Caring Connections for Spinal Cord Injury

Overseen By Sherri LaVela, PhD, MPH, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chicago Association for Research and Education in Science

Disqualifiers: Under 18, New injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will use a randomized controlled design with an active attention control group to evaluate an intervention intended to reduce social isolation and loneliness in persons with SCI/D. The intervention, Caring Connections, is a peer-based intervention which is important because peers with SCI/D play an important role in improving quality of life, mental health, and social health in persons with SCI/D.

Research Team

Sherri LaVela, PhD, MPH, MBA

Principal Investigator

Department of Veterans Affairs, Hines VA

Eligibility Criteria

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.

Inclusion Criteria

I am a veteran with a long-term spinal cord injury or condition.

I am a veteran with a spinal cord injury or disease for over a year.

Exclusion Criteria

Individuals with new injuries (injury duration less than one year)

I am a veteran under 18 with a spinal cord injury or disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly letters from peers as part of the Caring Connections intervention to reduce social isolation and loneliness

6 months

Monthly mailings

Follow-up

Participants are monitored for changes in loneliness and social isolation outcomes after the intervention

4 weeks

Treatment Details

Interventions

• Attention control
• Caring Connections

Trial Overview 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.

Participant Groups

Group I: Caring Connections intervention Experimental Treatment 1 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 control Active Control 1 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).

Who Is Running the Clinical Trial?

Chicago Association for Research and Education in Science

Lead Sponsor

Trials

1

Recruited

60+