Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury

Phase 2

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT00148239
• Lead Sponsor: University of Pittsburgh

Brief Summary

The overall objective of this project is to test the efficacy of an innovative multi-component intervention aimed at reducing the risk for adverse health outcomes among caregivers of older survivors with spinal cord injury or disability, and to improve the well being of the spinal cord-injured survivor. In a three-group, randomized, controlled design providing access to information, resources, and support, we predict that the dual target approach will have a greater positive impact on both the caregiver and survivor than the caregiver-only approach, and that both active treatments will be superior with respect to caregiver outcomes than an information-only control condition.

Detailed Description

The specific aims of this project are to:

1. Assess the impact of a dual target (caregiver and care recipient) intervention compared to a traditional caregiver-only intervention strategy.

2. Assess causal linkages between the treatment components (e.g. knowledge, social support) of a multi-component intervention and specific treatment outcomes (e.g. caregiver depression, quality of life).

3. Explore cultural and racial differences in the evaluation of and effectiveness of the different treatment approaches.

Overall, the issues affecting management of SCI/D in later life are complex and hold critical implications for the health of the long-term survivor as well as for those who provide care in the home environment. Large numbers of individuals are living with the effects of SCI/D for decades post-injury. In addition to the health-related complications that typically accompany older age, these individuals are especially vulnerable to co-occurring medical conditions that require high degrees of support and maintenance. Consequently, older caregivers face multiple and often extreme challenges in providing support to the SCI/D survivor at a time in their lives when their own abilities may be compromised due to age-related changes in health and functioning.

The multi-faceted burden faced by caregivers is associated with high levels of depression and anxiety as well as the onset of deleterious physical symptoms. The cumulative effects of such multiple stressors over time all too frequently leave the caregiver unable to continue providing the level of support necessary to maintain their partner's health in the home environment. In order to circumvent the additional distress certain to accompany such a family separation, Elliott et al. (2001, p. 230) recently concluded that "there is a pressing need for interventions that help family \[SCI\] caregivers address the routines and tasks essential to maintaining family functioning."

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Primary Completion: 2007-07
• Study Completion: 2008-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Not provided

Exclusion Criteria

• has a terminal illness with life expectancy of less than 6 months
• is in active treatment for cancer (except for tamoxifen and lupron)
• is blind or deaf
• if the survivor is cognitively impaired due to brain injury or dementia and/or has no use of their hands and severe limitations in speech production

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive symptoms caregivers and SCI	6 and 12 months post-randomization
Caregiver Burden	6 and 12 months
Social support caregiver and SCI	6 and 12 months
Health symptoms caregiver and SCI	6 and 12 months

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Miami, Florida, United States

University of Pittsburgh (UCSUR); 🇺🇸 Pittsburgh, Pennsylvania, United States