Caring Connections: A Program to Alleviate Social Isolation and Loneliness in Individuals Living With Spinal Cord Injury

NCT05295108 | Completed

• 1 other identifier: 864046
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries and Disorders (SCI/D)

Outcome Measures

Primary Outcomes (1)

• loneliness

  UCLA 3-item Loneliness Scale

  change from baseline to post-RCT (6 months)

Secondary Outcomes (1)

• social isolation

  change from baseline to post-RCT (6 months)

Other Outcomes (5)

• social contact with friends/family

  change from baseline to post-RCT (6 months)

• social contact with organized groups (Examples include: a choir, a committee or board, a support group, a sports or exercise group, a hobby group, or a professional society.)

  change from baseline to post-RCT (6 months)

• perceived benefit from the intervention

  post-RCT at 6 months

Study Arms (2)

Caring Connections intervention

EXPERIMENTAL

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.

Other: Caring Connections

Attention control

ACTIVE COMPARATOR

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).

Other: Attention control

Interventions

Caring Connections OTHER

peer-based letter writing social connectedness intervention to improve social health outcomes

Caring Connections intervention

Attention control OTHER

informational materials provided to educate on life domains that are important to social health

Attention control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Our target population will include adult Veterans with chronic SCI/D (duration of injury \> 1 year); this may include those with traumatic and non-traumatic SCI/D, and may include SCI, nonmalignant neoplasms resulting in neurologic deficit; vascular insults of a thromboembolic, hemorrhagic, or ischemic nature; cauda equina syndrome producing neurologic deficit; inflammatory disease of the spine, spinal cord, or cauda equina resulting in non-progressive neurologic deficit; and demyelinating disease of the spinal cord.

Sponsors & Collaborators

• Chicago Association for Research and Education in Science: lead

Study Sites (1)

Hines VA

Hines, Illinois, 60141, United States

Location

Related Publications (2)

• LaVela SL, Wirth M, Berryman K, Motl RW, Bartle B, Jacob RL, Aguina K, Bombardier CH. A randomized controlled trial of the Caring Connections intervention to reduce loneliness in persons with spinal cord injuries and disorders. Rehabil Psychol. 2025 Sep 29. doi: 10.1037/rep0000637. Online ahead of print.

  PMID: 41021480 DERIVED

• LaVela SL, Motl RW, Gonzalez B, Tarlov E, Aguina K, Bombardier CH. Randomised controlled trial of the Caring Connections intervention to reduce loneliness and perceived social isolation in persons with spinal cord injuries and disorders: study protocol. BMJ Open. 2022 Nov 18;12(11):e063246. doi: 10.1136/bmjopen-2022-063246.

  PMID: 36400737 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sherri LaVela, PhD, MPH, MBA

  Department of Veterans Affairs, Hines VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Model Details: Randomized controlled trial comparing intervention with attention control condition.

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 24, 2022
• Study Start: June 22, 2023
• Primary Completion: August 21, 2024
• Study Completion: January 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)