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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01275495
First received: January 10, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Family Caregivers
Behavioral: Telephone Assessment and Skill-Building Kit (TASK II)
Behavioral: Information, Support, and Referral (ISR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: Change in depressive symptoms from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in caregiving-related negative life changes from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in unhealthy days from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in task difficulty from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in optimism from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in threat appraisal from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 254
Study Start Date: May 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone Assessment and Skill-Building Kit (TASK II)
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.
Behavioral: Telephone Assessment and Skill-Building Kit (TASK II)
Active Comparator: Information, Support, and Referral (ISR)
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.
Behavioral: Information, Support, and Referral (ISR)

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275495

Locations
United States, Indiana
Indiana University School of Nursing
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
  More Information

Publications:
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01275495     History of Changes
Other Study ID Numbers: 1003-63, R01NR010388
Study First Received: January 10, 2011
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Stroke
Family Caregivers
Cerebrovascular Accident
Carers
Care Givers
Depression
Life change events
Family health
Quality of life
Cost
Intervention studies
Clinical trial

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014