Family Caregivers of Stroke SurvivorsPhase 1NCT00264745
Telephone Assessment and Skill-Building Kit (TASK): A New Program for Family Caregivers of Stroke Survivors
A Phase 1 study testing TASK intervention in people with Family Caregivers of Stroke Survivors and Stroke, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to test a new educational program for families taking care of persons who have had a stroke. Caregivers are asked what they think of the TASK program and how to make it better. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Caregivers of Stroke Survivors, Stroke
- What is being tested?
- TASK intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Sep 2007
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A family caregiver must (1) be an unpaid family member or friend of a stroke patient who has not been home from the hospital or nursing home more than 2 months, (2) be the main person who takes care of the stroke patient at home, (3) be able to read and speak English, (4) be able to talk and hear using the telephone, and (5) be willing to have 8 weekly calls from a nurse and 4 calls from a research assistant.
Who cannot join
- We are unable to enroll caregivers or stroke survivors who (1) have a very serious illness and are expected to live no more than 6 months, (2) have severe mental illness, (3) have a history of alcohol or drug abuse, (4) are pregnant, (5) are prisoners or on house arrest, or (6) are living in a nursing home.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this study
Official title: Caregiver Telephone Assessment and Skill-Building Kit
The purpose of this study is to test a new educational program for families taking care of persons who have had a stroke. Caregivers are asked what they think of the TASK program and how to make it better. After getting the TASK program, their ability to provide care will be compared with a group that did not receive the TASK program.
Read the detailed description
Stroke is the number one cause of long-term disability in the United States. Many people who have had a stroke need help from family members after they go home. Taking care of a stroke patient can be hard since they can be unable to walk, talk, see, or think clearly. Behavior problems, changes in personality, and depression are also common. Providing care for a family member with stroke can often lead to caregiver depression, social isolation, and health problems. Not having caregiving skills may be one reason for these problems. Programs are needed to help caregivers learn caregiving skills. Such skills include finding information about stroke, dealing with the stroke patient's emotions and behaviors, providing personal and other types of care, and taking care of oneself as a caregiver.
The National Institute of Nursing Research said that learning how to help families cope with a relatives' chronic illness is a very important area for research. The TASK program is an attempt to meet this need. If the TASK program appears to be helpful and usable in this small beginning study, we will then try to test the program more completely in a much larger research study.
The informed consent explains the purpose and procedures for the study. The purpose is to test the TASK program in a small group of family caregivers of persons who have had a stroke. Caregivers are assigned to either the TASK group or a second group. The TASK group will get the TASK notebook, and the second group will get a brochure from the American Stroke Association. Both groups will get a telephone call every week for 8 weeks from a nurse, each lasting about 30 minutes. At the beginning and at 4, 8, and 12 weeks there will be a longer interview lasting about an hour. Caregivers get a $20 Wal-Mart gift card for each of the 4 interview calls. Calls are made at times that are convenient for the caregiver. All calls are tape-recorded. No names are used on the tape recordings or on any of the interview questionnaires. There is a very small risk that some parts of the study may remind some caregivers of their own situations and may be stressful or upsetting. Caregivers may choose not to answer questions or may leave the study at any time. Taking part in the study is up to them. Benefits include getting a $20 Wal-Mart gift card after each long interview (up to $80 in Wal-Mart gift cards for all 4 interviews). Caregivers also get free written information about stroke and caregiving, and free calls from a nurse. Telephone numbers are provided for questions about the study, rights as a research participant, and who to contact for emotional distress.
- Conditions
- Family Caregivers of Stroke Survivors, Stroke
- Being tested
- TASK intervention, Attention Control
- Keywords
- Caregiver, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASK interventionBehavioural
The Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers.
Attention ControlBehavioural
Minimal intervention beyond initial hospital visit.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: TASK intervention |
| 2 | Active comparator | Not described Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine how useful the TASK program is for family caregivers; and to compare how difficult the caregiving tasks are for the caregivers, whether they feel depressed, and how they see their own health.
