Efficacy of a Family Telephone Intervention for Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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stroke telephone intervention

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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Family Intervention Telephone Tracking

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ivan W. Miller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01NS037840

Identifier Type: NIH

Identifier Source: org_study_id

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