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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037492
First Posted: May 20, 2002
Last Update Posted: May 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
  Purpose
The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.

Condition Intervention Phase
Stroke Procedure: home-based sessions/family meetings with trained clinician Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Psychological Intervention in Stroke Recovery

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Estimated Enrollment: 291
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037492


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women’s Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Youville Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138
Mount Auburn Hospital
Cambridge, Massachusetts, United States, 02238
Sponsors and Collaborators
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
  More Information

ClinicalTrials.gov Identifier: NCT00037492     History of Changes
Other Study ID Numbers: R01NS032324 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2002
First Posted: May 20, 2002
Last Update Posted: May 22, 2007
Last Verified: May 2007

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
recovery

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases