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

NCT ID: NCT00037492

Last Updated: 2007-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Interventions

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home-based sessions/family meetings with trained clinician

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role lead

Principal Investigators

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Lisa Berkman, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health, Department of Society, Human Development, and Health

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Youville Rehabilitation Hospital

Cambridge, Massachusetts, United States

Site Status

Mount Auburn Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01NS032324

Identifier Type: NIH

Identifier Source: org_study_id

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