Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)

February 23, 2026 updated by: Tamilyn Bakas, University of Cincinnati
Caring for a family member after a stroke can be very difficult and worsen the physical and mental health of untrained caregivers. The 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 their own health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 sufficient training from health care providers, having to learn on their own to provide care. Studies show that caregiving without proper 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, which require costly face-to-face interactions, and that focus primarily on the survivor's care, the nurse-led 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 demonstrated evidence of content validity, treatment fidelity, caregiver satisfaction, and efficacy for reducing caregiver depressive symptoms; however, TASK II revealed a need for a stronger focus on self-management (SM) strategies to improve caregiver symptoms and health, along with enhanced use of other telehealth modes of delivery. In an NINR-funded R21, the Telehealth Assessment and Skill-building Kit (TASK III) was optimized through the innovative leveraging of technologies and SM strategies to improve stroke family caregiver symptoms and health. A new goal setting tip sheet promotes caregivers' self-management of their own symptoms and health through the use of novel skill-building strategies. caregivers now choose how they want to access the TASK III Resource Guide (mailed hard copy, eBook, USB drive, or interactive website (https://www.task3web.com/) and how they would like to interact with the nurse (telephone, FaceTime, or online videoconferencing). Preliminary TASK III data provided evidence for feasibility of recruitment, retention, treatment fidelity, high satisfaction, and positive data trends in 74 stroke family caregivers randomized to TASK III (n=36) or to an Information, Support, and Referral (ISR) group (n=38). The purpose of the proposed study is to test short-term (immediately post-intervention at 8 weeks) and long-term (12, 24, and 52 weeks) efficacy of the TASK III intervention, compared with the ISR group, in 296 stroke caregivers. The primary outcome is caregiver life changes (i.e., physical health, physical functioning, emotional well-being, general health) as a result of providing care. Secondary outcomes include depressive symptoms (in caregivers with mild to severe depressive symptoms), other symptoms (stress, fatigue, sleep, pain, shortness of breath), unhealthy days, SM of diet/exercise, and self-reported healthcare utilization. Theoretically-based mediators include task difficulty, threat appraisal, and self-efficacy. Program evaluation outcomes (satisfaction, technology ratings) will also be analyzed. If TASK III is shown to be efficacious in the proposed randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and to adapt it for use among caregivers with other debilitating/chronic conditions providing a tremendous public health impact.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
332

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primary caregiver (family member or significant other providing care for a stroke survivor at home).
  • Fluent in the English language (i.e., able to read, speak, and understand English)
  • Access to telephone or computer.
  • No difficulties hearing or talking by telephone or computer.
  • Score 4 or more on a 6-item cognitive impairment screener.
  • Willing to participate in 9 calls from a nurse and 5 data collection interviews (Baseline, 8, 12, 24, 52).

Exclusion Criteria:

Excluded if the survivor:

  • Had not had a stroke.
  • Did not need help from the caregiver.
  • Resides in a nursing home or long-term care facility.

Excluded if the caregiver or survivor is:

  • Under the age of 18 years.
  • 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 within the past 5 years).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TASK III Group
The Telehealth Assessment and Skill-Building Kit (TASK III) group
Behavioral: Telehealth Assessment and Skill-Building Kit (TASK III) Group
The TASK III group will receive a TASK III Resource Guide (mailed hard copy, USB drive, eBook, and Website access) and 8 weekly calls from a nurse, with a booster call a month later (telephone, videoconferencing, or FaceTime). The TASK III nurse will train caregivers how to assess their needs and concerns, and how to use the TASK III Resource Guide containing content and skill-building tip sheets to address their needs and concerns. Caregivers will also receive an American Heart Association brochure about family caregiving, as well as information, support, and referral 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 about family caregiving and 8 weekly calls from a nurse, with a booster call a month later (telephone, videoconferencing, or FaceTime). The ISR nurse will provide information, support, and referral to community resources.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Life Changes
Time Frame: Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks
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). 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.
Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unhealthy Days
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Unhealthy Days (UD), 2 items, number of days in the past 30 days that physical and mental health have not been good. Items totaled, then capped at 30 days for a total score. Analyzed at the item level as well.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Steps
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Pedometer measuring number of steps per day.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Exercise
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Physical Activity Scale for Elderly, PASE; consists 10 items measuring physical activity. The total PASE score is computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by the empirically derived item weights and summing over all activities. The PASE score can be stratified in tertiles: 0 to 40 (sedentary), 41 to 90 (light physical activity) and more than 90 (moderate to intense activity).
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Diet
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Dietary Screener Questionnaire consists of 30 items measuring diet intake. Scores provide predicted intake of fruits, vegetables, added sugars, whole grains, fiber, calcium, and dairy.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Healthcare Utilization
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-reported past 3 months, hospitalizations, ER visits, Office visits (medical, dental, vision), immunizations, screening.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Depressive Symptoms
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Patient Health Questionnaire Depression Scale (PHQ-9) 9 items rated on a scale from 0 = not at all to 3 = nearly every day. Higher scores reflect more depressive symptoms.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Other Symptoms
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Visual numeric symptoms used in the Chronic Disease Self Management Program (CDSMP) study on a scale from 0-10 (stress, fatigue, sleep, pain, shortness of breath). Higher scores indicate higher severity of the symptom.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mediator: Threat Appraisal
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Appraisal of Caregiving Threat Subscale (ACS) consists of 12 items rated on a scale from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate higher threat appraisal.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Program Evaluation Outcomes: Satisfaction
Time Frame: 12 weeks
Caregiver Satisfaction Scale (CSS) usefulness, ease of use, and acceptability of the TASK III and ISR interventions consisting of 9 items rated on a scale from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate more positive program outcomes.
12 weeks
Mediator: Task Difficulty
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Oberst Caregiving Burden Scale Difficulty Subscale (OCBS) - 15 caregiving tasks rated based on level of difficulty. The OCBS consists of 15 items rated on a response scale ranging from -3 (extremely difficult) to +3 (extremely easy). 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. Lower scores indicate more difficulty with caregiving tasks.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Mediator: Self-efficacy of Exercise
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
The Self-Efficacy Exercise scale (SEE) consists of 10 items rated on a scale from 0 = not at all confident to 10 = extremely confident. Higher scores indicate greater self-efficacy of exercise.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Mediator: Self-efficacy of Diet
Time Frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
The Self-Efficacy Diet scale (SED) consists of 10 items rated on a scale from 0 = not at all confident to 10 = extremely confident. Higher scores indicate greater self-efficacy of diet.
Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Program Evaluation Outcomes: Technology
Time Frame: 12 weeks
Caregiver Technology Evaluation Scale (CETS) consisting of 8 items rated on a scale from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate more positive program outcomes.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tamilyn Bakas, PhD, RN, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0180
  • R01NR020184 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified investigators may request access to de-identified data from the University of Cincinnati. Special measures will be taken to ensure that caregivers or stroke survivors are not identifiable by any data that are shared. Close collaboration with Dr. Bakas and her research team will be necessary for the use of shared data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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