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Completed

NCT Number: NCT00037492

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

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

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

home-based sessions/family meetings with trained clinician

Procedure

Sponsors and collaborators

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Nih

Registry information

Official study title

Psychological Intervention in Stroke Recovery

Important dates

First posted
May 20, 2002
Registry last updated
May 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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