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In-Home Adjustment of New Spinal Cord Injury Caregivers

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transition Assistance Program
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transition Assistance Program (TAP)

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Zarit Burden Interview - Change from Baseline, at 2 and 4 Months after Discharge
22 item self-report measuring perceived burden on a 4 point scale [(1) Never, (2) Sometimes, (3) Quite Frequently, (4) Nearly Always] Given to the caregiver only in all treatment groups.
The Self-Perceived Burden Scale - Patient - Change from Baseline, at 2 and 4 Months after Discharge
25 item self-report measuring perceived self-burden on a 5 point scale [(1) None of the time, (2) A little of the time, (3) Some of the time, (4) Most of the time, (5) All of the time] Given to the patient only in all treatment groups.
Short Form - VR 12 Health Survey - Change from Baseline, at 2 and 4 Months after Discharge
12 item self-report measuring participant views on his/her own health. Various scales included: 6 point scale [(1) All of the time, (2) Most of the time, (3) A good bit of the time, (4) Some of the time, (5) A little bit of the time, (6) None of the time] 5 point scale [(1) Excellent, (2) Very good, (3) Good, (4) Fair, (5) Poor] 5 point scale [(1) Much Better, (2) Slightly Better, (3) About the Same, (4) Slightly Worse, (5) Much Worse] 5 point scale [(5) All of the time, (4) Most of the time, (3) Some of the time, (2) A little bit of the time, (1) None of the time] 3 point scale [(1) Yes, limited a lot, (2) Yes, limited a little, (3) No, Not limited at all] Given to both the patient and caregiver in all treatment groups.
SCI-QOL Positive Affect & Well-Being - Change from Baseline, at 2 and 4 Months after Discharge
10 item self-report measuring perceived well-being on a 5 point scale [(1) Never, (2) Rarely, (3) Sometimes, (4) Often, (5) Always] Given to both the patient and caregiver in all treatment groups.
Spinal Cord Independence Measure - Change from Baseline, at 2 and 4 Months after Discharge
19 item self-report measuring spinal cord injury patient's independence. Each item is scored using the following scales [totals range from 0-100]: 0, 1 0, 1, 2 0, 1, 2, 3 0, 2, 4, 6 0, 5, 8, 10 0, 1, 2, 3, 4 0, 1, 2, 4, 5 0, 2, 4, 6, 8, 10 0, 3, 6, 9, 11, 13, 15 0, 1, 2, 3, 4, 5, 6, 7, 8 Each item's scale includes descriptive explanations of levels of independence. Example: 0. Requires total assistance Requires partial assistance; does not clean self Requires partial assistance; cleans self independently 4. Uses toilet independently in all tasks but needs adaptive devices or special setting (e.g., bars) 5. Uses toilet independently; does not require adaptive devices or special setting) Given to the patient only in all treatment groups.
Revised Scale for Caregiving Self-Efficacy - Change from Baseline, at 2 and 4 Months after Discharge
15 item (+4 practice items) self-report measuring perceived self-efficacy on an 11 point scale [from 0 to 100 in increments of 10; ranging from "cannot do at all" (0) to "moderately certain can do" (50) to, "certain can do" (100)] Given to the caregiver only in all treatment groups.
Relationship Assessment Scale - Change from Baseline, at 2 and 4 Months after Discharge
7 item self-report measuring perceived relationship between the caregiver and patient on a 5 point scale [ranging from (1) "Not at all" to (5) "Very much"] Given to both the caregiver and patient in all treatment groups.
Exemplary Care Scale - Change from Baseline, at 2 and 4 Months after Discharge
11 item self-report measuring perceived quality of care by/from the caregiver on a 4 point scale [(1) Never, (2) Sometimes, (3) Often, (4) Always] Given to both the caregiver and patient in all treatment groups.
