Efficacy of a Family Telephone Intervention for Stroke

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00031265
First received: February 28, 2002
Last updated: October 11, 2005
Last verified: October 2005

February 28, 2002
October 11, 2005
October 1998
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Complete list of historical versions of study NCT00031265 on ClinicalTrials.gov Archive Site
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Efficacy of a Family Telephone Intervention for Stroke
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Stroke
Procedure: Family Intervention Telephone Tracking
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
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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.
Both
36 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00031265
R01NS37840
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Ivan W. Miller, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP