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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Miami
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00148239
First received: September 2, 2005
Last updated: May 7, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Behavioral: Caregiver Only Intervention
Behavioral: Dual Treatment
Behavioral: Control
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caregiver Intervention for Caregivers of SCI Patients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Depressive symptoms caregivers and SCI [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: Yes ]
  • Caregiver Burden [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Social support caregiver and SCI [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Health symptoms caregiver and SCI [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 380
Study Start Date: September 2002
Estimated Study Completion Date: July 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Behavioral: Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
No Intervention: Control
Participants are provided with written materials at beginning of study; nothing thereafter
Behavioral: Control
Participants given written educational materials at beginning of study; no treatment beyond this

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 (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."

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148239

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Pennsylvania
University of Pittsburgh (UCSUR)
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
University of Miami
Investigators
Principal Investigator: Richard Schulz, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Richard Schulz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00148239     History of Changes
Other Study ID Numbers: 5 R01 NR08272
Study First Received: September 2, 2005
Last Updated: May 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
SCI
Caregiving
Aging
Disability
Paralysis

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014