Spinal Cord InjuriesSCIThriveNCT04059718
SCI Thrive: Efficacy of a Peer-led Online Self-Management Program
A study testing SCI Thrive Peer-Led Online Self-Management Program in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SCI Thrive Peer-Led Online Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 24 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Planned absence during the 6 week course
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Regional Spinal Cord Injury System: University of Washington
Seattle, Washington, 98195
About this study
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.
Read the detailed description
With spinal cord injury (SCI), individuals are at a greater risk for a number of chronic health conditions. Research suggests that these health conditions reduce quality of life for individuals with SCI and decrease social engagement. Many of these health conditions are in fact preventable by early detection, behavioral changes, and early intervention.
Self-management programs have emerged as an adjunct to traditional health care services based management of chronic conditions. Self-management programs provide necessary knowledge, and skills, but ultimately focus on the central role of the individual in balancing medical management, maintaining life roles and community engagement, and managing emotional distress.
Beyond self-management strategies alone, more evidence now exists for increasing self-management and knowledge of health related resources for individuals with SCI through peer support. Face-to-face peer support programs have been found to improve self-efficacy and reduce the occurrence of medical complications. Additionally, peer support is positively associated with social participation and life satisfaction.
The purpose of this study is to determine if an online, peer led self-management program can lead to:
- An improvement in of quality of life for people with spinal cord injuries
- Increase in confidence in your ability to achieve goals (self-efficacy) and community participation
- Assess if improvements last 3 months after completion
- Evaluate participant satisfaction with the program and the materials
If you decide to take part in this study, you will first be asked to complete an online survey which should take about 20 minutes. You will then be randomized (like flipping a coin) in the treatment group or the control group. If you are in the treatment group, you will begin the online program. If you are in the control group, you will be asked to wait 6 weeks before beginning the program. After 6 weeks, both groups will take a second online survey. If you are in the control group, we will ask if you want to take part in the online program. If you do, you will have one additional survey upon completion of the online program. 3 months after completion of the online program, we will contact you to complete the final online survey. Each of these surveys should take approximately 15 minutes.
The first survey will ask some information about you and your background. The first survey and the last two will also ask questions about how you manage your health with a spinal cord injury, how satisfied you are in various aspects of your life, how much you get around, how you spend your time, and interact with people. Some of the most sensitive questions ask about satisfaction with income, relationships, and sexual activity. You may refuse to answer any question in the surveys.
When you take part in the online self-management program, you will work through a different educational module each week. These will include modules on goal setting, thinking strategies and distraction, alternative thoughts, problem solving and decision tools, communication and advocacy, applying to your own goals, and relaxations exercises for each session. Each module should take approximately 1 hour to complete.
During the 6 week program, there will be at lease three video/telephone conferences with the peer leader and the other participants. The goal of the weekly conference is for participants to discuss the materials, what aspects are working or not working for them, provide their individual perspectives, and support each other. These conferences will last no longer than 1 hour.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCI Thrive Peer-Led Online Self-Management 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.
SCI Thrive Peer-Led Online Self-Management ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected at enrollment, 6 weeks, and 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Oct 2019
- Primary completion24 Jul 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanne Hoffman, University of Washington
- Investigators
- Jeanne Hoffman, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059718
- Sponsor's protocol ID
- STUDY00006621
- Acronym
- SCIThrive
- Status last verified
- May 2022
- First submitted
- 12 Aug 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCI Thrive: Efficacy of a Peer-led Online Self-Management Program
- ClinicalTrials.gov ID
- NCT04059718
- Acronym / sponsor ID
- SCIThrive / STUDY00006621
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With spinal cord injury (SCI), individuals are at a greater risk for a number of chronic health conditions. Research suggests that these health conditions reduce quality of life for individuals with SCI and decrease social engagement. Many of these health conditions are in fact preventable by early detection, behavioral changes, and early intervention.
Self-management programs have emerged as an adjunct to traditional health care services based management of chronic conditions. Self-management programs provide necessary knowledge, and skills, but ultimately focus on the central role of the individual in balancing medical management, maintaining life roles and community engagement, and managing emotional distress.
Beyond self-management strategies alone, more evidence now exists for increasing self-management and knowledge of health related resources for individuals with SCI through peer support. Face-to-face peer support programs have been found to improve self-efficacy and reduce the occurrence of medical complications. Additionally, peer support is positively associated with social participation and life satisfaction.
The purpose of this study is to determine if an online, peer led self-management program can lead to:
- An improvement in of quality of life for people with spinal cord injuries
- Increase in confidence in your ability to achieve goals (self-efficacy) and community participation
- Assess if improvements last 3 months after completion
- Evaluate participant satisfaction with the program and the materials
If you decide to take part in this study, you will first be asked to complete an online survey which should take about 20 minutes. You will then be randomized (like flipping a coin) in the treatment group or the control group. If you are in the treatment group, you will begin the online program. If you are in the control group, you will be asked to wait 6 weeks before beginning the program. After 6 weeks, both groups will take a second online survey. If you are in the control group, we will ask if you want to take part in the online program. If you do, you will have one additional survey upon completion of the online program. 3 months after completion of the online program, we will contact you to complete the final online survey. Each of these surveys should take approximately 15 minutes.
The first survey will ask some information about you and your background. The first survey and the last two will also ask questions about how you manage your health with a spinal cord injury, how satisfied you are in various aspects of your life, how much you get around, how you spend your time, and interact with people. Some of the most sensitive questions ask about satisfaction with income, relationships, and sexual activity. You may refuse to answer any question in the surveys.
When you take part in the online self-management program, you will work through a different educational module each week. These will include modules on goal setting, thinking strategies and distraction, alternative thoughts, problem solving and decision tools, communication and advocacy, applying to your own goals, and relaxations exercises for each session. Each module should take approximately 1 hour to complete.
During the 6 week program, there will be at lease three video/telephone conferences with the peer leader and the other participants. The goal of the weekly conference is for participants to discuss the materials, what aspects are working or not working for them, provide their individual perspectives, and support each other. These conferences will last no longer than 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: SCI Thrive Peer-Led Online Self-Management ProgramTreatment arm will be enrolled in the SCI Thrive Peer-Led Online Self-Management program and will take part in the next available group session. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Planned absence during the 6 week course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCI Thrive Peer-Led Online Self-Management Program6 week online course in self-management for individuals with spinal cord injuries. This was developed by a team using principles of cognitive behavioral techniques. | Behavioural | Treatment |
Primary outcome
Change in Perceived Quality of Life Scale (PQOL)
Time frame: Collected at enrollment, 6 weeks, and 3 months post treatment
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.
Change in Self-Efficacy for Managing Chronic Disease 6-item Scale (SMCD)
Time frame: Collected at enrollment, 6 weeks, and 3 months post treatment
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.
Change in Life Space Assessment (LSA)
Time frame: Collected at enrollment, 6 weeks, and 3 months post treatment
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.
Change in the Craig Handicap Assessment and Reporting Technique (CHART) Short Form
Time frame: Collected at enrollment, 6 weeks, and 3 months post treatment
The CHART is a reliable and valid assessment of participation and has been used frequently with individuals with SCI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Hoffman, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCI Thrive Peer-Led Online Self-Management Program in people with Spinal Cord Injuries, run by University of Washington 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 6 inclusion and 1 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 17 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?
Change in Perceived Quality of Life Scale (PQOL) (time frame: Collected at enrollment, 6 weeks, and 3 months post treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022; AzTrials last refreshed its copy on 2 Nov 2026.