Family CaregiversNCT03635151
Caregiver Self-Management Needs Through Skill-Building
A study testing Telephone 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 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Caregivers, Stroke
- What is being tested?
- Telephone 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
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
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 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.
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 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.
- Conditions
- Family Caregivers, Stroke
- Being tested
- Telephone Assessment and Skill-Building Kit (TASK III) Group, Information Support and Referral (ISR) Group
- Keywords
- Clinical trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Assessment and Skill-Building Kit (TASK III) GroupBehavioural
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.
Information Support and Referral (ISR) GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TASK III Group | Experimental | The Telephone Assessment and Skill-Building Kit (TASK III) group Receives: Behavioral: Telephone 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.
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.
Measured: 12 weeks
Secondary outcomes (3)
Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9).
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start9 Apr 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- 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
- 74 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 College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635151
- Sponsor's protocol ID
- 2016-8508
- Other IDs
- 1R21NR016992-01A1
- Status last verified
- Mar 2024
- First submitted
- 24 Jul 2018
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33075163Bakas 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.
PubMed 33512120
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Self-Management Needs Through Skill-Building
- ClinicalTrials.gov ID
- NCT03635151
- Acronym / sponsor ID
- 2016-8508
- Conditions
- Family Caregivers, Stroke
- Keywords
- Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 18 Apr 2024
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 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.
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
- 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: Telephone Assessment and Skill-Building Kit (TASK III) GroupThe Telephone 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
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- Scores <16 on the Oberst Caregiving Burden Scale Task Difficulty Subscale (for Specific Aim 2)
- Scores < 4 on a 6-item cognitive impairment screener.
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 |
|---|---|---|
| Telephone Assessment and Skill-Building Kit (TASK III) GroupThe 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. | Behavioural | TASK III Group |
| Information Support and Referral (ISR) GroupThe 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. | Behavioural | ISR Group |
Primary outcome
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, then divided by 9 (number of items) with a possible range of 1 to 5. Higher scores indicate greater satisfaction.
3 secondary outcomes
Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9).
Time frame: 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).
Time frame: 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.
Time frame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33075163Bakas 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.
- Results publication: PubMed 33512120Bakas 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.
- TASK III Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 18 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Caregiver Satisfaction Ratings for Both TASK III and ISR Programs Measured by the Caregiver Satisfaction Scale (CSS). (time frame: 12 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 NCT03635151, which also lists 2 linked publications.
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 18 Apr 2024.