Families In Recovery From Stroke Trial (F.I.R.S.T.)

May 21, 2007 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

Psychological Intervention in Stroke Recovery

The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prior research shows that, after a stroke, emotional support from friends and family is very important in recovery from stroke. This study was designed to test whether a program of family sessions would lead to a faster recovery for stroke patients and lower stress for their families. The sessions were designed to mobilize the family and close friends of a stroke patient and help them to provide effective support to the patient. The aim of the study was to help patients who have recently had a stroke to achieve greater functional ability. Participants were randomly assigned to either the standard care or the treatment group. Those in the treatment group received standard care plus a maximum of 16 home-based sessions, or family meetings, with a specially-trained clinician. (The majority of participants received 14 or 15 sessions.) The sessions included stroke education, information about services and community resources, assistance with problem solving to aid in gaining independence, help with coping, and emotional support. The study is no longer enrolling patients and the study data has been collected. The data is now being analyzed.

Study Type

Interventional

Enrollment

291

Phase

  • Phase 3

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02114
        • Spaulding Rehabilitation Hospital
      • Cambridge, Massachusetts, United States, 02138
        • Youville Rehabilitation Hospital
      • Cambridge, Massachusetts, United States, 02238
        • Mount Auburn Hospital

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • patients with ischemic stroke or non-traumatic intracerebral hemorrhage, with residual deficit origin;
  • age 45 or older
  • stroke severity (3-8 on the NIH stroke severity scale); and
  • able to participate in the intervention (due to, for example, ability to communicate or level of social connectedness).

Exclusion:

  • patients living outside the greater Boston area;
  • admitted from a nursing home;
  • terminally ill;
  • severely aphasic;
  • significantly cognitively impaired;
  • unable to speak English; and
  • under 45 years of age.

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: Prevention
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Lisa Berkman, PhD, Harvard School of Public Health, Department of Society, Human Development, and Health

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 Registration Dates

First Submitted

May 17, 2002

First Submitted That Met QC Criteria

May 17, 2002

First Posted (Estimate)

May 20, 2002

Study Record Updates

Last Update Posted (Estimate)

May 22, 2007

Last Update Submitted That Met QC Criteria

May 21, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NS032324 (U.S. NIH Grant/Contract)

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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