Clinical trial NCT01275495: Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Official title: Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-01-12
Enrollment: 254
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
timeFrame: Change in depressive symptoms from baseline to 8 weeks
measure: Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
timeFrame: Change in caregiving-related negative life changes from baseline to 8 weeks
measure: Unhealthy days: Unhealthy Days (UD)
timeFrame: Change in unhealthy days from baseline to 8 weeks
Secondary outcomes:
measure: Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)
timeFrame: Change in task difficulty from baseline to 8 weeks
measure: Optimism: Revised Life Orientation Test (LOT-R)
timeFrame: Change in optimism from baseline to 8 weeks
measure: Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)
timeFrame: Change in threat appraisal from baseline to 8 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Nursing
state: Indiana
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.