StrokePhase 3TASKIINCT01275495
Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
A Phase 3 study testing Telephone Assessment and Skill-Building Kit (TASK II) and Information, Support, and Referral (ISR) in people with Stroke and Family Caregivers, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Family Caregivers
- What is being tested?
- Telephone Assessment and Skill-Building Kit (TASK II) and Information, Support, and Referral (ISR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Primary caregiver (unpaid family member or significant other) of a stroke survivor
- No more than 8 weeks after survivor discharged home
- Plans to be providing care for 1 year or longer
- Access to a telephone
- Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points
Who cannot join
- Caregiver or survivor age < 21 years
- Caregiver denies that survivor has had a stroke
- Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke
- Caregiver has low task difficulty (OCBS task difficulty score < 16)
- Caregiver communication difficulties (e.g., hearing loss)
- Caregiver not fluent in the English language
Show all 13Show fewer
- Caregiver 6-item MMSE score less than 4
- Survivor residing in a nursing home or long-term care facility
- Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis)
- Survivor or caregiver history of hospitalization for alcohol or drug abuse
- Survivor or caregiver history of severe mental illness (e.g., Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, schizophrenia)
- Survivor or caregiver pregnancy
- Survivor or caregiver is a prisoner or on house arrest
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.
Read the detailed description
Stroke is the number one cause of disability in the United States, and over 4 million stroke survivors are alive today. Many stroke survivors need the help of a family caregiver. A family caregiver is a family member or close friend who helps the stroke survivor once they go home. Many caregivers need information and support during the first few months after the stroke survivor is discharged home. One group of caregivers will receive the TASK II intervention and another group of caregivers will receive existing educational materials about stroke and caregiving through an information, support, and referral (ISR) process. Both groups of caregivers will receive written materials about stroke and caregiving by mail and weekly telephone calls by a nurse for a total of 8 weeks, with an additional call at 12 weeks. A research assistant will also call by telephone at the beginning of the study, and at 8, 12, and 24 weeks after the beginning of the study, with a follow-up call at 1 year to interview both groups of caregivers about their caregiving activities and about their own health and well-being. If shown to be efficacious, our next goal will be to translate the TASK II intervention into practice settings to meet current recommendations and guidelines that emphasize follow up care for stroke survivors and their family caregivers.
- Conditions
- Stroke, Family Caregivers
- Being tested
- Telephone Assessment and Skill-Building Kit (TASK II), Information, Support, and Referral (ISR)
- Keywords
- Stroke, Family Caregivers, Cerebrovascular Accident, Carers, Care Givers, Depression, Life change events, Family health, Quality of life, Cost, Intervention studies, Clinical trial
- Medical subject headings
- Stroke, Depression
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 II)Behavioural
Information, Support, and Referral (ISR)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Telephone Assessment and Skill-Building Kit (TASK II) | Experimental | The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns. Receives: Behavioral: Telephone Assessment and Skill-Building Kit (TASK II) |
| Information, Support, and Referral (ISR) | Active comparator | The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks. Receives: Behavioral: Information, Support, and Referral (ISR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Measured: Change in depressive symptoms from baseline to 8 weeks
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Caregivers randomized to the TASK II group will have a greater reduction in caregiving-related negative life changes compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Measured: Change in caregiving-related negative life changes from baseline to 8 weeks
Unhealthy days: Unhealthy Days (UD)
Caregivers randomized to the TASK II group will have a greater reduction in unhealthy days compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Measured: Change in unhealthy days from baseline to 8 weeks
Secondary outcomes (3)
Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)
Caregivers randomized to the TASK II group will have a greater reduction in task difficulty compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Measured: Change in task difficulty from baseline to 8 weeks
Optimism: Revised Life Orientation Test (LOT-R)
Caregivers randomized to the TASK II group will have a greater increase in optimism compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Measured: Change in optimism from baseline to 8 weeks
Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)
Caregivers randomized to the TASK II group will have a greater reduction in threat appraisal compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Measured: Change in threat appraisal from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275495
- Sponsor's protocol ID
- 1003-63
- Other IDs
- R01NR010388
- Acronym
- TASKII
- Status last verified
- Mar 2015
- First submitted
- 10 Jan 2011
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakas T, Li Y, Habermann B, McLennon SM, Weaver MT. Developing a cost template for a nurse-led stroke caregiver intervention program. Clin Nurse Spec. 2011 Jan-Feb;25(1):41-6. doi: 10.1097/NUR.0b013e318203cb92.
