Biomechanical Validation of the CATT

NCT06013878 | Recruiting

• 2 other identifiers: F4539-R1I01RX004539-01A1
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

As of 2020, 53 million Americans provide unpaid care to an individual with a disability. One commonly performed activity of daily living (ADL) provided by informal caregivers is assisted transfers, which requires moving an individual from one surface to another. Approximately 94% of informal caregivers who assist with ADLs to persons with adult-onset chronic physical disabilities affecting mobility reported musculoskeletal discomfort, with pain and discomfort made worse by performing caregiving activities. Although many informal caregivers assist with transfers, most have never received any formal training in proper manual lifting or mechanical lifting techniques. Improper transfer techniques can be detrimental to not only caregiver health but also to the persons they assist resulting in shoulder injury, bruising and pain from manual lift techniques, hip fractures from falls, and skin tears from shear force that occurs with sliding during transfers. Current standard of care provides limited in-person training of caregivers, as most of the rehabilitation process is client-focused. When training is provided clinicians have no means to objectively evaluate if proper techniques are being performed at discharge or when the caregiver and care recipient return home. For this reason, an outcome measure called the Caregiver Assisted Transfer Technique Instrument (CATT) was developed to provide a quick, objective way to evaluate proper technique of caregivers who provide transfer assistance to individuals with disabilities. The CATT evaluates the caregiver's performance on setup, quality of the task performance, and results. After a formal assessment through stakeholder review involving clinicians, informal caregivers, and individuals with physical disabilities who require transfer assistance, the CATT was expanded to include two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). However, the CATT must undergo further testing with informal caregivers and the individuals they assist to determine if the CATT is a reliable, valid, and responsive tool for identifying skill deficits in caregivers performing assisted transfers. The purpose of this study is to establish the psychometric properties (reliability, validity, and responsiveness) of the CATT and to evaluate the effects of an individualized training session for participants who have transfer technique deficits as identified by the CATT. The long-term goal of this research is to develop the CATT so that it can be used as an objective indicator of transfer performance as well as guide training and educational interventions for informal caregivers to reduce the risk of musculoskeletal pain and injury associated with assisted transfers.

Conditions

Informal Caregivers; Low Back Pain; Biomechanics

Keywords

caregivers; outcome assessment, health care; wheelchairs; physical medicine and rehabilitation; moving and lifting patients

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Assisted Transfer Technique Instrument (CATT) Scores

  An outcome measure called the Caregiver Assisted Transfer Technique Instrument (CATT) was developed to provide a quick, objective way to evaluate proper technique of caregivers who provide transfer assistance to individuals with disabilities. The CATT consists of two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). It uses three subdomains (set up, transfer performance, and results) to assess caregiver technique during transfers. The investigators expect to see improvements in CATT Scores (higher scores) after intervention with a therapist.

  Change from baseline and after intervention at 1 week

Secondary Outcomes (2)

• Change in peak lumbar extension moments

  Change from baseline and after intervention at 1 week

• Change in peak lumbar compression forces

  Change from baseline and after intervention at 1 week

Study Arms (2)

Informal Caregivers

Informal caregivers who provide transfer assistance to an individual with a disability

Other: Transfer Training with clinician

Individuals who use transfer assistance

Individuals who require assistance with transfers moving from one surface to the other

Other: Transfer Training with clinician

Interventions

Transfer Training with clinician OTHER

Participants will undergo transfer training with a clinician who is an expert on assisted transfer techniques if they are found to have skill deficits during the study. After training, a transfer assessment will be conducted to examine if the transfer skills of the caregiver have improved

Individuals who use transfer assistance; Informal Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers and care recipients who are eligible for the study will be recruited through community locations, including rehabilitation facilities, organizations that provide services to both caregivers and individuals with physical disabilities, research registries for individuals with disabilities, and at at national and local rehabilitation events, disability conferences and expos.

You may qualify if:

• Individuals who use assistance with transfers and their caregivers will be recruited for this study.
• Caregiver participants will be included in the study if they meet the following criteria:
• at least 18 years old
• routinely provide transfer assistance to an adult with a physical disability
• serving as a caregiver for at least 3 months
• no formal didactic or structured training on assisted transfer techniques received as part of a professional degree or training program
• Care recipient participants will be included in the study if they meet the following criteria:
• at least 18 years old,
• has a physical disability diagnosis for at least one year
• requires assistance with transfers
• currently receives care from an informal caregiver

You may not qualify if:

• Caregiver participants will be excluded if they:
• \) have a current or recent history of back, neck, or other type of musculoskeletal injury within the last 6 months that would be exacerbated by performing an assisted transfer
• Care recipient participants will be excluded if they:
• have existing pressure ulcers or a recent history of pressure ulcers within the last 3 months
• have any recent upper extremity injuries (within the last 6 months) that could be exacerbated by being transferred

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alicia M Koontz, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia M Koontz, PhD

CONTACT

(412) 383-6596; Alicia.Koontz@va.gov

Nikitha Deepak, MS BS

CONTACT

(412) 822-3669; nikitha.deepak@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: July 24, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)