Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

NCT01275495 | Completed Phase 3

• 2 other identifiers: 1003-63R01NR010388
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (3)

• Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)

  Change in task difficulty from baseline to 8 weeks

• Optimism: Revised Life Orientation Test (LOT-R)

  Change in optimism from baseline to 8 weeks

• Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)

  Change in threat appraisal from baseline to 8 weeks

Study Arms (2)

Telephone Assessment and Skill-Building Kit (TASK II)

EXPERIMENTAL

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)

Information, Support, and Referral (ISR)

ACTIVE COMPARATOR

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)

Interventions

Telephone Assessment and Skill-Building Kit (TASK II) BEHAVIORAL

Telephone Assessment and Skill-Building Kit (TASK II)

Information, Support, and Referral (ISR) BEHAVIORAL

Information, Support, and Referral (ISR)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

Related Publications (9)

• 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: 21139466 BACKGROUND

• 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: 19581197 BACKGROUND

• 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: 19941582 BACKGROUND

• Kum C, Jones HJ, Miller EL, Kreitzer N, Bakas T. Theoretically Based Factors Associated With Stroke Family Caregiver Health. Rehabil Nurs. 2024 May-Jun 01;49(3):86-94. doi: 10.1097/RNJ.0000000000000458.

  PMID: 38696434 DERIVED

• 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: 34813082 DERIVED

• 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.

  PMID: 26549488 DERIVED

• 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.

  PMID: 25952589 DERIVED

• 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.

  PMID: 25141098 DERIVED

• 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.

  PMID: 24858447 DERIVED

MeSH Terms

Conditions

Stroke; Depression

Interventions

Palliative Care; Referral and Consultation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: May 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)