Intervention for Stroke Survivors and Their Spousal Caregivers

November 3, 2020 updated by: The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Family coping styles
Social support system
Caregiver preparation
Marital relationship

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Baylor College of Medicine
Texas Woman's University

Investigators

  • Principal Investigator: Sharon K. Ostwald, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR035316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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