Clinical trial NCT00037492: Families In Recovery From Stroke Trial (F.I.R.S.T.)
Official title: Psychological Intervention in Stroke Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
recovery
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sponsor class: NIH
First posted: 2002-05-20
Enrollment: 291
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Cambridge
country: United States
facility: Youville Rehabilitation Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health, Department of Society, Human Development, and Health
name: Lisa Berkman, PhD
role: PRINCIPAL_INVESTIGATOR
References: