DementiaNCT07006116
Caregiver Bootcamp
A study testing Synchronous/asynchronous online course in people with Dementia, run by Emory University at 1 site in United States.
Trial summary
This study will assess the preliminary efficacy of a synchronous/asynchronous psychoeducation program designed to promote caregiving mastery in the immediate time period after a dementia diagnosis. It will also study the effects on caregiver and care recipient well-being. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Synchronous/asynchronous online course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over the age of 21;
- care partner/caregiver for a family or friend who has received a diagnosis of a form dementia from a healthcare provider in the last 6 months;
- has access to an electronic device and/or access to broadband internet; and
- able to speak and understand English. Caregivers are not required to be co-located with the care recipient.
Who cannot join
- considering moving the PLWD to an institutional setting within the next 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nell Hodgson Woodruff School of Nursing
Atlanta, Georgia, 30322
About this study
Official title: Caregiver Bootcamp: Mastering the First Hundred Days
This study will assess the preliminary efficacy of a synchronous/asynchronous psychoeducation program designed to promote caregiving mastery in the immediate time period after a dementia diagnosis. It will also study the effects on caregiver and care recipient well-being.
Read the detailed description
The Caregiver Bootcamp program will employ psychoeducational methods (expert instruction, expectation of active learning by participants, debriefing and coaching linked to participant reports of application of strategies and principles) to enhance the proposed mechanism of action of the intervention, the enhancement of caregiving mastery - the individual's self-acknowledgement of self-efficacy for coping with the stresses of the new caregiving role.
The program is meant to provide basic orientation to the situation: recognize the reality of the condition; understand the shifts in mindset that the immediate situation demands; begin to recognize the shift in responsibility that will have to occur; and take practical steps to prepare for the future. The program will combine 5 weekly small group 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions.
- Conditions
- Dementia
- Being tested
- Synchronous/asynchronous online course
- Keywords
- Caregiver, Dementia, Person living with dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous/asynchronous online courseOther
- Synchronous weekly 90-120-minute-long sessions that will be conducted on a videoconferencing platform (i.e., Zoom). If participants miss a synchronous session.
- Asynchronous online course: available segments of the online course with asynchronous instructional materials delivered 2-4 days in between sessions, and supplemental course materials that will be received by mail.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous/asynchronous online course Participants | Experimental | The program will combine 5 weekly small group (8 participants) 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions.
A time suited to all for the synchronous sessions will be identified. The research team will provide instructions for accessing the weekly sessions and asynchronous segments, and mail out supplemental course materials. The team will track online attendance, and the Canvas platform will enable them to monitor each individual's viewing of the asynchronous materials. Receives: Other: Synchronous/asynchronous online course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver sense of mastery
The seven-item personal mastery scale developed by Pearlin and Schooler is used to measure mastery. All items are rated on a four-point scale: 1 = strongly agree; 2 = agree; 3 = disagree; to 4 = strongly disagree. Total scores ranged from 7 to 28, with higher scores indicating higher levels of mastery.
Measured: Baseline, 1 and 3-months post-intervention
Change in caregiver self-efficacy: symptom management scale
This outcome will be assessed with Likert scale questions. Includes 6 questions, each scored on a 0-10 scale. Total possible score range is 0-60, with higher score correlating with better study outcome.
Measured: Baseline, 1 and 3-months post-intervention
Change in caregiver self-efficacy: support services scale
This outcome will be assessed with Likert scale questions. Includes 4 questions, each scored on a 0-10 scale. Total possible score range is 0-40, with higher score correlating with better study outcome.
Measured: Baseline, 1 and 3-months post-intervention
Change in caregiver self-efficacy: medication management scale
This outcome will be assessed with Likert scale questions. Includes 5 questions, each scored on a 0-10 scale. Total possible score range is 0-50, with higher score correlating with better study outcome.