Center for Epidemiologic Studies Depression Scale - Change from Baseline, at 2 and 4 Months after Discharge
20 item self-report measuring days of depressive symptoms within the last week on a 5 point scale [(0) Not at all or less than 1 day, (1) 1-2 days, (2) 2-4 days, (3) 5-7 days, (4) Nearly every day for 2 weeks] Given to both the caregiver and patient in all treatment groups.
Dissemination & Implementation Questions
33 item self-report measuring satisfaction with the TAP intervention on a 7 point scale [(1) Never, (2) Rarely, (3) Occasionally, (4) Sometimes, (5) Often, (6) Very Often, (7) Always] as well as three open ended questions. Given to the caregiver only in TAP group.
ADAPSS - Change from Baseline, at 2 and 4 Months after Discharge
6 item self-report measuring perception of SCI on a 6 point scale [(1) Strongly Disagree, (2) Moderately Disagree, (3) Mildly Disagree, (4) Mildly Agree, (5) Moderately Agree, (6) Strongly Agree] Given to only the patient in all treatment groups.
Brief COPE - Change from Baseline, at 2 and 4 Months after Discharge
10 item self-report measuring methods of coping on a 4 point scale [(1) I usually don't do this at all, (2) I usually do this a little bit, (3) I usually do this a medium amount, (4) I usually do this a lot] Given to both the patient and caregiver in all treatment groups.
Craig Handicap Assessment and Reporting Technique (CHART) Short Form - Change from Baseline, at 2 and 4 Months after Discharge
17 item self-report measuring the level of handicap in a community setting including free response of whole numbers (ex: number of times per week left alone), as well as Yes/No/Not Applicable) Given to only the patient in all treatment groups.
Cognitive Flexibility Scale - Change from Baseline, at 2 and 4 Months after Discharge
12 item self-report measuring cognitive flexibility regarding problem solving on a 6 point scale [(1) Strongly Agree, (2) Agree, (3) Slightly Agree, (4) Slightly Disagree, (5) Disagree, (6) Strongly Disagree] Given to both the patient and caregiver in all treatment groups.
Disability Identity and Opportunity Scale - Change from Baseline, at 2 and 4 Months after Discharge
23 item self-report measuring attitudes towards being disabled on a 5 point scale [(1) Strongly Disagree, (5) Strongly Disagree] Given to only the patient in all treatment groups.
Family Dynamics Scale - Change from Baseline, at 2 and 4 Months after Discharge
15 item self-report scale measuring perceived family dynamics (including communication, adaptability, etc.) on a 6 point scale [(1) Extremely Well, (2) Very Well, (3) Well, (4) A Bit, (5) Not Well, (6) Not at All] Given only to the caregiver in all treatment groups.
Generalized Anxiety Disorder 7 (GAD 7) - Change from Baseline, at 2 and 4 Months after Discharge
7 item self-report scale measuring level of anxiety over the last 2 weeks on a 4 point scale [(0) Always, (1) Often, (2) Sometimes, (3) Occasionally] Given to both the patient and caregiver in all treatment groups.
Spinal Cord Injury Coping Questionnaire - Change from Baseline, at 2 and 4 Months after
12 item self-report scale measuring the acceptance, fighting spirit, and social reliance of an SCI patient on a 4 point scale [(1) Strongly Agree, (2) Agree, (3) Disagree, (4) Strongly Disagree] Given to only the patient in all treatment groups
Ten-Item Personality Inventory - Change from Baseline, at 2 and 4 Months after
10 item self-report scale measuring personality (based on the Big 5) on a 7 point scale [(1) Disagree Strongly, (2) Disagree Moderately, (3) Disagree a Little, (4) Neither Agree nor Disagree, (5) Agree a Little, (6) Agree Moderately, (7) Agree Strongly] Given to both the patient and caregiver in all treatment groups

