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

Stroke Clinical Trial

Official title:

Psychological Intervention in Stroke Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037492
• Other study ID #: R01NS032324
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2002
• Last updated: May 21, 2007

Study information

• Verified date: May 2007
• Source: National Institute of Neurological Disorders and Stroke (NINDS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• home-based sessions/family meetings with trained clinician

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women’s Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts
United States	Mount Auburn Hospital	Cambridge	Massachusetts
United States	Youville Rehabilitation Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States,