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In-Home Adjustment of New Spinal Cord Injury Caregivers

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Behavioral: Transition Assistance Program

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03244098
439128 (Other Grant/Funding Number)
HM20009566

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

SCI Patient 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)

Caregiver 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
  • 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Transition Assistance Program (TAP)
Experimental group
Treatment:
Behavioral: Transition Assistance Program
Standard of Care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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