Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury
NCT ID: NCT00148239
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
380 participants
INTERVENTIONAL
2002-09-30
2008-07-31
Brief Summary
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Detailed Description
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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."
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Caregiver Only
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.
Caregiver Only Intervention
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.
Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Control
Participants are provided with written materials at beginning of study; nothing thereafter
Control
Participants given written educational materials at beginning of study; no treatment beyond this
Interventions
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Caregiver Only Intervention
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.
Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Control
Participants given written educational materials at beginning of study; no treatment beyond this
Eligibility Criteria
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Inclusion Criteria
* be survivors with complete or incomplete injury as defined by the American Spinal Injury Association (ASIA) impairment scale
* require and use some type of assistance for getting around (e.g., wheelchair, cane, etc.) be 30 years old or older be living at home for a minimum of 1 year post-injury (to avoid the acute trauma phase) speak English.
* Is a family member/partner (e.g. spouse, child, or fictive kin)
* is 18 years of age or older
* is or is not living with the care recipient
* speaks English
* has a telephone at home
* plans to live in the area for at least 6 months.
* self-identifies as white, African American or Hispanic.
Exclusion Criteria
* 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
30 Years
ALL
No
Sponsors
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University of Miami
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Richard Schulz
Prof. of Psychiatry
Principal Investigators
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Richard Schulz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Miami
Miami, Florida, United States
University of Pittsburgh (UCSUR)
Pittsburgh, Pennsylvania, United States
Countries
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References
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Schulz R, Czaja SJ, Lustig A, Zdaniuk B, Martire LM, Perdomo D. Improving the quality of life of caregivers of persons with spinal cord injury: a randomized controlled trial. Rehabil Psychol. 2009 Feb;54(1):1-15. doi: 10.1037/a0014932.
Other Identifiers
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