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

Spinal Cord Injuries Clinical Trial

— SCI  

Official title:

Caregiver Intervention for Caregivers of SCI Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148239
• Other study ID #: 5R01NR008272
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 2, 2005
• Last updated: November 30, 2015
• Start date: September 2002
• Est. completion date: July 2008

Study information

• Verified date: November 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: July 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh (UCSUR)	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms caregivers and SCI		6 and 12 months post-randomization	Yes
Primary	Caregiver Burden		6 and 12 months	No
Primary	Social support caregiver and SCI		6 and 12 months	No
Primary	Health symptoms caregiver and SCI		6 and 12 months	No