Clinical Trials Directory

Trials / Completed

CompletedNCT01275495

Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
254 (actual)
Sponsor
Indiana University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.

Detailed description

Stroke is the number one cause of disability in the United States, and over 4 million stroke survivors are alive today. Many stroke survivors need the help of a family caregiver. A family caregiver is a family member or close friend who helps the stroke survivor once they go home. Many caregivers need information and support during the first few months after the stroke survivor is discharged home. One group of caregivers will receive the TASK II intervention and another group of caregivers will receive existing educational materials about stroke and caregiving through an information, support, and referral (ISR) process. Both groups of caregivers will receive written materials about stroke and caregiving by mail and weekly telephone calls by a nurse for a total of 8 weeks, with an additional call at 12 weeks. A research assistant will also call by telephone at the beginning of the study, and at 8, 12, and 24 weeks after the beginning of the study, with a follow-up call at 1 year to interview both groups of caregivers about their caregiving activities and about their own health and well-being. If shown to be efficacious, our next goal will be to translate the TASK II intervention into practice settings to meet current recommendations and guidelines that emphasize follow up care for stroke survivors and their family caregivers.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTelephone Assessment and Skill-Building Kit (TASK II)
BEHAVIORALInformation, Support, and Referral (ISR)

Timeline

Start date
2010-05-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2011-01-12
Last updated
2015-03-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01275495. Inclusion in this directory is not an endorsement.