Caregiver Self-Management Needs Through Skill-Building
2 other identifiers
interventional
74
1 country
1
Brief Summary
Caring for a family member after a stroke can be very difficult and worsen the physical and mental health of untrained caregivers. The Telephone Assessment and Skill-Building Kit (TASK III) intervention is a unique, comprehensive caregiver intervention program that enables caregivers to develop the necessary skills to manage care for the survivor, while also taking care of themselves. The long-term goal of this study is to offer training and support for family caregivers through an efficacious, cost-effective program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2018
CompletedFirst Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
April 18, 2024
CompletedApril 18, 2024
March 1, 2024
3.2 years
July 24, 2018
February 25, 2024
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caregiver Satisfaction Ratings for Both TASK III and ISR Programs Measured by the Caregiver Satisfaction Scale (CSS).
Caregiver satisfaction ratings (usability, ease of use, acceptability) for both TASK III and ISR programs are measured using the Caregiver Satisfaction Scale (CSS). The CSS consists of 9 items rated on a response scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. Items are summed for a total score, then divided by 9 (number of items) with a possible range of 1 to 5. Higher scores indicate greater satisfaction.
12 weeks
Secondary Outcomes (3)
Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9).
Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Life Changes (i.e., Changes in Social Functioning, Subjective Well-being, and Physical Health as a Result of Providing Care) Measured by the Bakas Caregiving Outcomes Scale (BCOS).
Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Unhealthy Days Measured by the Number of Unhealthy Days in the Past 30 Days.
Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Study Arms (2)
TASK III Group
EXPERIMENTALThe Telephone Assessment and Skill-Building Kit (TASK III) group
ISR Group
ACTIVE COMPARATORThe Information, Support, and Referral (ISR) group
Interventions
The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.
The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Eligibility Criteria
You may qualify if:
- years or older
- Primary caregiver (unpaid family member or significant other providing care for a stroke survivor)
- Must be providing care after discharge to the home setting (for Specific Aim 2)
- Fluent in the English language
- Access to telephone or computer
- No difficulties hearing or talking by telephone or computer
- (Specific Aim 1) Willing to participate in an online or telephone focus group or an online or telephone individual interview. Some interviews or focus groups may be offered face to face.
- (Specific Aim 2) Willing to participate in 9 calls from a nurse and 3 data collection interviews.
You may not qualify if:
- Excluded if the survivor:
- Had not had a stroke
- Did not need help from the caregiver
- Was going to reside in a nursing home or long-term care facility
- Excluded if the caregiver:
- Scores \<16 on the Oberst Caregiving Burden Scale Task Difficulty Subscale (for Specific Aim 2)
- Scores \< 4 on a 6-item cognitive impairment screener.
- Excluded if the caregiver or survivor is:
- Prisoner or on house arrest
- Pregnant
- Terminal illness (e.g., late stage cancer, end-of-life condition, renal failure requiring dialysis)
- History of Alzheimer's, dementia, or severe mental illness (e.g., suicidal tendencies, schizophrenia, severe untreated depression or manic depressive disorder)
- History of hospitalization for alcohol or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati College of Nursing
Cincinnati, Ohio, 45219, United States
Related Publications (2)
Bakas T, McCarthy MJ, Israel J, Brehm BJ, Dunning K, Rota M, Turner M, Miller EL. Adapting the telephone assessment and skill-building kit to the telehealth technology preferences of stroke family caregivers. Res Nurs Health. 2021 Feb;44(1):81-91. doi: 10.1002/nur.22075. Epub 2020 Oct 19.
PMID: 33075163RESULTBakas T, Jones H, Israel J, Kum C, Miller EL. Designing and Evaluating a Goal-Setting Tip Sheet for Stroke Family Caregiver Health. Rehabil Nurs. 2021 Sep-Oct 01;46(5):279-288. doi: 10.1097/RNJ.0000000000000306.
PMID: 33512120RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tamilyn Bakas
- Organization
- University of Cincinnati College of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Tamilyn Bakas, PhD, RN
University of Cincinnati College of Nursing
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Jane E. Procter Endowed Chair
Study Record Dates
First Submitted
July 24, 2018
First Posted
August 17, 2018
Study Start
April 9, 2018
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
April 18, 2024
Results First Posted
April 18, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share