Clinical trial NCT05295108: Caring Connections: A Program to Alleviate Social Isolation and Loneliness in Individuals Living With Spinal Cord Injury
Official title: Caring Connections: A Program to Alleviate Social Isolation and Loneliness in Individuals Living With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries and Disorders (SCI/D)
Lead sponsor: Chicago Association for Research and Education in Science
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing intervention with attention control condition.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: loneliness
timeFrame: change from baseline to post-RCT (6 months)
Secondary outcomes:
measure: social isolation
timeFrame: change from baseline to post-RCT (6 months)
Other outcomes:
measure: social contact with friends/family
timeFrame: change from baseline to post-RCT (6 months)
measure: 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.)
timeFrame: change from baseline to post-RCT (6 months)
measure: perceived benefit from the intervention
timeFrame: post-RCT at 6 months
measure: perceived negative impacts from the intervention
timeFrame: post-RCT at 6 months
measure: satisfaction with the intervention
timeFrame: post-RCT at 6 months
Locations:
city: Hines
country: United States
facility: Hines VA
state: Illinois
Study officials:
affiliation: Department of Veterans Affairs, Hines VA
name: Sherri LaVela, PhD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.