Caregiver Self-Management Needs Through Skill-Building

• ClinicalTrials.gov Identifier: NCT03635151
• Recruitment Status: Completed
• First Posted: August 17, 2018
• Last Update Posted: October 27, 2021
• Sponsor: University of Cincinnati
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Tamilyn Bakas, University of Cincinnati

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Family Caregivers; Stroke	Behavioral: Telephone Assessment and Skill-Building Kit (TASK III) Group; Behavioral: Information Support and Referral (ISR) Group	Not Applicable

Detailed Description:

Stroke is a leading cause of serious, long-term disability, and has a very sudden onset; families are often thrust into providing care without any training from health care providers. Studies have shown that caregiving without training can be detrimental to caregiver's physical and mental health, which can impede survivor rehabilitation and lead to institutionalization and higher societal costs. Unlike existing stroke caregiver interventions that require costly face to face interactions, and that focus primarily on the survivor's care, the Telephone Assessment and Skill-Building Kit (TASK II) is delivered completely by telephone, and empowers caregivers to address both their own and the survivor's needs using innovative skill-building strategies. Aligned with current patient and caregiver guidelines, TASK II has demonstrated evidence of content validity, treatment fidelity, caregiver satisfaction, and efficacy for reducing depressive symptoms; however, future development of TASK II requires a stronger focus on self-management strategies to improve caregiver health, and enhanced use of other telehealth modes of delivery prior to implementation into ongoing stroke systems of care. The purpose of this study is to optimize the TASK III intervention through the innovative leveraging of technologies and theoretically-based self-management strategies to improve caregiver health. Specific Aim 1 consists of focus groups and individual interviews with 40 experts (10 interdisciplinary researchers, 10 technology experts, 10 clinicians and clinical leaders, and 10 stroke family caregivers) to provide preferences about essential areas of new self-management content, proposed technologies (e.g., iBook, eBook, interactive website, FaceTime, Zoom), and future implementation strategies to inform a novel TASK III prototype. Specific Aim 2 will determine feasibility of the TASK III intervention with a pilot study of 74 stroke caregivers randomized to TASK III or an Information, Support, and Referral (ISR) group in preparation for a larger randomized controlled clinical trial. Recruitment, retention, treatment fidelity, satisfaction, and technology ratings will be obtained for both TASK III and ISR groups who will receive 8 weekly sessions with a booster session 4 weeks later. Outcome measures will be explored at baseline, 8 weeks (end of intervention), and 12 weeks (after booster). If TASK III is shown to be efficacious in a future randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and, someday to adapt it for use among caregivers with other debilitating/chronic conditions providing a tremendous public health impact.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Caregiver Self-Management Needs Through Skill-Building
• Actual Study Start Date: April 9, 2018
• Actual Primary Completion Date: June 30, 2021
• Actual Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: TASK III Group; The Telephone Assessment and Skill-Building Kit (TASK III) group	Behavioral: Telephone Assessment and Skill-Building Kit (TASK III) Group; 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.
Active Comparator: ISR Group; The Information, Support, and Referral (ISR) group	Behavioral: Information Support and Referral (ISR) Group; 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.

Outcome Measures

Primary Outcome Measures :

1. Caregiver satisfaction ratings for both TASK III and ISR programs measured by the Caregiver Satisfaction Scale (CSS). [ Time Frame: 12 weeks ]
   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 with a possible range of 9 to 45. Higher scores indicate greater satisfaction.

Secondary Outcome Measures :

1. Depressive symptoms measured by the Patient Health Questionnaire Depression Scale (PHQ-9). [ Time Frame: Baseline to 8 and 12 weeks ]
   Caregiver depressive symptoms are measured by the Patient Health Questionnaire Depression Scale (PHQ-9) consisting of 9 items rated on a response scale ranging from 0 = Not at all to 3 = Nearly every day. Items are summed for a total score with a possible range of 0 to 27. Higher scores indicate higher depressive symptoms.
2. 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). [ Time Frame: Baseline to 8 and 12 weeks ]
   Caregiver life changes (i.e., changes in social functioning, subjective well-being, and physical health as a result of providing care) are measured by the Bakas Caregiving Outcomes Scale (BCOS). The BCOS consists of 15 items rated on a response scale ranging from -3 (changed for the worst) to +3 (Changed for the best). The items are recoded (-3 = 1) (-2 = 2) (-1 = 3) (0 = 4) (1 = 5) (2 = 6) (3 = 7) so that positive numbers can be obtained for analysis. The recoded responses to the 15 items are summed for a total score with a possible range of 15-105. Higher scores indicate more positive life changes as a result of providing care.
3. Unhealthy Days measured by the number of unhealthy days in the past 30 days. [ Time Frame: Baseline to 8 and 12 weeks ]
   Caregiver unhealthy days are measured using the Unhealthy Days (UD) measure consisting of two items: How many days during the past 30 days was your physical health not good?; How many days during the past 30 days was your mental health not good? These items range from 0 = no unhealthy days to 30 = 30 unhealthy days. The two items are summed for a total score, with a cap of 30 days. Higher scores indicate more unhealthy days in the past 30 days.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 21 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Ohio

University of Cincinnati College of Nursing

Cincinnati, Ohio, United States, 45219

Sponsors and Collaborators

University of Cincinnati

National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Tamilyn Bakas, PhD, RN; University of Cincinnati College of Nursing

More Information

Additional Information:

TASK III Study Website 

Publications of Results:

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.

Bakas 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.

• Responsible Party: Tamilyn Bakas, Professor and Jane E. Procter Endowed Chair, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT03635151
• Other Study ID Numbers: 2016-8508; 1R21NR016992-01A1 ( U.S. NIH Grant/Contract )
• First Posted: August 17, 2018
• Last Update Posted: October 27, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tamilyn Bakas, University of Cincinnati:

Clinical trial