Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178529
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2005-09-12
Brief Title:
Intervention for Stroke Survivors and Their Spousal Caregivers
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Intervention for Stroke Survivors and Their Spousal Caregivers
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an interdisciplinary intervention study with stroke survivors and their spousal caregivers after discharge from a rehabilitation unit It will determine whether couples receiving home visits from nurses and therapists over a 6 month period demonstrate better function and less psychological distress than couples who receive information by mail All couples are visited every 3 months by a nurse who assesses their physical and psychosocial functioning
Detailed Description:
This 5-year randomized intervention study uses an advanced practice nurse with the assistance of an interdisciplinary rehabilitation team to provide education support skill training counseling and social and community linkages to stroke survivors and their spouses for 6 months post-hospital discharge The intervention will be delivered using previously tested protocol guidelines Stroke survivors and their spousal caregivers will be assessed to determine whether or not the intervention is successful in 1 improving function quality of life and perceived health and decreasing depression in the stroke survivor 2 decreasing unplanned clinic and emergency room visits reducing rehospitalizations and admissions to nursing homes 3 decreasing depression burden stress and improving the health of spousal caregivers and 4 decreasing cytokine imbalances related to the chronic stress of caregiving among spouses Assessments will be made at baseline and at 3 6 9 and 12 months post-discharge on the stroke survivor and on the spousal caregiver by a nurse who is masked to the group assignment To determine the effect of the intervention on cytokine imbalance the researchers will 1 generate cytokines from cell cultures mitogen-induced and antigen specific T-cell lines and 2 analyze culture supernatants and plasma samples for their immunoregulatory cytokine content The laboratory technician and immunologist will be masked to the intervention group All covariates ie sociodemographic characteristics severity of the stroke dyadic relationships family functioning co-morbid health conditions etc will be evaluated to determine which are significantly related to the outcomes and only those will be included in the model Hierarchical Linear Models HLM will be used to model change over time for individual participants using a polynomial form Depending on the nature of the change function individual parameter estimates of the intercept slope and if necessary curvature will be compared across groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None