Measured: baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJun 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Family Caregivers of Stroke SurvivorsStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Tamilyn Bakas, RN, DNS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264745
- Sponsor's protocol ID
- 1-35-6001673-A1
- Other IDs
- K01NR008712, 1K01NR008712-01
- Status last verified
- Oct 2008
- First submitted
- 9 Dec 2005
- Last updated
- 12 Jan 2011
- Results posted
- 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. 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 19941582Bakas 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 19581197Crocker 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 34813082
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Telephone Assessment and Skill-Building Kit
- ClinicalTrials.gov ID
- NCT00264745
- Acronym / sponsor ID
- 1-35-6001673-A1
- Conditions
- Family Caregivers of Stroke Survivors, Stroke
- Keywords
- Caregiver, Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jun 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Dec 2005 (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 a new educational program for families taking care of persons who have had a stroke. Caregivers are asked what they think of the TASK program and how to make it better. After getting the TASK program, their ability to provide care will be compared with a group that did not receive the TASK program.
Detailed description
Stroke is the number one cause of long-term disability in the United States. Many people who have had a stroke need help from family members after they go home. Taking care of a stroke patient can be hard since they can be unable to walk, talk, see, or think clearly. Behavior problems, changes in personality, and depression are also common. Providing care for a family member with stroke can often lead to caregiver depression, social isolation, and health problems. Not having caregiving skills may be one reason for these problems. Programs are needed to help caregivers learn caregiving skills. Such skills include finding information about stroke, dealing with the stroke patient's emotions and behaviors, providing personal and other types of care, and taking care of oneself as a caregiver.
The National Institute of Nursing Research said that learning how to help families cope with a relatives' chronic illness is a very important area for research. The TASK program is an attempt to meet this need. If the TASK program appears to be helpful and usable in this small beginning study, we will then try to test the program more completely in a much larger research study.
The informed consent explains the purpose and procedures for the study. The purpose is to test the TASK program in a small group of family caregivers of persons who have had a stroke. Caregivers are assigned to either the TASK group or a second group. The TASK group will get the TASK notebook, and the second group will get a brochure from the American Stroke Association. Both groups will get a telephone call every week for 8 weeks from a nurse, each lasting about 30 minutes. At the beginning and at 4, 8, and 12 weeks there will be a longer interview lasting about an hour. Caregivers get a $20 Wal-Mart gift card for each of the 4 interview calls. Calls are made at times that are convenient for the caregiver. All calls are tape-recorded. No names are used on the tape recordings or on any of the interview questionnaires. There is a very small risk that some parts of the study may remind some caregivers of their own situations and may be stressful or upsetting. Caregivers may choose not to answer questions or may leave the study at any time. Taking part in the study is up to them. Benefits include getting a $20 Wal-Mart gift card after each long interview (up to $80 in Wal-Mart gift cards for all 4 interviews). Caregivers also get free written information about stroke and caregiving, and free calls from a nurse. Telephone numbers are provided for questions about the study, rights as a research participant, and who to contact for emotional distress.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: TASK intervention |
| 2 | Active comparator | Behavioral: Attention Control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A family caregiver must (1) be an unpaid family member or friend of a stroke patient who has not been home from the hospital or nursing home more than 2 months, (2) be the main person who takes care of the stroke patient at home, (3) be able to read and speak English, (4) be able to talk and hear using the telephone, and (5) be willing to have 8 weekly calls from a nurse and 4 calls from a research assistant.
Key exclusion criteria (1 listed)
- We are unable to enroll caregivers or stroke survivors who (1) have a very serious illness and are expected to live no more than 6 months, (2) have severe mental illness, (3) have a history of alcohol or drug abuse, (4) are pregnant, (5) are prisoners or on house arrest, or (6) are living in a nursing home.
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 |
|---|---|---|
| TASK interventionThe Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers. | Behavioural | 1 |
| Attention ControlMinimal intervention beyond initial hospital visit. | Behavioural | 2 |
Primary outcome
To determine how useful the TASK program is for family caregivers; and to compare how difficult the caregiving tasks are for the caregivers, whether they feel depressed, and how they see their own health.
Time frame: baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 12 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 12 Jan 2011.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- 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.
Related trials for Family Caregivers of Stroke Survivors
Recruiting
ACT Group for Family Caregivers of Stroke Survivors
Caregiver Stress, Caregiver Stress Syndrome
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, RN, DNS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TASK intervention in people with Family Caregivers of Stroke Survivors and Stroke, 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 1 inclusion and 1 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 12 Jan 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine how useful the TASK program is for family caregivers; and to compare how difficult the caregiving tasks are for the caregivers, whether they feel depressed, and how they see their own health. (time frame: baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 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 NCT00264745, which also lists 4 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 12 Jan 2011.