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Caring Connections for Spinal Cord Injury

N/A
Waitlist Available
Led By Sherri LaVela, PhD, MPH, MBA
Research Sponsored by Chicago Association for Research and Education in Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Veterans with SCI/D under the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-rct at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a program called Caring Connections to help reduce social isolation and loneliness in people with spinal cord injury or disorder (SCI/D). The program involves peer support, which has been shown to

Who is the study for?
This trial is for adult Veterans with chronic spinal cord injury/disorder (SCI/D) that's lasted more than a year. It includes various causes of SCI/D like trauma, non-cancerous tumors causing nerve issues, blood vessel problems in the spine, inflammation or demyelinating diseases affecting the spinal cord.
What is being tested?
The study tests 'Caring Connections,' a peer-based program aimed at reducing loneliness and social isolation among individuals with SCI/D. Participants are randomly placed into either this program or an active control group to compare outcomes.
What are the potential side effects?
Since 'Caring Connections' is a social support intervention rather than a medical treatment, it does not have physical side effects. However, emotional discomfort due to sharing personal experiences may occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a veteran under 18 with a spinal cord injury or disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-rct at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-rct at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
loneliness
Secondary study objectives
social isolation
Other study objectives
perceived benefit from the intervention
perceived negative impacts from the intervention
satisfaction with the intervention
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Caring Connections interventionExperimental Treatment1 Intervention
The Caring Connections intervention will consist of non-demanding, messages of care and concern delivered to individuals with SCI/D who had moderate to high social isolation and/or loneliness scores on the baseline survey. The caring messages will be in the form of structured, yet personalized mailed letters from one consistent peer with SCI/D, providing long-term and steady contact. Intervention participants will receive a letter every month over a 6-month period. Following a standardized set of principles, letters will contain cheerful expressions of care and micro-moments of positivity. The PI/Co-Is will provide a brief training and work with volunteer peers with SCI/D to write the letters.
Group II: Attention controlActive Control1 Intervention
We will mail informational materials to individuals with SCI/D in our control group at the same timepoints over 6 months as our intervention letter mailings. The informational materials will discuss life domains that are important to a good quality of life. Topics include community living, physical/healthy living, safety and security, social/spirituality, advocacy/engagement, and employment/volunteering. We will draw information for each topic from the Knowledge Translation Center SCI Factsheets (MSKTC 2021) and the LifeCourse Nexus library (2021).

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Who is running the clinical trial?

Chicago Association for Research and Education in ScienceLead Sponsor
Sherri LaVela, PhD, MPH, MBAPrincipal InvestigatorDepartment of Veterans Affairs, Hines VA
~27 spots leftby Oct 2025
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