Secondary Outcome Measures

Demographics - Patient
34 item self-report demographics survey, including specific information regarding the SCI and relationship between the patient and caregiver. 16 items on baseline and 18 items for the two follow up sessions. Given to the patient only in all treatment groups.
Demographics - Caregiver
31 item self-report demographics survey, including specific information regarding the relationship between the caregiver and patient. 20 items on baseline and 11 items for the two follow up sessions. Given to the caregiver only in all treatment groups.
Brief Health Literacy Screening Tool
4 item self-report measuring caregiver literacy on a 5 point scale [(1) Always, (2) Often, (3) Sometimes, (4) Occasionally, (5) Never] Given to the caregiver only in all treatment groups.

Full Information

First Posted
August 1, 2017
Last Updated
May 2, 2022
Sponsor
Virginia Commonwealth University
Collaborators
Hunter Holmes McGuire VA Medical Center, The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03244098
Brief Title
In-Home Adjustment of New Spinal Cord Injury Caregivers
Official Title
In-Home Adjustment of New Spinal Cord Injury Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Hunter Holmes McGuire VA Medical Center, The Craig H. Neilsen Foundation

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transition Assistance Program (TAP)
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Transition Assistance Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Zarit Burden Interview - Change from Baseline, at 2 and 4 Months after Discharge
Description
22 item self-report measuring perceived burden on a 4 point scale [(1) Never, (2) Sometimes, (3) Quite Frequently, (4) Nearly Always] Given to the caregiver only in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
The Self-Perceived Burden Scale - Patient - Change from Baseline, at 2 and 4 Months after Discharge
Description
25 item self-report measuring perceived self-burden on a 5 point scale [(1) None of the time, (2) A little of the time, (3) Some of the time, (4) Most of the time, (5) All of the time] Given to the patient only in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Short Form - VR 12 Health Survey - Change from Baseline, at 2 and 4 Months after Discharge
Description
12 item self-report measuring participant views on his/her own health. Various scales included: 6 point scale [(1) All of the time, (2) Most of the time, (3) A good bit of the time, (4) Some of the time, (5) A little bit of the time, (6) None of the time] 5 point scale [(1) Excellent, (2) Very good, (3) Good, (4) Fair, (5) Poor] 5 point scale [(1) Much Better, (2) Slightly Better, (3) About the Same, (4) Slightly Worse, (5) Much Worse] 5 point scale [(5) All of the time, (4) Most of the time, (3) Some of the time, (2) A little bit of the time, (1) None of the time] 3 point scale [(1) Yes, limited a lot, (2) Yes, limited a little, (3) No, Not limited at all] Given to both the patient and caregiver in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
SCI-QOL Positive Affect & Well-Being - Change from Baseline, at 2 and 4 Months after Discharge
Description
10 item self-report measuring perceived well-being on a 5 point scale [(1) Never, (2) Rarely, (3) Sometimes, (4) Often, (5) Always] Given to both the patient and caregiver in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Spinal Cord Independence Measure - Change from Baseline, at 2 and 4 Months after Discharge
Description
19 item self-report measuring spinal cord injury patient's independence. Each item is scored using the following scales [totals range from 0-100]: 0, 1 0, 1, 2 0, 1, 2, 3 0, 2, 4, 6 0, 5, 8, 10 0, 1, 2, 3, 4 0, 1, 2, 4, 5 0, 2, 4, 6, 8, 10 0, 3, 6, 9, 11, 13, 15 0, 1, 2, 3, 4, 5, 6, 7, 8 Each item's scale includes descriptive explanations of levels of independence. Example: 0. Requires total assistance Requires partial assistance; does not clean self Requires partial assistance; cleans self independently 4. Uses toilet independently in all tasks but needs adaptive devices or special setting (e.g., bars) 5. Uses toilet independently; does not require adaptive devices or special setting) Given to the patient only in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Revised Scale for Caregiving Self-Efficacy - Change from Baseline, at 2 and 4 Months after Discharge
Description
15 item (+4 practice items) self-report measuring perceived self-efficacy on an 11 point scale [from 0 to 100 in increments of 10; ranging from "cannot do at all" (0) to "moderately certain can do" (50) to, "certain can do" (100)] Given to the caregiver only in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Relationship Assessment Scale - Change from Baseline, at 2 and 4 Months after Discharge
Description
7 item self-report measuring perceived relationship between the caregiver and patient on a 5 point scale [ranging from (1) "Not at all" to (5) "Very much"] Given to both the caregiver and patient in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Exemplary Care Scale - Change from Baseline, at 2 and 4 Months after Discharge
Description
11 item self-report measuring perceived quality of care by/from the caregiver on a 4 point scale [(1) Never, (2) Sometimes, (3) Often, (4) Always] Given to both the caregiver and patient in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Center for Epidemiologic Studies Depression Scale - Change from Baseline, at 2 and 4 Months after Discharge
