In-Home Adjustment of New Spinal Cord Injury Caregivers

NCT ID: NCT03244098

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2022-05-01

Brief Summary

To improve spinal cord injury (SCI) rehabilitation through stronger informal caregiving, the proposed study will modify and evaluate a telehealth Transition Assistance Program (TAP) for informal caregivers of individuals with SCI during the transition from hospital to home. The TAP was previously developed for stroke caregivers and has been found to decrease caregiver strain and depression. In the proposed study, the TAP will be modified for SCI and implemented at a state-of-the-art SCI rehabilitation facility with a very high volume of SCI treatment and with telehealth technology already in place through which to test the intervention.

Detailed Description

SCI Caregivers will be randomly assigned to either the TAP group or to a control receiving the standard care provided by the rehabilitation facility. The TAP begins before discharge and extends across six weeks. It includes three components to improve caregiver mental health and informal care: (1) skill development, (2) education, and (3) supportive problem solving. TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at 1, 2, 4, and 6 weeks after discharge by the same clinician. Data will be collected from caregivers and individuals with SCI at baseline immediately before discharge and at 2 and 4 months after discharge.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Transition Assistance Program (TAP)

Group Type: EXPERIMENTAL

Transition Assistance Program

Intervention Type: BEHAVIORAL

TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at 1, 2, 4, and 6 weeks after discharge by the same clinician

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transition Assistance Program

TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at 1, 2, 4, and 6 weeks after discharge by the same clinician

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• demonstrate a clinician-rated loss in motor/sensory function on the ASIA scale (i.e., have a spinal cord injury)

• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• are a primary caregiver of the individual with SCI
• Caregivers with scores below 10 on the literacy screen will identify a family member or friend to review the guidebook with the caregiver. If no one is identified, the TAP clinician will review the materials with the caregiver and function in that additional capacity

Exclusion Criteria

• individual with SCI receives his/her primary care from a professional caregiver or other individual outside of the household besides the primary caregiver
• individuals with SCI or caregivers with known current uncontrolled substance dependence, aphasia, anosognosia (deficit in self-awareness), or treatment due to known self-inflicted injury
• individuals living alone
• prisoners
• SCI patient without decision making capacity to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunter Holmes McGuire VA Medical Center

FED

Sponsor Role: collaborator

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul B Perrin, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Perrin PB, McDonald SD, Watson JD, Pierce BS, Elliott TR. Telehealth Transition Assistance Program for Acute Spinal Cord Injury Caregivers: Protocol for a Mixed-Methods, Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 29;10(3):e28256. doi: 10.2196/28256.

Reference Type: DERIVED

PMID: 33779569 (View on PubMed)

Other Identifiers

439128

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20009566

Identifier Type: -

Identifier Source: org_study_id