NCT00264745

Brief Summary

The purpose of this study is to test a new educational program for families taking care of persons who have had a stroke. Caregivers are asked what they think of the TASK program and how to make it better. After getting the TASK program, their ability to provide care will be compared with a group that did not receive the TASK program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 12, 2011

Status Verified

October 1, 2008

Enrollment Period

3.3 years

First QC Date

December 9, 2005

Last Update Submit

January 11, 2011

Conditions

Family Caregivers of Stroke SurvivorsStroke

Keywords

CaregiverStroke

Outcome Measures

Primary Outcomes (1)

  • To determine how useful the TASK program is for family caregivers; and to compare how difficult the caregiving tasks are for the caregivers, whether they feel depressed, and how they see their own health.

    baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 12 weeks.

Study Arms (2)

1

EXPERIMENTAL
Behavioral: TASK intervention

2

ACTIVE COMPARATOR
Behavioral: Attention Control

Interventions

TASK interventionBEHAVIORAL

The Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers.

1
Attention ControlBEHAVIORAL

Minimal intervention beyond initial hospital visit.

2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A family caregiver must (1) be an unpaid family member or friend of a stroke patient who has not been home from the hospital or nursing home more than 2 months, (2) be the main person who takes care of the stroke patient at home, (3) be able to read and speak English, (4) be able to talk and hear using the telephone, and (5) be willing to have 8 weekly calls from a nurse and 4 calls from a research assistant.

You may not qualify if:

  • We are unable to enroll caregivers or stroke survivors who (1) have a very serious illness and are expected to live no more than 6 months, (2) have severe mental illness, (3) have a history of alcohol or drug abuse, (4) are pregnant, (5) are prisoners or on house arrest, or (6) are living in a nursing home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

  • Bakas T, Li Y, Habermann B, McLennon SM, Weaver MT. Developing a cost template for a nurse-led stroke caregiver intervention program. Clin Nurse Spec. 2011 Jan-Feb;25(1):41-6. doi: 10.1097/NUR.0b013e318203cb92.

    PMID: 21139466RESULT

  • Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Content validity and satisfaction with a stroke caregiver intervention program. J Nurs Scholarsh. 2009;41(4):368-75. doi: 10.1111/j.1547-5069.2009.01282.x.

    PMID: 19941582RESULT

  • Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Top Stroke Rehabil. 2009 Mar-Apr;16(2):105-21. doi: 10.1310/tsr1602-105.

    PMID: 19581197RESULT

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

    PMID: 34813082DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tamilyn Bakas, RN, DNS

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 13, 2005

Study Start

June 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 12, 2011

Record last verified: 2008-10

Locations

US(1)