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Telephone Assessment and Skill-Building Intervention for Stroke Caregivers (TASKII)

Primary Purpose

Stroke, Family Caregivers

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telephone Assessment and Skill-Building Kit (TASK II)
Information, Support, and Referral (ISR)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Family Caregivers, Cerebrovascular Accident, Carers, Care Givers, Depression, Life change events, Family health, Quality of life, Cost, Intervention studies, Clinical trial

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Primary caregiver (unpaid family member or significant other) of a stroke survivor
  • No more than 8 weeks after survivor discharged home
  • Plans to be providing care for 1 year or longer
  • Access to a telephone
  • Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points

Exclusion Criteria:

  • Caregiver or survivor age < 21 years
  • Caregiver denies that survivor has had a stroke
  • Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke
  • Caregiver has low task difficulty (OCBS task difficulty score < 16)
  • Caregiver communication difficulties (e.g., hearing loss)
  • Caregiver not fluent in the English language
  • Caregiver 6-item MMSE score less than 4
  • Survivor residing in a nursing home or long-term care facility
  • Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis)
  • Survivor or caregiver history of hospitalization for alcohol or drug abuse
  • Survivor or caregiver history of severe mental illness (e.g., Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, schizophrenia)
  • Survivor or caregiver pregnancy
  • Survivor or caregiver is a prisoner or on house arrest

Sites / Locations

  • Indiana University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telephone Assessment and Skill-Building Kit (TASK II)

Information, Support, and Referral (ISR)

Arm Description

The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns.

The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks.

Outcomes

Primary Outcome Measures

Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Caregivers randomized to the TASK II group will have a greater reduction in caregiving-related negative life changes compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Unhealthy days: Unhealthy Days (UD)
Caregivers randomized to the TASK II group will have a greater reduction in unhealthy days compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.

Secondary Outcome Measures

Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)
Caregivers randomized to the TASK II group will have a greater reduction in task difficulty compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Optimism: Revised Life Orientation Test (LOT-R)
Caregivers randomized to the TASK II group will have a greater increase in optimism compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)
Caregivers randomized to the TASK II group will have a greater reduction in threat appraisal compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.

Full Information

First Posted
January 10, 2011
Last Updated
March 30, 2015
Sponsor
Indiana University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01275495
Brief Title
Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Acronym
TASKII
Official Title
Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Family Caregivers
Keywords
Stroke, Family Caregivers, Cerebrovascular Accident, Carers, Care Givers, Depression, Life change events, Family health, Quality of life, Cost, Intervention studies, Clinical trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Assessment and Skill-Building Kit (TASK II)
Arm Type
Experimental
Arm Description
The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns.
Arm Title
Information, Support, and Referral (ISR)
Arm Type
Active Comparator
Arm Description
The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Assessment and Skill-Building Kit (TASK II)
Intervention Type
Behavioral
Intervention Name(s)
Information, Support, and Referral (ISR)
Primary Outcome Measure Information:
Title
Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
Description
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Time Frame
Change in depressive symptoms from baseline to 8 weeks
Title
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Description
Caregivers randomized to the TASK II group will have a greater reduction in caregiving-related negative life changes compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Time Frame
Change in caregiving-related negative life changes from baseline to 8 weeks
Title
Unhealthy days: Unhealthy Days (UD)
Description
Caregivers randomized to the TASK II group will have a greater reduction in unhealthy days compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Time Frame
Change in unhealthy days from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)
Description
Caregivers randomized to the TASK II group will have a greater reduction in task difficulty compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Time Frame
Change in task difficulty from baseline to 8 weeks
Title
Optimism: Revised Life Orientation Test (LOT-R)
Description
Caregivers randomized to the TASK II group will have a greater increase in optimism compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Time Frame
Change in optimism from baseline to 8 weeks
Title
Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)
Description
Caregivers randomized to the TASK II group will have a greater reduction in threat appraisal compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Time Frame
Change in threat appraisal from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary caregiver (unpaid family member or significant other) of a stroke survivor No more than 8 weeks after survivor discharged home Plans to be providing care for 1 year or longer Access to a telephone Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points Exclusion Criteria: Caregiver or survivor age < 21 years Caregiver denies that survivor has had a stroke Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke Caregiver has low task difficulty (OCBS task difficulty score < 16) Caregiver communication difficulties (e.g., hearing loss) Caregiver not fluent in the English language Caregiver 6-item MMSE score less than 4 Survivor residing in a nursing home or long-term care facility Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis) Survivor or caregiver history of hospitalization for alcohol or drug abuse Survivor or caregiver history of severe mental illness (e.g., Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, schizophrenia) Survivor or caregiver pregnancy Survivor or caregiver is a prisoner or on house arrest
Facility Information:
Facility Name
Indiana University School of Nursing
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21139466
Citation
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.
Results Reference
background
PubMed Identifier
19581197
Citation
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.
Results Reference
background
PubMed Identifier
19941582
Citation
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.
Results Reference
background
PubMed Identifier
34813082
Citation
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.
Results Reference
derived
PubMed Identifier
26549488
Citation
Bakas T, Austin JK, Habermann B, Jessup NM, McLennon SM, Mitchell PH, Morrison G, Yang Z, Stump TE, Weaver MT. Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial. Stroke. 2015 Dec;46(12):3478-87. doi: 10.1161/STROKEAHA.115.011099. Epub 2015 Nov 8.
Results Reference
derived
PubMed Identifier
25952589
Citation
McLennon SM, Hancock RD, Redelman K, Scarton LJ, Riley E, Sweeney B, Habermann B, Jessup NM, Bakas T. Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers. Clin Rehabil. 2016 May;30(5):495-507. doi: 10.1177/0269215515585134. Epub 2015 May 7.
Results Reference
derived
PubMed Identifier
25141098
Citation
Jessup NM, Bakas T, McLennon SM, Weaver MT. Are there gender, racial or relationship differences in caregiver task difficulty, depressive symptoms and life changes among stroke family caregivers? Brain Inj. 2015;29(1):17-24. doi: 10.3109/02699052.2014.947631. Epub 2014 Aug 20.
Results Reference
derived
PubMed Identifier
24858447
Citation
McLennon SM, Bakas T, Jessup NM, Habermann B, Weaver MT. Task difficulty and life changes among stroke family caregivers: relationship to depressive symptoms. Arch Phys Med Rehabil. 2014 Dec;95(12):2484-90. doi: 10.1016/j.apmr.2014.04.028. Epub 2014 May 22.
Results Reference
derived

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Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

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