Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148239
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2005-09-02
Brief Title:
Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Caregiver Intervention for Caregivers of SCI Patients
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCI
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 eg knowledge social support of a multi-component intervention and specific treatment outcomes eg 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 SCID 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 SCID 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 SCID 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 partners 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 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 eg knowledge social support of a multi-component intervention and specific treatment outcomes eg 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 SCID 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 SCID 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 SCID 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 partners 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None