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NCT02161913 · ClinicalTrials.gov registry record · NA

Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers

A NA study of Spinal Cord Injury, sponsored by St. Luke's Rehabilitation Institute.

Completed
Registry status
NA
Development phase
38
Enrollment target
1
Study location

NCT02161913 is a NA study of Spinal Cord Injury that has completed, run by St. Luke's Rehabilitation Institute. The registered enrollment target is 38 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02161913, a NA study of Spinal Cord Injury, has completed, sponsored by St. Luke's Rehabilitation Institute.

COMPLETED
Registry status
NA
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

Each year over 12,000 spinal cord injuries (SCI) occur in the United States. These injuries result in incredibly difficult, long-term, life adjustments both for patients and their caregivers. Many families continue to struggle with the physical, emotional and social impacts of SCI for months and years after the injury. Family education and support improves the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but little effort has been made to provide such interventions for persons with SCI and their caregivers. The proposed study will address this problem by refining and testing a group treatment for SCI called Multi-family Group (MFG) intervention. The groups will include people with SCI and their primary caregivers, and will be facilitated by an "educator" who is a health care provider who works with people with SCI. By providing education about the management of SCI and support in an MFG format, quality of life for persons with SCI is predicted to be improved. In turn, it is expected that caregivers will also benefit from the information, problem-solving activities, and social support that they receive from the educators and other group members. The investigators will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous three years and their primary caregivers. Participants will be randomized to the MFG intervention or to an education control condition and tested before and after treatment and 6 months following treatment. It is hypothesized that participants receiving MFG-SCI will have better outcomes than controls on measures of quality of life, health, and adjustment. The study will also test whether participants who are more recently discharged from inpatient rehabilitation will experience greater benefit from the MFG intervention or the education control intervention. If the outcomes support the hypotheses, the MFG intervention should be made available to those with SCI a

Conditions Studied

Interventions

  • BEHAVIORAL Multi-Family Group Treatment
  • BEHAVIORAL SCI Education Control Group

Study Locations (1)

Washington

  • St. Luke's Rehabilitation Institute - Spokane

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2014-09
Est. Completion 2019-04
Phase NA

What the Registry Record Tells You About NCT02161913

The ClinicalTrials.gov registry entry for NCT02161913 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (56% lower). The listed sponsor is St. Luke's Rehabilitation Institute, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Multi-Family Group Treatment is the first listed.

NCT02161913 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT02161913 about?

NCT02161913 is a clinical study titled "Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers". Each year over 12,000 spinal cord injuries (SCI) occur in the United States. These injuries result in incredibly difficult, long-term, life adjustments both for patients and their caregivers. Many families continue to struggle with the physical, emotional and social impacts of SCI for months and yea...

What is the current status of trial NCT02161913?

This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2014-09. Estimated completion is 2019-04.

What conditions does trial NCT02161913 study?

This clinical trial studies the following conditions: Spinal Cord Injury.

What interventions are being tested in trial NCT02161913?

The interventions under investigation include: Multi-Family Group Treatment (BEHAVIORAL), SCI Education Control Group (BEHAVIORAL).

Who is sponsoring clinical trial NCT02161913?

This trial is sponsored by St. Luke's Rehabilitation Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02161913 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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