Efficacy of a Family Telephone Intervention for Stroke

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031265
• Other study ID #: R01NS037840
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2002
• Last updated: October 11, 2005
• Start date: October 1998

Study information

• Verified date: October 2005
• Source: National Institute of Neurological Disorders and Stroke (NINDS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Family Intervention Telephone Tracking

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States,