Psychological Intervention in Stroke Recovery
The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.
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.
Status: Completed (Phase 3).
Enrollment: 291 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
Conditions:
Interventions:
- Procedure: home-based sessions/family meetings with trained clinician
Eligibility
Inclusion:
patients with ischemic stroke or non-traumatic intracerebral hemorrhage, with residual deficit origin;
age 45 or older
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.
- Gender
Both
- Mininum Age
45 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: National Institute of Neurological Disorders and Stroke (NINDS)
Authority: United States: Federal Government
Locations
-
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
-
Brigham and Women’s Hospital
Boston
Massachusetts
02115
United States
-
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
-
Mount Auburn Hospital
Cambridge
Massachusetts
02238
United States
-
Spaulding Rehabilitation Hospital
Boston
Massachusetts
02114
United States
-
Youville Rehabilitation Hospital
Cambridge
Massachusetts
02138
United States
Officials
Lisa Berkman, PhD (Principal Investigator, Harvard School of Public Health, Department of Society, Human Development, and Health)
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS) (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- May 1st, 2007
- First Received
- May 21st, 2007
- Last Changed
- May 21st, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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