- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00148239
Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury (SCI)
Caregiver Intervention for Caregivers of SCI Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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."
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- University of Miami
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15260
- University of Pittsburgh (UCSUR)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
|
Experimentell: Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
|
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
|
Aktiv komparator: Control
Participants are provided with written materials at beginning of study; nothing thereafter
|
Participants given written educational materials at beginning of study; no treatment beyond this
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Depressive symptoms caregivers and SCI
Tidsram: 6 and 12 months post-randomization
|
6 and 12 months post-randomization
|
Caregiver Burden
Tidsram: 6 and 12 months
|
6 and 12 months
|
Social support caregiver and SCI
Tidsram: 6 and 12 months
|
6 and 12 months
|
Health symptoms caregiver and SCI
Tidsram: 6 and 12 months
|
6 and 12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Richard Schulz, PhD, University of Pittsburgh
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5R01NR008272 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
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produkt tillverkad i och exporterad från U.S.A.
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