Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-28 @ 12:19 PM
Study NCT ID:
NCT00037492
Status:
COMPLETED
Last Update Posted:
2007-05-22
First Post:
2002-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Families In Recovery From Stroke Trial (F.I.R.S.T.)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-21', 'studyFirstSubmitDate': '2002-05-17', 'studyFirstSubmitQcDate': '2002-05-17', 'lastUpdatePostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stroke', 'recovery'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* patients with ischemic stroke or non-traumatic intracerebral hemorrhage, with residual deficit origin;\n* age 45 or older\n* stroke severity (3-8 on the NIH stroke severity scale); and\n* able to participate in the intervention (due to, for example, ability to communicate or level of social connectedness).\n\nExclusion:\n\n* patients living outside the greater Boston area;\n* admitted from a nursing home;\n* terminally ill;\n* severely aphasic;\n* significantly cognitively impaired;\n* unable to speak English; and\n* under 45 years of age.'}, 'identificationModule': {'nctId': 'NCT00037492', 'briefTitle': 'Families In Recovery From Stroke Trial (F.I.R.S.T.)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Neurological Disorders and Stroke (NINDS)'}, 'officialTitle': 'Psychological Intervention in Stroke Recovery', 'orgStudyIdInfo': {'id': 'R01NS032324', 'link': 'https://reporter.nih.gov/quickSearch/R01NS032324', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'home-based sessions/family meetings with trained clinician', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Youville Rehabilitation Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '02238', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mount Auburn Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Lisa Berkman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health, Department of Society, Human Development, and Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}}}}