Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury
SCI
Caregiver Intervention for Caregivers of SCI Patients
1 other identifier
interventional
380
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2002
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedDecember 2, 2015
November 1, 2015
4.8 years
September 2, 2005
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Depressive symptoms caregivers and SCI
6 and 12 months post-randomization
Caregiver Burden
6 and 12 months
Social support caregiver and SCI
6 and 12 months
Health symptoms caregiver and SCI
6 and 12 months
Study Arms (3)
Caregiver Only
EXPERIMENTALA 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
EXPERIMENTALComplements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Control
ACTIVE COMPARATORParticipants are provided with written materials at beginning of study; nothing thereafter
Interventions
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.
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
Participants given written educational materials at beginning of study; no treatment beyond this
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- University of Miamicollaborator
Study Sites (2)
University of Miami
Miami, Florida, 33136, United States
University of Pittsburgh (UCSUR)
Pittsburgh, Pennsylvania, 15260, United States
Related 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. doi: 10.1037/a0014932.
PMID: 19618698RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Schulz, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. of Psychiatry
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
September 1, 2002
Primary Completion
July 1, 2007
Study Completion
July 1, 2008
Last Updated
December 2, 2015
Record last verified: 2015-11