Spinal Cord InjuriesPhase 2/3SCINCT00148239
Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury
A Phase 2/3 study testing Caregiver Only Intervention and Dual Treatment in people with Spinal Cord Injuries, run by University of Pittsburgh at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Caregiver Only Intervention and Dual Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Jul 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
University of Pittsburgh (UCSUR)
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Caregiver Intervention for Caregivers of SCI Patients
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.
Read the detailed description
The specific aims of this project are to:
- Assess the impact of a dual target (caregiver and care recipient) intervention compared to a traditional caregiver-only intervention strategy.
- 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).
- 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."
- Conditions
- Spinal Cord Injuries
- Being tested
- Caregiver Only Intervention, Dual Treatment, Control
- Keywords
- SCI, Caregiving, Aging, Disability, Paralysis
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Only InterventionBehavioural
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 TreatmentBehavioural
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
ControlBehavioural
Participants given written educational materials at beginning of study; no treatment beyond this
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Only | 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. Receives: Behavioral: Caregiver Only Intervention |
| Dual Treatment | Experimental | Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention Receives: Behavioral: Dual Treatment |
| Control | Active comparator | Participants are provided with written materials at beginning of study; nothing thereafter Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms caregivers and SCI
Measured: 6 and 12 months post-randomization
Caregiver Burden
Measured: 6 and 12 months
Social support caregiver and SCI
Measured: 6 and 12 months
Health symptoms caregiver and SCI
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Principal investigator, Richard Schulz, University of Pittsburgh
- Investigators
- Richard Schulz, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148239
- Sponsor's protocol ID
- 5R01NR008272
- Acronym
- SCI
- Status last verified
- Nov 2015
- First submitted
- 2 Sep 2005
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19618698
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Intervention for Caregivers of SCI Patients
- ClinicalTrials.gov ID
- NCT00148239
- Acronym / sponsor ID
- SCI / 5R01NR008272
- Conditions
- Spinal Cord Injuries
- Keywords
- SCI, Caregiving, Aging, Disability, Paralysis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Sep 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the impact of a dual target (caregiver and care recipient) intervention compared to a traditional caregiver-only intervention strategy.
- 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).
- 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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caregiver Only | Experimental | Behavioral: Caregiver Only InterventionA 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 | Experimental | Behavioral: Dual TreatmentComplements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention |
| Control | Active comparator | Behavioral: ControlParticipants are provided with written materials at beginning of study; nothing thereafter |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver Only InterventionA 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. | Behavioural | Caregiver Only |
| Dual TreatmentComplements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention | Behavioural | Dual Treatment |
| ControlParticipants given written educational materials at beginning of study; no treatment beyond this | Behavioural | Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Results publication: PubMed 19618698Schulz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Schulz, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Caregiver Only Intervention and Dual Treatment in people with Spinal Cord Injuries, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms caregivers and SCI (time frame: 6 and 12 months post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.