Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring Connections | Other | peer-based letter writing social connectedness intervention to improve social health outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| loneliness | UCLA 3-item Loneliness Scale | change from baseline to post-RCT (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| social isolation | PROMIS Social Isolation 8-item | change from baseline to post-RCT (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| social contact with friends/family | 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) | 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.) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherri LaVela, PhD, MPH, MBA | Department of Veterans Affairs, Hines VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hines VA | Hines | Illinois | 60141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41021480 | Derived | 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. 2026 May;71(2):149-160. doi: 10.1037/rep0000637. Epub 2025 Sep 29. | |
| 36400737 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized controlled trial comparing intervention with attention control condition.
Not provided
Not provided
Not provided
Not provided
| Attention control | Other | informational materials provided to educate on life domains that are important to social health |
|
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) |
| change from baseline to post-RCT (6 months) |
| perceived benefit from the intervention | 5-point Likert scale (No benefit, Minor benefit, Neutral, Moderate benefit, Major benefit) | post-RCT at 6 months |
| perceived negative impacts from the intervention | 5-point Likert scale (No negative impacts, Minor negative impacts, Neutral, Moderate negative impacts, Major negative impacts) | post-RCT at 6 months |
| satisfaction with the intervention | 5-point Likert scale (Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied) | post-RCT at 6 months |
| 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. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided