- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244098
In-Home Adjustment of New Spinal Cord Injury Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
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Experimental: Transition Assistance Program (TAP)
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Zarit Burden Interview - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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.
|
Baseline, 2 months after discharge, 4 months after discharge
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The Self-Perceived Burden Scale - Patient - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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.
|
Baseline, 2 months after discharge, 4 months after discharge
|
Short Form - VR 12 Health Survey - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
|
12 item self-report measuring participant views on his/her own health. Various scales included:
Given to both the patient and caregiver in all treatment groups. |
Baseline, 2 months after discharge, 4 months after discharge
|
SCI-QOL Positive Affect & Well-Being - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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.
|
Baseline, 2 months after discharge, 4 months after discharge
|
Spinal Cord Independence Measure - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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
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. |
Baseline, 2 months after discharge, 4 months after discharge
|
Revised Scale for Caregiving Self-Efficacy - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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.
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Baseline, 2 months after discharge, 4 months after discharge
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Relationship Assessment Scale - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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.
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Baseline, 2 months after discharge, 4 months after discharge
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Exemplary Care Scale - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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.
|
Baseline, 2 months after discharge, 4 months after discharge
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Center for Epidemiologic Studies Depression Scale - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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.
|
Baseline, 2 months after discharge, 4 months after discharge
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Dissemination & Implementation Questions
Time Frame: One day
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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. |
One day
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ADAPSS - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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. |
Baseline, 2 months after discharge, 4 months after discharge
|
Brief COPE - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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. |
Baseline, 2 months after discharge, 4 months after discharge
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Craig Handicap Assessment and Reporting Technique (CHART) Short Form - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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. |
Baseline, 2 months after discharge, 4 months after discharge
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Cognitive Flexibility Scale - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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. |
Baseline, 2 months after discharge, 4 months after discharge
|
Disability Identity and Opportunity Scale - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 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. |
Baseline, 2 months after discharge, 4 months after discharge
|
Family Dynamics Scale - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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. |
Baseline, 2 months after discharge, 4 months after discharge
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Generalized Anxiety Disorder 7 (GAD 7) - Change from Baseline, at 2 and 4 Months after Discharge
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
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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. |
Baseline, 2 months after discharge, 4 months after discharge
|
Spinal Cord Injury Coping Questionnaire - Change from Baseline, at 2 and 4 Months after
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
|
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 |
Baseline, 2 months after discharge, 4 months after discharge
|
Ten-Item Personality Inventory - Change from Baseline, at 2 and 4 Months after
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
|
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 |
Baseline, 2 months after discharge, 4 months after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics - Patient
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
|
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. |
Baseline, 2 months after discharge, 4 months after discharge
|
Demographics - Caregiver
Time Frame: Baseline, 2 months after discharge, 4 months after discharge
|
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. |
Baseline, 2 months after discharge, 4 months after discharge
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Brief Health Literacy Screening Tool
Time Frame: One day
|
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.
|
One day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul B Perrin, PhD, Virginia Commonwealth University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20009566
- 439128 (Other Grant/Funding Number: Craig H Nielson Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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