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Efficacy of a Family Telephone Intervention for Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031265
Recruitment Status : Completed
First Posted : March 1, 2002
Last Update Posted : October 12, 2005
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

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.

Condition or disease Intervention/treatment Phase
Stroke Procedure: Family Intervention Telephone Tracking Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 290 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : October 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031265

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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02769
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Ivan W. Miller, Ph.D.

Layout table for additonal information Identifier: NCT00031265    
Other Study ID Numbers: R01NS037840 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2002    Key Record Dates
Last Update Posted: October 12, 2005
Last Verified: October 2005
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases