A Phase 2/3 interventional study of Caregiver Only Intervention and Dual Treatment in Spinal Cord Injuries, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Pittsburgh · Phase 2/3, Interventional, and Treatment
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.
The specific aims of this project are to:
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."
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 380 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Survivors):
Inclusion Criteria (Caregivers):
Exclusion Criteria:
A multi-component psycho-educational intervention designed to reduce the negative emotional and behavioral responses of the caregiver and reduce the risk of mental and physical health problems.
Behavioral: Caregiver Only Intervention
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Behavioral: Dual Treatment
Participants are provided with written materials at beginning of study; nothing thereafter
Behavioral: Control
A multi-component psycho-educational intervention designed to reduce the negative emotional and behavioral responses of the caregiver and reduce the risk of mental and physical health problems.
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Participants given written educational materials at beginning of study; no treatment beyond this
Depressive symptoms caregivers and SCI
Time frame: 6 and 12 months post-randomization
Caregiver Burden
Time frame: 6 and 12 months
Social support caregiver and SCI
Time frame: 6 and 12 months
Health symptoms caregiver and SCI
Time frame: 6 and 12 months
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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