PubMed 21139466Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Top Stroke Rehabil. 2009 Mar-Apr;16(2):105-21. doi: 10.1310/tsr1602-105.
PubMed 19581197Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Content validity and satisfaction with a stroke caregiver intervention program. J Nurs Scholarsh. 2009;41(4):368-75. doi: 10.1111/j.1547-5069.2009.01282.x.
PubMed 19941582Kum C, Jones HJ, Miller EL, Kreitzer N, Bakas T. Theoretically Based Factors Associated With Stroke Family Caregiver Health. Rehabil Nurs. 2024 May-Jun 01;49(3):86-94. doi: 10.1097/RNJ.0000000000000458.
PubMed 38696434Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Bakas T, Austin JK, Habermann B, Jessup NM, McLennon SM, Mitchell PH, Morrison G, Yang Z, Stump TE, Weaver MT. Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial. Stroke. 2015 Dec;46(12):3478-87. doi: 10.1161/STROKEAHA.115.011099. Epub 2015 Nov 8.
PubMed 26549488McLennon SM, Hancock RD, Redelman K, Scarton LJ, Riley E, Sweeney B, Habermann B, Jessup NM, Bakas T. Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers. Clin Rehabil. 2016 May;30(5):495-507. doi: 10.1177/0269215515585134. Epub 2015 May 7.
PubMed 25952589Jessup NM, Bakas T, McLennon SM, Weaver MT. Are there gender, racial or relationship differences in caregiver task difficulty, depressive symptoms and life changes among stroke family caregivers? Brain Inj. 2015;29(1):17-24. doi: 10.3109/02699052.2014.947631. Epub 2014 Aug 20.
PubMed 25141098McLennon SM, Bakas T, Jessup NM, Habermann B, Weaver MT. Task difficulty and life changes among stroke family caregivers: relationship to depressive symptoms. Arch Phys Med Rehabil. 2014 Dec;95(12):2484-90. doi: 10.1016/j.apmr.2014.04.028. Epub 2014 May 22.
PubMed 24858447
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
- ClinicalTrials.gov ID
- NCT01275495
- Acronym / sponsor ID
- TASKII / 1003-63
- Conditions
- Stroke, Family Caregivers
- Keywords
- Stroke, Family Caregivers, Cerebrovascular Accident, Carers, Care Givers, Depression, Life change events, Family health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- May 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Jan 2011 (estimated)
- 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.
The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.
Detailed description
Stroke is the number one cause of disability in the United States, and over 4 million stroke survivors are alive today. Many stroke survivors need the help of a family caregiver. A family caregiver is a family member or close friend who helps the stroke survivor once they go home. Many caregivers need information and support during the first few months after the stroke survivor is discharged home. One group of caregivers will receive the TASK II intervention and another group of caregivers will receive existing educational materials about stroke and caregiving through an information, support, and referral (ISR) process. Both groups of caregivers will receive written materials about stroke and caregiving by mail and weekly telephone calls by a nurse for a total of 8 weeks, with an additional call at 12 weeks. A research assistant will also call by telephone at the beginning of the study, and at 8, 12, and 24 weeks after the beginning of the study, with a follow-up call at 1 year to interview both groups of caregivers about their caregiving activities and about their own health and well-being. If shown to be efficacious, our next goal will be to translate the TASK II intervention into practice settings to meet current recommendations and guidelines that emphasize follow up care for stroke survivors and their family caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Assessment and Skill-Building Kit (TASK II) | Experimental | Behavioral: Telephone Assessment and Skill-Building Kit (TASK II)The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns. |
| Information, Support, and Referral (ISR) | Active comparator | Behavioral: Information, Support, and Referral (ISR)The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary caregiver (unpaid family member or significant other) of a stroke survivor
- No more than 8 weeks after survivor discharged home
- Plans to be providing care for 1 year or longer
- Access to a telephone
- Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points
Key exclusion criteria (13 listed)
