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

Phase 3

Completed

• Conditions: Stroke

• Registration Number: NCT00037492
• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Brief Summary

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

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 Timeline

• Study First Submitted: 2002-05-17
• Study First Submitted QC: 2002-05-17
• Study First Posted: 2002-05-20
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-21
• Last Update Posted: 2007-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Mount Auburn Hospital; 🇺🇸 Cambridge, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Youville Rehabilitation Hospital; 🇺🇸 Cambridge, Massachusetts, United States