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

• ClinicalTrials.gov Identifier: NCT05295108
• Recruitment Status: Not yet recruiting
• First Posted: March 24, 2022
• Last Update Posted: February 8, 2023
• Sponsor: Chicago Association for Research and Education in Science
• Information provided by (Responsible Party): Sherri LaVela, Chicago Association for Research and Education in Science

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries and Disorders (SCI/D)	Other: Caring Connections; Other: Attention control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial comparing intervention with attention control condition.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Caring Connections: A Program to Alleviate Social Isolation and Loneliness in Individuals Living With Spinal Cord Injury
• Estimated Study Start Date: November 2023
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: April 29, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Caring Connections; peer-based letter writing social connectedness intervention to improve social health outcomes
Active Comparator: 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).	Other: Attention control; informational materials provided to educate on life domains that are important to social health

Outcome Measures

Primary Outcome Measures :

1. loneliness [ Time Frame: change from baseline to post-RCT (6 months) ]
   UCLA 3-item Loneliness Scale

Secondary Outcome Measures :

1. social isolation [ Time Frame: change from baseline to post-RCT (6 months) ]
   PROMIS Social Isolation 8-item

Other Outcome Measures:

1. social contact with friends/family [ Time Frame: change from baseline to post-RCT (6 months) ]
   frequency: Once a week, Several times a week, About once a month, Several times a year, About once or twice a year, Less than once a year, Never)
2. 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.) [ Time Frame: change from baseline to post-RCT (6 months) ]
   frequency: Once a week, Several times a week, About once a month, Several times a year, About once or twice a year, Less than once a year, Never)
3. perceived benefit from the intervention [ Time Frame: post-RCT at 6 months ]
   5-point Likert scale (No benefit, Minor benefit, Neutral, Moderate benefit, Major benefit)
4. perceived negative impacts from the intervention [ Time Frame: post-RCT at 6 months ]
   5-point Likert scale (No negative impacts, Minor negative impacts, Neutral, Moderate negative impacts, Major negative impacts)
5. satisfaction with the intervention [ Time Frame: post-RCT at 6 months ]
   5-point Likert scale (Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Sherri LaVela, PhD, MPH, MBA; 708-202-5895; sherri.lavela@va.gov

Sponsors and Collaborators

Chicago Association for Research and Education in Science

Investigators

• Principal Investigator: Sherri LaVela, PhD, MPH, MBA; Department of Veterans Affairs, Hines VA

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sherri LaVela, Research Health Scientist, Chicago Association for Research and Education in Science
• ClinicalTrials.gov Identifier: NCT05295108
• Other Study ID Numbers: 864046
• First Posted: March 24, 2022
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System