Family CaregiversNCT05304078
Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)
A study testing Telehealth Assessment and Skill-Building Kit (TASK III) Group and Information Support and Referral (ISR) Group in people with Family Caregivers and Stroke, run by University of Cincinnati at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Caregivers, Stroke
- What is being tested?
- Telehealth Assessment and Skill-Building Kit (TASK III) Group and Information Support and Referral (ISR) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati College of Nursing
Cincinnati, Ohio, 45219
About this study
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.
Read the 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.
- Conditions
- Family Caregivers, Stroke
- Being tested
- Telehealth Assessment and Skill-Building Kit (TASK III) Group, Information Support and Referral (ISR) Group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Assessment and Skill-Building Kit (TASK III) GroupBehavioural
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.
Information Support and Referral (ISR) GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TASK III Group | Experimental | The Telehealth Assessment and Skill-Building Kit (TASK III) group Receives: Behavioral: Telehealth Assessment and Skill-Building Kit (TASK III) Group |
| ISR Group | Active comparator | The Information, Support, and Referral (ISR) group Receives: Behavioral: Information Support and Referral (ISR) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Changes
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.
Measured: Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks
Secondary outcomes (7)
Depressive Symptoms
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.
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Other Symptoms
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.
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Unhealthy Days
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.
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Steps
Pedometer measuring number of steps per day.
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Exercise
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).
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Self-management of Diet
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.
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Healthcare Utilization
Self-reported past 3 months, hospitalizations, ER visits, Office visits (medical, dental, vision), immunizations, screening.
Measured: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start30 Nov 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Tamilyn Bakas, University of Cincinnati
- Investigators
- Tamilyn Bakas, PhD, RN, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304078
- Sponsor's protocol ID
- 2022-0180
- Other IDs
- R01NR020184
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Bakas T, Miller E, Sucharew H, Kreitzer N, Israel J, Rota M, Harnett B, Dunning K, Jones H, McCarthy M, Brehm B, Austin JK, Mitchell PH. Examining the Efficacy of the Telehealth Assessment and Skill-Building Kit (TASK III) Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2025 Mar 25;14:e67219. doi: 10.2196/67219.
PubMed 39937971
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)
- ClinicalTrials.gov ID
- NCT05304078
- Acronym / sponsor ID
- 2022-0180
- Conditions
- Family Caregivers, Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TASK III Group | Experimental | Behavioral: Telehealth Assessment and Skill-Building Kit (TASK III) GroupThe Telehealth Assessment and Skill-Building Kit (TASK III) group |
| ISR Group | Active comparator | Behavioral: Information Support and Referral (ISR) GroupThe Information, Support, and Referral (ISR) group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Had not had a stroke.
- Did not need help from the caregiver.
- Resides in a nursing home or long-term care facility.
- Under the age of 18 years.
- Prisoner or on house arrest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Assessment and Skill-Building Kit (TASK III) GroupThe 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. | Behavioural | TASK III Group |
| Information Support and Referral (ISR) GroupThe 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. | Behavioural | ISR Group |
Primary outcome
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.
7 secondary outcomes
Depressive Symptoms
Time frame: 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)
Unhealthy Days
Time frame: 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)
Self-management of Exercise
Time frame: 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)
Healthcare Utilization
Time frame: Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 39937971Bakas T, Miller E, Sucharew H, Kreitzer N, Israel J, Rota M, Harnett B, Dunning K, Jones H, McCarthy M, Brehm B, Austin JK, Mitchell PH. Examining the Efficacy of the Telehealth Assessment and Skill-Building Kit (TASK III) Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2025 Mar 25;14:e67219. doi: 10.2196/67219.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamilyn Bakas, PhD, RN principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Assessment and Skill-Building Kit (TASK III) Group and Information Support and Referral (ISR) Group in people with Family Caregivers and Stroke, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Changes (time frame: Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.