- Caregiver or survivor age < 21 years
- Caregiver denies that survivor has had a stroke
- Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke
- Caregiver has low task difficulty (OCBS task difficulty score < 16)
- Caregiver communication difficulties (e.g., hearing loss)
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 II) | Behavioural | Telephone Assessment and Skill-Building Kit (TASK II) |
| Information, Support, and Referral (ISR) | Behavioural | Information, Support, and Referral (ISR) |
Primary outcome
Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: Change in depressive symptoms from baseline to 8 weeks
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS)
Time frame: Change in caregiving-related negative life changes from baseline to 8 weeks
Caregivers randomized to the TASK II group will have a greater reduction in caregiving-related negative life changes compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Unhealthy days: Unhealthy Days (UD)
Time frame: Change in unhealthy days from baseline to 8 weeks
Caregivers randomized to the TASK II group will have a greater reduction in unhealthy days compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
3 secondary outcomes
Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS)
Time frame: Change in task difficulty from baseline to 8 weeks
Optimism: Revised Life Orientation Test (LOT-R)
Time frame: Change in optimism from baseline to 8 weeks
Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS)
Time frame: Change in threat appraisal from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Background: PubMed 21139466Bakas T, Li Y, Habermann B, McLennon SM, Weaver MT. Developing a cost template for a nurse-led stroke caregiver intervention program. Clin Nurse Spec. 2011 Jan-Feb;25(1):41-6. doi: 10.1097/NUR.0b013e318203cb92.
- Background: PubMed 19581197Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Top Stroke Rehabil. 2009 Mar-Apr;16(2):105-21. doi: 10.1310/tsr1602-105.
- Background: PubMed 19941582Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Content validity and satisfaction with a stroke caregiver intervention program. J Nurs Scholarsh. 2009;41(4):368-75. doi: 10.1111/j.1547-5069.2009.01282.x.
- Derived from this study: PubMed 38696434Kum C, Jones HJ, Miller EL, Kreitzer N, Bakas T. Theoretically Based Factors Associated With Stroke Family Caregiver Health. Rehabil Nurs. 2024 May-Jun 01;49(3):86-94. doi: 10.1097/RNJ.0000000000000458.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 26549488Bakas T, Austin JK, Habermann B, Jessup NM, McLennon SM, Mitchell PH, Morrison G, Yang Z, Stump TE, Weaver MT. Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial. Stroke. 2015 Dec;46(12):3478-87. doi: 10.1161/STROKEAHA.115.011099. Epub 2015 Nov 8.
- Derived from this study: PubMed 25952589McLennon SM, Hancock RD, Redelman K, Scarton LJ, Riley E, Sweeney B, Habermann B, Jessup NM, Bakas T. Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers. Clin Rehabil. 2016 May;30(5):495-507. doi: 10.1177/0269215515585134. Epub 2015 May 7.
- Derived from this study: PubMed 25141098Jessup NM, Bakas T, McLennon SM, Weaver MT. Are there gender, racial or relationship differences in caregiver task difficulty, depressive symptoms and life changes among stroke family caregivers? Brain Inj. 2015;29(1):17-24. doi: 10.3109/02699052.2014.947631. Epub 2014 Aug 20.
- Derived from this study: PubMed 24858447McLennon SM, Bakas T, Jessup NM, Habermann B, Weaver MT. Task difficulty and life changes among stroke family caregivers: relationship to depressive symptoms. Arch Phys Med Rehabil. 2014 Dec;95(12):2484-90. doi: 10.1016/j.apmr.2014.04.028. Epub 2014 May 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone Assessment and Skill-Building Kit (TASK II) and Information, Support, and Referral (ISR) in people with Stroke and Family Caregivers, run by Indiana University 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 5 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 31 Mar 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) (time frame: Change in depressive symptoms from baseline to 8 weeks). The study lists 3 primary outcomes in all. 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 NCT01275495, which also lists 9 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 31 Mar 2015.