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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
home-based sessions/family meetings with trained clinician
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, recovery

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital
  • Spaulding Rehabilitation Hospital
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Youville Rehabilitation Hospital
  • Mount Auburn Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 17, 2002
Last Updated
May 21, 2007
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00037492
Brief Title
Families In Recovery From Stroke Trial (F.I.R.S.T.)
Official Title
Psychological Intervention in Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, recovery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Allocation
Randomized
Enrollment
291 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
home-based sessions/family meetings with trained clinician

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Berkman, PhD
Organizational Affiliation
Harvard School of Public Health, Department of Society, Human Development, and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Youville Rehabilitation Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02238
Country
United States

12. IPD Sharing Statement

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

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