Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

Stroke Clinical Trial

— TASKII  

Official title:

Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275495
• Other study ID #: 1003-63
• Secondary ID: R01NR010388
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2011
• Last updated: March 30, 2015
• Start date: May 2010
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Family Caregivers
• Stroke

Intervention

Behavioral:
• Telephone Assessment and Skill-Building Kit (TASK II)

• Information, Support, and Referral (ISR)

Locations

Country	Name	City	State
United States	Indiana University School of Nursing	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in depressive symptoms from baseline to 8 weeks	No
Primary	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.	Change in caregiving-related negative life changes from baseline to 8 weeks	No
Primary	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.	Change in unhealthy days from baseline to 8 weeks	No
Secondary	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.	Change in task difficulty from baseline to 8 weeks	No
Secondary	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.	Change in optimism from baseline to 8 weeks	No
Secondary	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.	Change in threat appraisal from baseline to 8 weeks	No