children's rehabilitation treatment centers. Designed to assess the family-centered behaviours of healthcare providers
Time Frame
after physical therapy episode of care, an average of 12 weeks
Title
Change in Pediatric Evaluation of Disability Inventory
Description
Assess key functional capabilities and performance in children whose functional abilities are lower than those of seven-year-olds without disabilities
Time Frame
after physical therapy episode of care, an average of 12 weeks
Title
Semi-structured interviews with caregivers and children in experimental group
Description
Will follow an interview guide designed to capture the experiences of caregivers and children with telehealth
Time Frame
after physical therapy episode of care, an average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 2-17 years old with moderate to significant disability. Families have access to minimum technology necessary to participate in a telehealth visit. ---The child's insurance covers telehealth visits. Exclusion Criteria: -Caregiver does not speak English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie B Hall, PT, DPT, PhD
Phone
5738847531
Email
halljami@health.missouri.edu
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie B Hall
Phone
573-884-7531
Email
halljami@health.missouri.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hybrid Telehealth in Pediatric Physical Therapy

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