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

NCT ID: NCT05295108

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2025-01-01

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.

Detailed Description

The overall study objective is to conduct and evaluate a fully powered randomized control trial (RCT) to assess changes in loneliness and social isolation outcomes between the Caring Connections intervention and attention control condition in community-dwelling individuals with SCI/D. The Caring Connections intervention (described in detail below) is a peer-based, facilitated, letter writing program designed to provide feelings of social connectedness and moments of positivity to reduce loneliness and social isolation in persons with SCI/D.

Conditions

Spinal Cord Injuries and Disorders (SCI/D)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Caring Connections 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 Type: EXPERIMENTAL

Caring Connections

Intervention Type: OTHER

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

Attention control

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).

Group Type: ACTIVE_COMPARATOR

Attention control

Intervention Type: OTHER

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

Interventions

Caring Connections

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

Intervention Type: OTHER

Attention control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Veterans with SCI/D under the age of 18 will be excluded. Individuals with new injuries (injury duration less than one year) will be excluded as it is plausible that social isolation and loneliness may more likely occur after the first year of injury when individuals have transitioned to the community and may no longer be surrounded by people consistently for help with their acute care needs (Dickson 2011). There are no SCI/D level or severity exclusions, as we wish to reach a diverse group of individuals.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chicago Association for Research and Education in Science

OTHER

Sponsor Role: lead

Responsible Party

Sherri LaVela

Research Health Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherri LaVela, PhD, MPH, MBA

Role: PRINCIPAL_INVESTIGATOR

Department of Veterans Affairs, Hines VA

Locations

Hines VA

Hines, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41021480 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36400737 (View on PubMed)

Other Identifiers

864046

Identifier Type: -

Identifier Source: org_study_id