NCT00031265

Brief Summary

The purpose of this trial is to determine if a family intervention administered by telephone to stroke patients and their caregivers increases adaptation and functioning after stroke.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for phase_2 stroke

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 1998

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2002

Completed
Last Updated

October 12, 2005

Status Verified

October 1, 2005

First QC Date

February 28, 2002

Last Update Submit

October 11, 2005

Conditions

Stroke

Keywords

stroketelephoneintervention

Interventions

Family Intervention Telephone TrackingPROCEDURE

Eligibility Criteria

Age36 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 35 years,
  • MRI or CAT scan proof of stroke or definitive hemiplegia, and
  • competency to sign an informed consent form.

You may not qualify if:

  • presence of subarachnoid hemorrhage, transient ischemic attack or subdural hematoma,
  • significant medical disorder severe enough to require hospitalization within the 3 months prior to stroke,
  • functional psychosis,
  • absence of a caregiver (anyone living within a 30 minute drive who is available and willing to attend to patient),
  • admitted from nursing home (since these patients are likely to return to the nursing home) and
  • inability to speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02769, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ivan W. Miller, Ph.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 28, 2002

First Posted

March 1, 2002

Study Start

October 1, 1998

Last Updated

October 12, 2005

Record last verified: 2005-10

Locations

US(1)