CaregivingNCT00646074
Self- Care TALK Study - Promoting Alzheimer's Disease (AD) Spousal Caregiver Health
A study testing Self-Care Talk in people with Caregiving, run by University of Kansas.
Trial summary
Most individuals with Alzheimer's or dementia return home, where their care is supported by family and friends. Although family caring at home is usually rewarding, it is often challenging, too. The demands and responsibilities of caring for a loved one at home can be stressful. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Caregiving
- What is being tested?
- Self-Care Talk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Aug 2008
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- Married or married equivalent
- Living with and caring for a spouse/partner diagnosed with Alzheimer's or dementia within the last 2 years
- Can participate by telephone
- Speaks English
Who cannot join
None listed.
About this study
Official title: Self Care TALK to Promote AD Spousal Caregiver Health
Most individuals with Alzheimer's or dementia return home, where their care is supported by family and friends. Although family caring at home is usually rewarding, it is often challenging, too. The demands and responsibilities of caring for a loved one at home can be stressful. The actual activities of caregiving vary according to the needs of the individual, but can include helping with bathing, dressing, eating, and many other activities. Caregivers must learn care techniques and how to manage changes in roles and lifestyle. While adjusting to these changes, caregivers may be advised to 'take care' of themselves, but may not receive guidance or support for doing this. In this study, we are testing a self-care intervention for older, spouse caregivers of persons with Alzheimer's or dementia to see how helpful the intervention is in reducing distress and in helping caregivers adopt and maintain healthy lifestyle behaviors.
We have developed an intervention for caregivers that is called Self-Care TALK. The intervention includes creating a health-promoting, self-care education and support partnership between caregivers and nurses through the use of weekly telephone conversations. Each conversation focuses on a health-related topic, such as: healthy habits, building self-esteem, focusing on the positive, avoiding role overload, communicating, and building meaning. The conversations follow a basic format, but also are unique to each person. Participants complete questionnaires before and after the intervention, so that we can test the effect of participation in Self-Care TALK on caregiver health.
We know that education and support about self-care can be achieved through partnerships between family caregivers and health care professionals. Our goal is to build on this knowledge in testing whether participation in the Self-Care TALK intervention will result in less distress and better health and well-being for spouse caregivers, compared to caregivers who receive no additional care beyond usual education and support. In working toward this goal, we are using a partnership approach, in which nurses and caregivers discuss several health-related topics and mutually identify creative solutions for caregivers to incorporate self-care and health-promotion strategies into their daily routines. Promoting healthy outcomes for caregivers is essential to supporting their personal well-being, and to fostering their ability to continue home care for their loved one.
Read the detailed description
Informal caregiving, or providing non-paid assistance for a family member or friend who is unable to care for self, is challenging and stressful. Caregivers commonly experience negative psychological, emotional, physical, and social outcomes, including depression, strain and other disruptions in health and well-being. The overall aim of the study is to test the effectiveness of a health-promoting self-care education and support partnership between advanced practice nurses (APNs) and older spouse caregivers, in reducing perceived caregiving strain and in promoting health. The theory-based, multi-dimensional Self-Care TALK intervention is provided using a telephone-based approach to facilitate participation among carers, considering their concurrent responsibilities in the caregiving role.
A randomized, treatment/comparison, repeated-measures experimental design is used to test the effectiveness of the health-promoting treatment (Self-Care TALK) compared to usual care, for spouse caregivers age 60 and older. Subjects must be living with and caring for the person with dementia and the dementia diagnosis must have been within 2 years of enrollment.
Subjects complete questionnaires at baseline (Time 1) before randomization to the treatment or comparison group. Treatment group subjects receive written materials related to self-care and health promotion for use during the TALK sessions. Self-Care TALK is implemented through 6 weekly telephone sessions with advanced practice nurses. Sessions focus on several self-care topics, including: healthy habits, building self-esteem, focusing on the positive, avoiding role overload, communicating, and building meaning. Basic content is structured, but conversations are individualized with regard to each person's environment, abilities, and activities.
All subjects complete questionnaires again at 8 weeks (Time 2), and 24 weeks (Time 3) after baseline. Treatment group subjects are hypothesized to have lower caregiving strain, higher perceived health, well-being, and self-efficacy related to health, and less depressive symptomatology than comparison group subjects. Promoting healthy outcomes for caregivers of persons with dementia is essential to fostering ability for continued home-based care. Comparison group subjects receive written materials related to self-care and health promotion post Time 3.
- Conditions
- Caregiving
- Being tested
- Self-Care Talk
- Keywords
- Caregiver, Alzheimer's disease, Caregiving as experienced by older adults caring for a spouse with Alzheimer's disease or dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care TalkBehavioural
6 conversational sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Self-Care TALK Receives: Behavioral: Self-Care Talk |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36v2, PCS (perceived physical health), SF-36v2, MCS (perceived mental health)
Measured: 2 and 6 months post enrollment
Secondary outcomes (1)
M-CSI; modified (caregiver strain), SRAHP (self-efficacy for health), CES-D (depression)
Measured: 2 and 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionMar 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregivingStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Cynthia Teel, PhD, RN, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646074
- Sponsor's protocol ID
- 1R21NR009560
- Status last verified
- Mar 2012
- First submitted
- 25 Mar 2008
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Care TALK to Promote AD Spousal Caregiver Health
- ClinicalTrials.gov ID
- NCT00646074
- Acronym / sponsor ID
- 1R21NR009560
- Conditions
- Caregiving
- Keywords
- Caregiver, Alzheimer's disease, Caregiving as experienced by older adults caring for a spouse with Alzheimer's disease or dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Jul 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 Mar 2008 (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.
