Spinal Cord Injuries and Disorders (SCI/D)
Conditions
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.
Interventions
OTHERCaring Connections
peer-based letter writing social connectedness intervention to improve social health outcomes
OTHERAttention control
informational materials provided to educate on life domains that are important to social health
Sponsors
Chicago Association for Research and Education in Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled trial comparing intervention with attention control condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| loneliness | change from baseline to post-RCT (6 months) | UCLA 3-item Loneliness Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| social isolation | change from baseline to post-RCT (6 months) | PROMIS Social Isolation 8-item |
Other
| Measure | Time frame | Description |
|---|---|---|
| perceived benefit from the intervention | post-RCT at 6 months | 5-point Likert scale (No benefit, Minor benefit, Neutral, Moderate benefit, Major benefit) |
| social contact with friends/family | 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) |
| satisfaction with the intervention | post-RCT at 6 months | 5-point Likert scale (Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied) |
| perceived negative impacts from the intervention | post-RCT at 6 months | 5-point Likert scale (No negative impacts, Minor negative impacts, Neutral, Moderate negative impacts, Major negative impacts) |
| 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) | 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) |
Countries
United States
Outcome results
None listed