Clinical trial NCT03244098: In-Home Adjustment of New Spinal Cord Injury Caregivers
Official title: In-Home Adjustment of New Spinal Cord Injury Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Hunter Holmes McGuire VA Medical Center
name: The Craig H. Neilsen Foundation
First posted: 2017-08-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Zarit Burden Interview - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: The Self-Perceived Burden Scale - Patient - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Short Form - VR 12 Health Survey - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: SCI-QOL Positive Affect & Well-Being - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Spinal Cord Independence Measure - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Revised Scale for Caregiving Self-Efficacy - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Relationship Assessment Scale - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Exemplary Care Scale - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Center for Epidemiologic Studies Depression Scale - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Dissemination & Implementation Questions
timeFrame: One day
measure: ADAPSS - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Brief COPE - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Craig Handicap Assessment and Reporting Technique (CHART) Short Form - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Cognitive Flexibility Scale - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Disability Identity and Opportunity Scale - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Family Dynamics Scale - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Generalized Anxiety Disorder 7 (GAD 7) - Change from Baseline, at 2 and 4 Months after Discharge
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Spinal Cord Injury Coping Questionnaire - Change from Baseline, at 2 and 4 Months after
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Ten-Item Personality Inventory - Change from Baseline, at 2 and 4 Months after
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
Secondary outcomes:
measure: Demographics - Patient
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Demographics - Caregiver
timeFrame: Baseline, 2 months after discharge, 4 months after discharge
measure: Brief Health Literacy Screening Tool
timeFrame: One day
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paul B Perrin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.