Most individuals with Alzheimer's or dementia return home, where their care is supported by family and friends. Although family caring at home is usually rewarding, it is often challenging, too. The demands and responsibilities of caring for a loved one at home can be stressful. The actual activities of caregiving vary according to the needs of the individual, but can include helping with bathing, dressing, eating, and many other activities. Caregivers must learn care techniques and how to manage changes in roles and lifestyle. While adjusting to these changes, caregivers may be advised to 'take care' of themselves, but may not receive guidance or support for doing this. In this study, we are testing a self-care intervention for older, spouse caregivers of persons with Alzheimer's or dementia to see how helpful the intervention is in reducing distress and in helping caregivers adopt and maintain healthy lifestyle behaviors.
We have developed an intervention for caregivers that is called Self-Care TALK. The intervention includes creating a health-promoting, self-care education and support partnership between caregivers and nurses through the use of weekly telephone conversations. Each conversation focuses on a health-related topic, such as: healthy habits, building self-esteem, focusing on the positive, avoiding role overload, communicating, and building meaning. The conversations follow a basic format, but also are unique to each person. Participants complete questionnaires before and after the intervention, so that we can test the effect of participation in Self-Care TALK on caregiver health.
We know that education and support about self-care can be achieved through partnerships between family caregivers and health care professionals. Our goal is to build on this knowledge in testing whether participation in the Self-Care TALK intervention will result in less distress and better health and well-being for spouse caregivers, compared to caregivers who receive no additional care beyond usual education and support. In working toward this goal, we are using a partnership approach, in which nurses and caregivers discuss several health-related topics and mutually identify creative solutions for caregivers to incorporate self-care and health-promotion strategies into their daily routines. Promoting healthy outcomes for caregivers is essential to supporting their personal well-being, and to fostering their ability to continue home care for their loved one.
Detailed description
Informal caregiving, or providing non-paid assistance for a family member or friend who is unable to care for self, is challenging and stressful. Caregivers commonly experience negative psychological, emotional, physical, and social outcomes, including depression, strain and other disruptions in health and well-being. The overall aim of the study is to test the effectiveness of a health-promoting self-care education and support partnership between advanced practice nurses (APNs) and older spouse caregivers, in reducing perceived caregiving strain and in promoting health. The theory-based, multi-dimensional Self-Care TALK intervention is provided using a telephone-based approach to facilitate participation among carers, considering their concurrent responsibilities in the caregiving role.
A randomized, treatment/comparison, repeated-measures experimental design is used to test the effectiveness of the health-promoting treatment (Self-Care TALK) compared to usual care, for spouse caregivers age 60 and older. Subjects must be living with and caring for the person with dementia and the dementia diagnosis must have been within 2 years of enrollment.
Subjects complete questionnaires at baseline (Time 1) before randomization to the treatment or comparison group. Treatment group subjects receive written materials related to self-care and health promotion for use during the TALK sessions. Self-Care TALK is implemented through 6 weekly telephone sessions with advanced practice nurses. Sessions focus on several self-care topics, including: healthy habits, building self-esteem, focusing on the positive, avoiding role overload, communicating, and building meaning. Basic content is structured, but conversations are individualized with regard to each person's environment, abilities, and activities.
All subjects complete questionnaires again at 8 weeks (Time 2), and 24 weeks (Time 3) after baseline. Treatment group subjects are hypothesized to have lower caregiving strain, higher perceived health, well-being, and self-efficacy related to health, and less depressive symptomatology than comparison group subjects. Promoting healthy outcomes for caregivers of persons with dementia is essential to fostering ability for continued home-based care. Comparison group subjects receive written materials related to self-care and health promotion post Time 3.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Self-Care TalkSelf-Care TALK |
| 2 | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 years or older
- Married or married equivalent
- Living with and caring for a spouse/partner diagnosed with Alzheimer's or dementia within the last 2 years
- Can participate by telephone
- Speaks English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-Care Talk6 conversational sessions | Behavioural | 1 |
Primary outcome
SF-36v2, PCS (perceived physical health), SF-36v2, MCS (perceived mental health)
Time frame: 2 and 6 months post enrollment
1 secondary outcome
M-CSI; modified (caregiver strain), SRAHP (self-efficacy for health), CES-D (depression)
Time frame: 2 and 6 months post enrollment
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 7 Mar 2012.
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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.
Cynthia Teel, PhD, RN principal investigator
University of Kansas
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Talk in people with Caregiving, run by University of Kansas.
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 0 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
SF-36v2, PCS (perceived physical health), SF-36v2, MCS (perceived mental health) (time frame: 2 and 6 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2012.