Overview

This trial is active, not recruiting.

Condition spinal cord injuries
Treatments caregiver only intervention, dual treatment, control
Phase phase 2/phase 3
Sponsor University of Pittsburgh
Collaborator University of Miami
Start date September 2002
End date July 2007
Trial size 380 participants
Trial identifier NCT00148239, 5 R01 NR08272

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(Experimental)
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
(No Intervention)
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

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria (Survivors): - have adult-onset disability resulting from spinal cord injury, trauma, or disease, - 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. Inclusion Criteria (Caregivers): - 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: - 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

Additional Information

Official title Caregiver Intervention for Caregivers of SCI Patients
Principal investigator Richard Schulz, PhD
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."
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by University of Pittsburgh.