Description
20 item self-report measuring days of depressive symptoms within the last week on a 5 point scale [(0) Not at all or less than 1 day, (1) 1-2 days, (2) 2-4 days, (3) 5-7 days, (4) Nearly every day for 2 weeks] Given to both the caregiver and patient in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Dissemination & Implementation Questions
Description
33 item self-report measuring satisfaction with the TAP intervention on a 7 point scale [(1) Never, (2) Rarely, (3) Occasionally, (4) Sometimes, (5) Often, (6) Very Often, (7) Always] as well as three open ended questions. Given to the caregiver only in TAP group.
Time Frame
One day
Title
ADAPSS - Change from Baseline, at 2 and 4 Months after Discharge
Description
6 item self-report measuring perception of SCI on a 6 point scale [(1) Strongly Disagree, (2) Moderately Disagree, (3) Mildly Disagree, (4) Mildly Agree, (5) Moderately Agree, (6) Strongly Agree] Given to only the patient in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Brief COPE - Change from Baseline, at 2 and 4 Months after Discharge
Description
10 item self-report measuring methods of coping on a 4 point scale [(1) I usually don't do this at all, (2) I usually do this a little bit, (3) I usually do this a medium amount, (4) I usually do this a lot] Given to both the patient and caregiver in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Craig Handicap Assessment and Reporting Technique (CHART) Short Form - Change from Baseline, at 2 and 4 Months after Discharge
Description
17 item self-report measuring the level of handicap in a community setting including free response of whole numbers (ex: number of times per week left alone), as well as Yes/No/Not Applicable) Given to only the patient in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Cognitive Flexibility Scale - Change from Baseline, at 2 and 4 Months after Discharge
Description
12 item self-report measuring cognitive flexibility regarding problem solving on a 6 point scale [(1) Strongly Agree, (2) Agree, (3) Slightly Agree, (4) Slightly Disagree, (5) Disagree, (6) Strongly Disagree] Given to both the patient and caregiver in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Disability Identity and Opportunity Scale - Change from Baseline, at 2 and 4 Months after Discharge
Description
23 item self-report measuring attitudes towards being disabled on a 5 point scale [(1) Strongly Disagree, (5) Strongly Disagree] Given to only the patient in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Family Dynamics Scale - Change from Baseline, at 2 and 4 Months after Discharge
Description
15 item self-report scale measuring perceived family dynamics (including communication, adaptability, etc.) on a 6 point scale [(1) Extremely Well, (2) Very Well, (3) Well, (4) A Bit, (5) Not Well, (6) Not at All] Given only to the caregiver in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Generalized Anxiety Disorder 7 (GAD 7) - Change from Baseline, at 2 and 4 Months after Discharge
Description
7 item self-report scale measuring level of anxiety over the last 2 weeks on a 4 point scale [(0) Always, (1) Often, (2) Sometimes, (3) Occasionally] Given to both the patient and caregiver in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Spinal Cord Injury Coping Questionnaire - Change from Baseline, at 2 and 4 Months after
Description
12 item self-report scale measuring the acceptance, fighting spirit, and social reliance of an SCI patient on a 4 point scale [(1) Strongly Agree, (2) Agree, (3) Disagree, (4) Strongly Disagree] Given to only the patient in all treatment groups
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Ten-Item Personality Inventory - Change from Baseline, at 2 and 4 Months after
Description
10 item self-report scale measuring personality (based on the Big 5) on a 7 point scale [(1) Disagree Strongly, (2) Disagree Moderately, (3) Disagree a Little, (4) Neither Agree nor Disagree, (5) Agree a Little, (6) Agree Moderately, (7) Agree Strongly] Given to both the patient and caregiver in all treatment groups
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Secondary Outcome Measure Information:
Title
Demographics - Patient
Description
34 item self-report demographics survey, including specific information regarding the SCI and relationship between the patient and caregiver. 16 items on baseline and 18 items for the two follow up sessions. Given to the patient only in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Demographics - Caregiver
Description
31 item self-report demographics survey, including specific information regarding the relationship between the caregiver and patient. 20 items on baseline and 11 items for the two follow up sessions. Given to the caregiver only in all treatment groups.
Time Frame
Baseline, 2 months after discharge, 4 months after discharge
Title
Brief Health Literacy Screening Tool
Description
4 item self-report measuring caregiver literacy on a 5 point scale [(1) Always, (2) Often, (3) Sometimes, (4) Occasionally, (5) Never] Given to the caregiver only in all treatment groups.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul B Perrin, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33779569
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.
Results Reference
derived

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In-Home Adjustment of New Spinal Cord Injury Caregivers

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