DementiaPhase 1NCT00799786
Building Better Caregivers Online: An Online Workshop for Caregivers of Those With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Alzheimer's or Other Dementia
A Phase 1 study testing Building Better Caregivers Online Workshop in people with Dementia and Brain Injuries, run by Stanford University at 2 sites in United States.
Trial summary
The workshop is a 6-week online workshop for caregivers of people with traumatic brain injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System and is supported by a grant from the Department of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Brain Injuries, Stress Disorders, Traumatic
- What is being tested?
- Building Better Caregivers Online Workshop
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Dec 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:Any adult (18 and over) who provides caregiving services for at least 10 hours per week (counting direct caregiving and related activities) for a veteran with traumatic brain injury, post traumatic stress disorder, or dementia, or is a veteran giving care to someone with one of these disorders, and has access to the internet and an email account. A caregiver is defined as any relative, partner, friend or neighbor who has a significant personal relationship with and provides a broad range of assistance for an older person or an adult with a chronic or disabling condition. These individuals may be the sole caregiver or one of several that live with or separately from the person receiving care.
- Live in California
- Have access to the internet and an email account
- Able to read English Exclusion Criteria:Live outside of California, Hawaii or Southern Nevada, under 18 years of age, not have access to a computer and own emai
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greater Los Angeles VA
Los Angeles, California
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Building Better Caregivers Online
The workshop is a 6-week online workshop for caregivers of people with traumatic brain injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System and is supported by a grant from the Department of Veterans Affairs, Patient Care Services, Office of Care Management and Social Work.
The goal of the study is to determine whether an online caregiver education and support workshop can have lasting beneficial effects in helping caregivers improve their self-management of health skills, stress, and improve their caregiving abilities.
Read the detailed description
The workshop is a 6-week online workshop for caregivers of people with traumatic brain injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System and is supported by a grant from the Department of Veterans Affairs, Patient Care Services, Office of Care Management and Social Work.
The goal of the study is to determine whether an online caregiver education and support workshop can have lasting beneficial effects in helping caregivers improve their self-management of health skills, stress, and improve their caregiving abilities.
This study is designed to enroll 120 participants living in California, Hawaii or Southern Nevada. Your participation in the workshop is expected to last six weeks, and the study will last 1 year.
This workshop is aimed at helping you to better manage your own health and the demands placed on you because of caregiving.
With the moderators and other workshop participants, you will discuss:
- Stress reduction
- Goal setting
- Maintaining your health
- Dealing with difficult emotions
- Handling difficult behaviors
- Better decision making
- Communicating better with health care professionals
- Communicating better with your friends, family and coworkers
If you participate in the workshop, you will take it online with 20-25 other people like you who are caregivers for veterans with TBI, PTSD, or dementia, or are veterans giving care to someone with these disorders. Each week you will log on to the study web site at least three times for a total time per week of about 2 hours. The first time you log on each week should be on the first or second day of the workshop, but you may log on at any time you find convenient. You may log on as often as you wish and at any time during the week. There is no time when all of you must log on at the same time.
Each week, you will be asked to read material on line, to complete activities on the web site, to make and share an action plan (for something you choose each week), to share your caregiving-related problems with others in your group, and most important of all, to help and support other group members with your experiences and wisdom. You will participate by using an anonymous screen name, and none of the other workshop members will know your real name.
Everyone in the study will be asked to fill out 4 brief online questionnaires about your health, medical care, activities and mood. You will fill out one questionnaire now, one two months after the beginning of the workshop, and another one in six months, and one in one year. Each questionnaire will take about 30 minutes to complete. Shortly after the workshop, we may ask you to participate in an email discussion group designed to get your feedback about the workshop. For the follow up questionnaires at 2, 6 and 12 months after you start the workshop you will receive a $10 Amazon.com certificate for each questionnaire to compensate you for your time and effort.
- Conditions
- Dementia, Brain Injuries, Stress Disorders, Traumatic
- Being tested
- Building Better Caregivers Online Workshop
- Medical subject headings
- Dementia, Brain Injuries, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Better Caregivers Online WorkshopBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
quality o flife, health status, and medical care utilization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Greater Los Angeles Healthcare System
- Investigators
- Kate R Lorig, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799786
- Sponsor's protocol ID
- SU-11212008-1350
- Other IDs
- 40137
- Status last verified
- Aug 2010
- First submitted
- 26 Nov 2008
- Last updated
- 13 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Better Caregivers Online
- ClinicalTrials.gov ID
- NCT00799786
- Acronym / sponsor ID
- SU-11212008-1350
- Conditions
- Dementia, Brain Injuries, Stress Disorders, Traumatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- VA Greater Los Angeles Healthcare System
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Dec 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.
The workshop is a 6-week online workshop for caregivers of people with traumatic brain injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System and is supported by a grant from the Department of Veterans Affairs, Patient Care Services, Office of Care Management and Social Work.
The goal of the study is to determine whether an online caregiver education and support workshop can have lasting beneficial effects in helping caregivers improve their self-management of health skills, stress, and improve their caregiving abilities.
Detailed description
The workshop is a 6-week online workshop for caregivers of people with traumatic brain injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System and is supported by a grant from the Department of Veterans Affairs, Patient Care Services, Office of Care Management and Social Work.
The goal of the study is to determine whether an online caregiver education and support workshop can have lasting beneficial effects in helping caregivers improve their self-management of health skills, stress, and improve their caregiving abilities.
This study is designed to enroll 120 participants living in California, Hawaii or Southern Nevada. Your participation in the workshop is expected to last six weeks, and the study will last 1 year.
This workshop is aimed at helping you to better manage your own health and the demands placed on you because of caregiving.
With the moderators and other workshop participants, you will discuss:
- Stress reduction
- Goal setting
- Maintaining your health
- Dealing with difficult emotions
- Handling difficult behaviors
- Better decision making
- Communicating better with health care professionals
- Communicating better with your friends, family and coworkers
If you participate in the workshop, you will take it online with 20-25 other people like you who are caregivers for veterans with TBI, PTSD, or dementia, or are veterans giving care to someone with these disorders. Each week you will log on to the study web site at least three times for a total time per week of about 2 hours. The first time you log on each week should be on the first or second day of the workshop, but you may log on at any time you find convenient. You may log on as often as you wish and at any time during the week. There is no time when all of you must log on at the same time.
Each week, you will be asked to read material on line, to complete activities on the web site, to make and share an action plan (for something you choose each week), to share your caregiving-related problems with others in your group, and most important of all, to help and support other group members with your experiences and wisdom. You will participate by using an anonymous screen name, and none of the other workshop members will know your real name.
Everyone in the study will be asked to fill out 4 brief online questionnaires about your health, medical care, activities and mood. You will fill out one questionnaire now, one two months after the beginning of the workshop, and another one in six months, and one in one year. Each questionnaire will take about 30 minutes to complete. Shortly after the workshop, we may ask you to participate in an email discussion group designed to get your feedback about the workshop. For the follow up questionnaires at 2, 6 and 12 months after you start the workshop you will receive a $10 Amazon.com certificate for each questionnaire to compensate you for your time and effort.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Building Better Caregivers Online Workshop | Behavioural | – |
Primary outcome
quality o flife, health status, and medical care utilization
Time frame: 6 months
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 13 Aug 2010.
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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.
Kate R Lorig principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Building Better Caregivers Online Workshop in people with Dementia and Brain Injuries, run by Stanford University at 2 sites 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?
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 13 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
quality o flife, health status, and medical care utilization (time frame: 6 months). 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 13 Aug 2010.