Measured: Baseline, 1 and 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start20 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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 Emory 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will enroll caregivers in six cohorts of 8 each to participate in this Stage Ib clinical trial.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Carolyn Clevenger, Emory University
- Investigators
- Carolyn Clevenger, RN, DNP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006116
- Sponsor's protocol ID
- STUDY00007427
- Other IDs
- 2P30AG064200-06
- Status last verified
- Aug 2026
- First submitted
- 28 May 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with controlled access for general research use as allowed by participants' informed consent and contingent on a requesting institution's Institutional Review Board approval and investigators' approved data sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Bootcamp: Mastering the First Hundred Days
- ClinicalTrials.gov ID
- NCT07006116
- Acronym / sponsor ID
- STUDY00007427
- Conditions
- Dementia
- Keywords
- Caregiver, Dementia, Person living with dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- 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.
This study will assess the preliminary efficacy of a synchronous/asynchronous psychoeducation program designed to promote caregiving mastery in the immediate time period after a dementia diagnosis. It will also study the effects on caregiver and care recipient well-being.
Detailed description
The Caregiver Bootcamp program will employ psychoeducational methods (expert instruction, expectation of active learning by participants, debriefing and coaching linked to participant reports of application of strategies and principles) to enhance the proposed mechanism of action of the intervention, the enhancement of caregiving mastery - the individual's self-acknowledgement of self-efficacy for coping with the stresses of the new caregiving role.
The program is meant to provide basic orientation to the situation: recognize the reality of the condition; understand the shifts in mindset that the immediate situation demands; begin to recognize the shift in responsibility that will have to occur; and take practical steps to prepare for the future. The program will combine 5 weekly small group 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will enroll caregivers in six cohorts of 8 each to participate in this Stage Ib clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Synchronous/asynchronous online course Participants | Experimental | Other: Synchronous/asynchronous online courseThe program will combine 5 weekly small group (8 participants) 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions. A time suited to all for the synchronous sessions will be identified. The research team will provide instructions for accessing the weekly sessions and asynchronous segments, and mail out supplemental course materials. The team will track online attendance, and the Canvas platform will enable them to monitor each individual's viewing of the asynchronous materials. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over the age of 21;
- care partner/caregiver for a family or friend who has received a diagnosis of a form dementia from a healthcare provider in the last 6 months;
- has access to an electronic device and/or access to broadband internet; and
- able to speak and understand English. Caregivers are not required to be co-located with the care recipient.
Key exclusion criteria (1 listed)
- considering moving the PLWD to an institutional setting within the next 6 months.
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 |
|---|---|---|
| Synchronous/asynchronous online course* Synchronous weekly 90-120-minute-long sessions that will be conducted on a videoconferencing platform (i.e., Zoom). If participants miss a synchronous session. * Asynchronous online course: available segments of the online course with asynchronous instructional materials delivered 2-4 days in between sessions, and supplemental course materials that will be received by mail. | Other | Synchronous/asynchronous online course Participants |
Primary outcome
Change in caregiver sense of mastery
Time frame: Baseline, 1 and 3-months post-intervention
The seven-item personal mastery scale developed by Pearlin and Schooler is used to measure mastery. All items are rated on a four-point scale: 1 = strongly agree; 2 = agree; 3 = disagree; to 4 = strongly disagree. Total scores ranged from 7 to 28, with higher scores indicating higher levels of mastery.
Change in caregiver self-efficacy: symptom management scale
Time frame: Baseline, 1 and 3-months post-intervention
This outcome will be assessed with Likert scale questions. Includes 6 questions, each scored on a 0-10 scale. Total possible score range is 0-60, with higher score correlating with better study outcome.
Change in caregiver self-efficacy: support services scale
Time frame: Baseline, 1 and 3-months post-intervention
This outcome will be assessed with Likert scale questions. Includes 4 questions, each scored on a 0-10 scale. Total possible score range is 0-40, with higher score correlating with better study outcome.
Change in caregiver self-efficacy: medication management scale
Time frame: Baseline, 1 and 3-months post-intervention
This outcome will be assessed with Likert scale questions. Includes 5 questions, each scored on a 0-10 scale. Total possible score range is 0-50, with higher score correlating with better study outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with controlled access for general research use as allowed by participants' informed consent and contingent on a requesting institution's Institutional Review Board approval and investigators' approved data sharing plan
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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.
Carolyn Clevenger, RN, DNP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous/asynchronous online course in people with Dementia, run by Emory 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 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in caregiver sense of mastery (time frame: Baseline, 1 and 3-months post-intervention). The study lists 4 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 19 Aug 2026.