Providing Care for People With Memory ProblemsNCT02205671
Building Better Caregivers: Development and Evaluation
A study testing Building Better Caregivers Small-group Workshop in people with Providing Care for People With Memory Problems, run by Stanford University at 1 site in United States.
Trial summary
The program consists of a 6-week small-group workshop for caregivers of people with memory problems. The goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Providing Care for People With Memory Problems
- What is being tested?
- Building Better Caregivers Small-group Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family or friend caregiver of someone with cognitive impairment for at least 10 hours per week
- 18 years of age or older
- Able to attend a workshop 2.5 hours per week for 6 weeks
- Speaks English
Who cannot join
- Professional caregiver
- Under 18 years of age
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94304
About this study
The program consists of a 6-week small-group workshop for caregivers of people with memory problems.
The goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and self-efficacy
Read the detailed description
The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a 2-day cross-training before leading a BBC workshop).
Participants will learn self-management skills such as decision making, goal setting, action planning, stress management, dealing with difficult behaviors, working with the health care system, planning for the future,building an exercise program, communication skills, healthy eating, etc.
All participants will complete follow up questionnaires and 6 and 12 months. They will have the option of completing the questionnaire by mail or telephone interview.
Once a particular workshop site is identified by a partner organization, Stanford will provide packets of consents and questionnaires to the site coordinator(non-Stanford). The site coordinator will either schedule an extra hour for the first meeting of the 6-week series, or an orientation meeting held a week or so before the workshop begins. During this time, the coordinator will announce to the prospective subjects that this study is being conducted and that they are invited to participate, and will pass out a consent, questionnaire and consent copy to each prospective participant. The consent and questionnaire are self-administered.
This study is longitudinal, so no randomization will take place.
Stanford holds no meetings, but receives the data. The site coordinators hold the orientation meetings. The workshops are scheduled by the various organizations, and they determine when and how the orientation time is scheduled. It will vary from site to site.
- Being tested
- Building Better Caregivers Small-group Workshop
- Keywords
- caregiving, chronic illness, patient education, self management
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Better Caregivers Small-group WorkshopBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Building Better Caregivers Small-group Workshop Receives: Behavioral: Building Better Caregivers Small-group Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
visual numeric 0-10 scale
Measured: baseline-1 year
Pain
visual numeric 0-10 scale
Measured: baseline-1 year
stress
visual numeric 0-10 scale
Measured: baseline-1 year
problems sleeping
visual numeric 0-10 scale
Measured: baseline-1 year
depression (PHQ-8)
8 item 0-3 scale
Measured: baseline-1 year
self-efficacy for caregiving
9-item 1-10 scale
Measured: baseline-1 year
caregiver stress
13-item 3 point scale
Measured: baseline-1 year
caregiver burden
12-item 5 point scale
Measured: baseline-1 year
health care utilization (doctor, emergency department, hospital)
number of times/days in past 6 month visited doctor, emergency department, hospital
Measured: baseline-1 year
exercise
number of minutes of exercise in past week
Measured: baseline- 1 year
general health
single item scale of overall health
Measured: baseline-1 year
Secondary outcomes (2)
care partner health utilization
number of MD ER hospital visits for person being cared for in past 6 months
Measured: baseline- 1 year
carepartners general health
single item scale of overall health of person being cared for
Measured: baseline-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Providing Care for People With Memory ProblemsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate Lorig, DRPH, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205671
- Sponsor's protocol ID
- 29894
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Better Caregivers: Development and Evaluation
- ClinicalTrials.gov ID
- NCT02205671
- Acronym / sponsor ID
- 29894
- Keywords
- caregiving, chronic illness, patient education, self management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Jul 2014 (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 program consists of a 6-week small-group workshop for caregivers of people with memory problems.
The goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and self-efficacy
Detailed description
The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a 2-day cross-training before leading a BBC workshop).
Participants will learn self-management skills such as decision making, goal setting, action planning, stress management, dealing with difficult behaviors, working with the health care system, planning for the future,building an exercise program, communication skills, healthy eating, etc.
All participants will complete follow up questionnaires and 6 and 12 months. They will have the option of completing the questionnaire by mail or telephone interview.
Once a particular workshop site is identified by a partner organization, Stanford will provide packets of consents and questionnaires to the site coordinator(non-Stanford). The site coordinator will either schedule an extra hour for the first meeting of the 6-week series, or an orientation meeting held a week or so before the workshop begins. During this time, the coordinator will announce to the prospective subjects that this study is being conducted and that they are invited to participate, and will pass out a consent, questionnaire and consent copy to each prospective participant. The consent and questionnaire are self-administered.
This study is longitudinal, so no randomization will take place.
Stanford holds no meetings, but receives the data. The site coordinators hold the orientation meetings. The workshops are scheduled by the various organizations, and they determine when and how the orientation time is scheduled. It will vary from site to site.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Building Better Caregivers Small-group WorkshopBuilding Better Caregivers Small-group Workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Family or friend caregiver of someone with cognitive impairment for at least 10 hours per week
- 18 years of age or older
- Able to attend a workshop 2.5 hours per week for 6 weeks
- Speaks English
Key exclusion criteria (3 listed)
- Professional caregiver
- Under 18 years of age
- Non-English speaking
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 Small-group Workshop | Behavioural | Intervention |
Primary outcome
Fatigue
Time frame: baseline-1 year
visual numeric 0-10 scale
Pain
Time frame: baseline-1 year
visual numeric 0-10 scale
stress
Time frame: baseline-1 year
visual numeric 0-10 scale
problems sleeping
Time frame: baseline-1 year
visual numeric 0-10 scale
depression (PHQ-8)
Time frame: baseline-1 year
8 item 0-3 scale
self-efficacy for caregiving
Time frame: baseline-1 year
9-item 1-10 scale
caregiver stress
Time frame: baseline-1 year
13-item 3 point scale
caregiver burden
Time frame: baseline-1 year
12-item 5 point scale
health care utilization (doctor, emergency department, hospital)
Time frame: baseline-1 year
number of times/days in past 6 month visited doctor, emergency department, hospital
exercise
Time frame: baseline- 1 year
number of minutes of exercise in past week
general health
Time frame: baseline-1 year
single item scale of overall health
2 secondary outcomes
care partner health utilization
Time frame: baseline- 1 year
carepartners general health
Time frame: baseline-1 year
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 25 Apr 2017.
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 Lorig, DRPH principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Better Caregivers Small-group Workshop in people with Providing Care for People With Memory Problems, run by Stanford 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 4 inclusion and 3 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 25 Apr 2017. 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?
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?
Fatigue (time frame: baseline-1 year). The study lists 11 primary outcomes in all. 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 25 Apr 2017.