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In-Home Adjustment of New Spinal Cord Injury Caregivers

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ClinicalTrials.gov Identifier: NCT03244098
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Hunter Holmes McGuire VA Medical Center
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Transition Assistance Program Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: In-Home Adjustment of New Spinal Cord Injury Caregivers
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transition Assistance Program (TAP) Behavioral: Transition Assistance Program
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
No Intervention: Standard of Care



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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:

    1. 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]
    2. 5 point scale [(1) Excellent, (2) Very good, (3) Good, (4) Fair, (5) Poor]
    3. 5 point scale [(1) Much Better, (2) Slightly Better, (3) About the Same, (4) Slightly Worse, (5) Much Worse]
    4. 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]
    5. 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.


  4. 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.

  5. 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

    1. Requires partial assistance; does not clean self
    2. 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.


  6. 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.

  7. Relationship Assessment Scale - Change from Baseline, at 2 and 4 Months after Discharge [ Time Frame: Baseline, 2 months after discharge, 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.

  8. Exemplary Care Scale - Change from Baseline, at 2 and 4 Months after Discharge [ Time Frame: Baseline, 2 months after discharge, 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.

  9. 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 ]
    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.

  10. Dissemination & Implementation Questions [ Time Frame: One day ]

    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.


  11. 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.


  12. Brief COPE - 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 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.


  13. 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 ]

    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.


  14. Cognitive Flexibility Scale - 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 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.


  15. 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.


  16. Family Dynamics Scale - Change from Baseline, at 2 and 4 Months after Discharge [ Time Frame: Baseline, 2 months after discharge, 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.


  17. 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 ]

    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.


  18. 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


  19. 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



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244098


Contacts
Contact: Paul Perrin, PhD (804) 827-3894 pperrin@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Hunter Holmes McGuire VA Medical Center
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Paul B Perrin, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03244098     History of Changes
Other Study ID Numbers: HM20009566
439128 ( Other Grant/Funding Number: Craig H Nielson Foundation )
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System