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| ID | Type | Description | Link |
|---|---|---|---|
| 439128 | Other Grant/Funding Number | Craig H Nielson Foundation |
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| Name | Class |
|---|---|
| Hunter Holmes McGuire VA Medical Center | FED |
| The Craig H. Neilsen Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transition Assistance Program (TAP) | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition Assistance Program | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
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Inclusion Criteria:
SCI Patient Inclusion Criteria:
Caregiver Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul B Perrin, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42240614 | Derived | Watson JD, Mcdonald SD, Donovan EK, Pierce BS, Tyler CM, Mutchler B, Ellwood M, Elliott TR, Mickens MN, Burke J, Perrin PB. Telehealth transition assistance program for new spinal cord injury caregivers: A randomized clinical trial. J Spinal Cord Med. 2026 Jun 4:1-15. doi: 10.1080/10790268.2026.2671476. Online ahead of print. | |
| 33779569 |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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
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 | 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | One day |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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 | Baseline, 2 months after discharge, 4 months after discharge |
| 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 | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | Baseline, 2 months after discharge, 4 months after discharge |
| 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. | One day |
| 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. |
| D014947 | Wounds and Injuries |