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Intervention for Stroke Survivors and Their Spousal Caregivers

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation, Counseling and Skill Training
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebrovascular Accident focused on measuring Stroke, Caregivers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient experienced a stroke within the last year Age 50 or older Going home with a spouse or committed partner Needs daily assistance Live within 50 miles fo the TMC Can be reached by telephone Able to understand English - Exclusion Criteria: Admitted from or being discharged to a nursing home Disability requiring total assistance Lethargic, obtunded or comatose Other significant CNS disease (ie, severe Parkinson's) Severe psychopathology Globally aphasic Other major illness that would interfere with rehabilitation (ie, advanced cancer) -

Sites / Locations

  • University of Texas Health Science Center at Houston

Outcomes

Primary Outcome Measures

Stroke survivor function
Stroke survivor and caregiver quality of life
Stroke survivor and caregiver stress
Stroke survivor and caregiver depression
Service utilization
Cytokine levels of caregivers

Secondary Outcome Measures

Family coping styles
Social support system
Caregiver preparation
Marital relationship

Full Information

First Posted
September 12, 2005
Last Updated
November 3, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University, Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00178529
Brief Title
Intervention for Stroke Survivors and Their Spousal Caregivers
Official Title
Intervention for Stroke Survivors and Their Spousal Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University, Baylor College of Medicine

4. Oversight

5. Study Description

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 (i.e., 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke, Caregivers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation, Counseling and Skill Training
Primary Outcome Measure Information:
Title
Stroke survivor function
Title
Stroke survivor and caregiver quality of life
Title
Stroke survivor and caregiver stress
Title
Stroke survivor and caregiver depression
Title
Service utilization
Title
Cytokine levels of caregivers
Secondary Outcome Measure Information:
Title
Family coping styles
Title
Social support system
Title
Caregiver preparation
Title
Marital relationship

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient experienced a stroke within the last year Age 50 or older Going home with a spouse or committed partner Needs daily assistance Live within 50 miles fo the TMC Can be reached by telephone Able to understand English - Exclusion Criteria: Admitted from or being discharged to a nursing home Disability requiring total assistance Lethargic, obtunded or comatose Other significant CNS disease (ie, severe Parkinson's) Severe psychopathology Globally aphasic Other major illness that would interfere with rehabilitation (ie, advanced cancer) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon K. Ostwald, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived

Learn more about this trial

Intervention for Stroke Survivors and Their Spousal Caregivers

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