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Efficacy of a Family Telephone Intervention for Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Family Intervention Telephone Tracking
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, telephone, intervention

Eligibility Criteria

36 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: age > 35 years, MRI or CAT scan proof of stroke or definitive hemiplegia, and competency to sign an informed consent form. Exclusion criteria: 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.

Sites / Locations

  • Rhode Island Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 28, 2002
Last Updated
October 11, 2005
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00031265
Brief Title
Efficacy of a Family Telephone Intervention for Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.
Detailed Description
Stroke is a major health problem which affects an estimated half million persons each year. In many cases family members assume the long-term burden of care after hospital discharge. Methods such as family education, peer support groups, and counseling are available to help meet the needs of caregivers, by enhancing their coping abilities. Family intervention also potentially benefits patients by improving the quality of caregiving skills. Few investigations have examined the benefits of family intervention methods. This trial will study the effectiveness of a family-based, telephone-administered intervention called Family Intervention: Telephone Tracking (FITT) for acute stroke patients and their caregivers. Study patients will be recruited from those admitted to the Rhode Island Hospital following an acute stroke. All patients and caregivers will receive standard medical care. In addition, these patients and their caregivers will be randomly assigned to one of two treatment conditions: FITT or no intervention. Treatments will begin once the patient returns home and will continue for a six-month period. During the trial, specially trained staff will carefully monitor the progress of the stroke patient and his/her family member, checking for changing in thinking, concentration, attention, memory, mood, and family functioning that sometimes occurs in stroke. Participants will be contacted by telephone every week for 6 weeks, then every 2 weeks for 2 months, and then monthly for 2 months. The telephone calls will check on how the participants are doing after discharge and will assist with questions and concerns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, telephone, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
290 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Family Intervention Telephone Tracking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: age > 35 years, MRI or CAT scan proof of stroke or definitive hemiplegia, and competency to sign an informed consent form. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan W. Miller, Ph.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02769
Country
United States

12. IPD Sharing Statement

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Efficacy of a Family Telephone Intervention for Stroke

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