StrokePhase 3NCT00037492
Families In Recovery From Stroke Trial (F.I.R.S.T.)
A Phase 3 study testing home-based sessions/family meetings with trained clinician in people with Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 6 sites in United States.
Trial summary
The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- home-based sessions/family meetings with trained clinician
- Type of treatment
- Surgery or procedure
- How many people
- 291 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Youville Rehabilitation Hospital
Cambridge, Massachusetts, 02138
Mount Auburn Hospital
Cambridge, Massachusetts, 02238
About this study
Official title: Psychological Intervention in Stroke Recovery
The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.
Read the 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.
- Conditions
- Stroke
- Being tested
- home-based sessions/family meetings with trained clinician
- Keywords
- stroke, recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based sessions/family meetings with trained clinicianProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 291 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Lisa Berkman, PhD, Principal investigator, Harvard School of Public Health, Department of Society, Human Development, and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037492
- Sponsor's protocol ID
- R01NS032324
- Status last verified
- May 2007
- First submitted
- 17 May 2002
- Last updated
- 22 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention in Stroke Recovery
- ClinicalTrials.gov ID
- NCT00037492
- Acronym / sponsor ID
- R01NS032324
- Conditions
- Stroke
- Keywords
- stroke, recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- First posted
- 20 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- patients living outside the greater Boston area;
- admitted from a nursing home;
- terminally ill;
- severely aphasic;
- significantly cognitively impaired;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based sessions/family meetings with trained clinician | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2007.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Berkman, PhD principal investigator
Harvard School of Public Health, Department of Society, Human Development, and Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing home-based sessions/family meetings with trained clinician in people with Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2007.