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

Psychological Intervention in Stroke Recovery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00037492
Enrollment
291
Registered
2002-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2007-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, recovery

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.

Interventions

PROCEDUREhome-based sessions/family meetings with trained clinician

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026