NCT04059718

Brief Summary

SCI Thrive is a randomized controlled trial to test the efficacy of SCI Thrive (6 week Peer-Led Online Self-Management Program) to improve quality of life and self-efficacy for individuals with SCI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

August 12, 2019

Last Update Submit

May 16, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Perceived Quality of Life Scale (PQOL)

    The PQOL measures satisfaction with 12 different aspects of life including an individual's contact with family or friends, contribution to the community, meaning and purpose in life, and happiness.

    Collected at enrollment, 6 weeks, and 3 months post treatment

  • Change in Self-Efficacy for Managing Chronic Disease 6-item Scale (SMCD)

    Self-Efficacy for Managing Chronic Disease 6-item Scale (SMCD) is a measure of self-efficacy for managing chronic disease in core domains of symptom control, role function, emotional functioning, and communicating with physicians. It has been found to be reliable and valid and has been translated into other languages.

    Collected at enrollment, 6 weeks, and 3 months post treatment

  • Change in Life Space Assessment (LSA)

    Life Space Assessment (LSA) is a self-report measure that captures the extent and frequency of environmental mobility (life space) and participation of persons with mobility limitations. It includes assessment of the need for personal assistance and/or equipment. It has been found to be a reliable and valid measure in persons with SCI.

    Collected at enrollment, 6 weeks, and 3 months post treatment

  • Change in the Craig Handicap Assessment and Reporting Technique (CHART) Short Form

    The CHART is a reliable and valid assessment of participation and has been used frequently with individuals with SCI.

    Collected at enrollment, 6 weeks, and 3 months post treatment

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment arm will be enrolled in the SCI Thrive Peer-Led Online Self-Management program and will take part in the next available group session.

Behavioral: SCI Thrive Peer-Led Online Self-Management Program

Wait-list Control

NO INTERVENTION

Wait-list control arm will only complete assessments during the 6 week group period. Subjects will be offered a place in the SCI Thrive Peer-Led Online Self-Management program after 6 weeks and completing the assessments.

Interventions

6 week online course in self-management for individuals with spinal cord injuries. This was developed by a team using principles of cognitive behavioral techniques.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Online: Any Location
  • Spinal Cord Injury
  • Age \>= 18 years
  • English Speaking
  • Cognitively able to engage in the course and able to complete initial start-up requirements on the course website
  • Computer/Smartphone/Tablet with internet access

You may not qualify if:

  • Planned absence during the 6 week course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Regional Spinal Cord Injury System: University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jeanne Hoffman, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Department of Rehabilitation Medicine University of Washington School of Medicine

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 16, 2019

Study Start

October 1, 2019

Primary Completion

July 24, 2021

Study Completion

December 24, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

No plan to share IPD.

Locations