Clinical trial NCT04059718: SCI Thrive: Efficacy of a Peer-led Online Self-Management Program
Official title: SCI Thrive: Efficacy of a Peer-led Online Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

1. An improvement in of quality of life for people with spinal cord injuries
2. Increase in confidence in your ability to achieve goals (self-efficacy) and community participation
3. Assess if improvements last 3 months after completion
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Planned absence during the 6 week course

Primary outcomes:
measure: Change in Perceived Quality of Life Scale (PQOL)
timeFrame: Collected at enrollment, 6 weeks, and 3 months post treatment
measure: Change in Self-Efficacy for Managing Chronic Disease 6-item Scale (SMCD)
timeFrame: Collected at enrollment, 6 weeks, and 3 months post treatment
measure: Change in Life Space Assessment (LSA)
timeFrame: Collected at enrollment, 6 weeks, and 3 months post treatment
measure: Change in the Craig Handicap Assessment and Reporting Technique (CHART) Short Form
timeFrame: Collected at enrollment, 6 weeks, and 3 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Northwest Regional Spinal Cord Injury System: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jeanne Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References: