NCT00037492

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P25-P50 for phase_3 stroke

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

May 17, 2002

Last Update Submit

May 21, 2007

Conditions

Stroke

Keywords

strokerecovery

Interventions

home-based sessions/family meetings with trained clinicianPROCEDURE

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Youville Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Mount Auburn Hospital

Cambridge, Massachusetts, 02238, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lisa Berkman, PhD

    Harvard School of Public Health, Department of Society, Human Development, and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

May 17, 2002

First Posted

May 20, 2002

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations

US(6)