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Spinal Cord InjuriesNCT03244098

In-Home Adjustment of New Spinal Cord Injury Caregivers

A study testing Transition Assistance Program in people with Spinal Cord Injuries, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Transition Assistance Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
9 Feb 2018to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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.

Read the 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.

Being tested
Transition Assistance Program
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transition Assistance ProgramBehavioural

    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

Study groups in NCT03244098
Study groupRoleWhat they receive
Transition Assistance Program (TAP)ExperimentalNot described
Receives: Behavioral: Transition Assistance Program
Standard of CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  2. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  3. 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:

    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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  4. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  5. 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:

    1. Requires total assistance
    2. Requires partial assistance; does not clean self
    3. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  6. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  7. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  8. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  9. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  10. 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.

    Measured: One day

  11. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  12. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  13. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  14. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  15. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  16. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  17. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  18. 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

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  19. 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

    Measured: Baseline, 2 months after discharge, 4 months after discharge

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  2. 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.

    Measured: Baseline, 2 months after discharge, 4 months after discharge

  3. 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.

    Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start9 Feb 2018
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244098
Sponsor's protocol ID
HM20009566
Other IDs
439128
Status last verified
May 2022
First submitted
1 Aug 2017
Last updated
3 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 42240614

  • 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.

    PubMed 33779569

Questions about this trial

What is this clinical trial studying?

A study testing Transition Assistance Program in people with Spinal Cord Injuries, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Zarit Burden Interview - Change from Baseline, at 2 and 4 Months after Discharge (time frame: Baseline, 2 months after discharge, 4 months after discharge). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244098, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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