DementiaNCT06177990
Caregiver as Navigator: Develop Skills Online (CAN-DO)
A study testing Caregiver as Navigator: Develop Skills Online (CAN-DO) program and Healthy Living online course in people with Dementia, run by Emory University at 1 site in United States.
Trial summary
This study is designed to learn more about ways to promote caregiver mastery online. 270 dementia family caregivers will be enrolled and randomized to take the CAN-DO online course immediately or after a waiting period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Caregiver as Navigator: Develop Skills Online (CAN-DO) program and Healthy Living online course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2024to Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family member or friend providing at least 4 hours per week of informal care for a community-dwelling person living with ADRD
- 18 years or older
- Has internet access
- Does not have to co-reside with the individual
- Understands, speaks, and reads English
Who cannot join
- Family caregiver plans to move care recipient to an institutional setting within the next six months
- Care recipient currently enrolled in hospice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mia Chester contact
United States1 site, 1 recruiting
- Recruiting
Emory Roybal Center for Dementia Caregiving Mastery
Atlanta, Georgia, 30322
Mia Chester, mia.chester@emory.edu
Carolyn Clevenger, RN, DNP
About this study
Official title: Caregiver as Navigator: Develop Skills Online (CAN-DO) Developing Dementia Family Caregiver Mastery for Navigating Complex Health, Social Service, Legal, Financial, and Family Systems
This study is designed to learn more about ways to promote caregiver mastery online. 270 dementia family caregivers will be enrolled and randomized to take the CAN-DO online course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.
Read the detailed description
Family members and friends are the core of the uncoordinated system of care that tenuously maintains persons living with dementia in their community settings and delays their placement into more costly settings of institutional care, providing more contributed and out of pocket care support than Medicare and Medicaid combined.
The CAN-DO program fills a significant gap in caregiver psychoeducation programming by focusing not principally on day-to-day care management but on the many substantial system navigation tasks that caregivers assume. Supported by preliminary efficacy data, CAN-DO will employ state-of-the art asynchronous interactive learning methods to enhance caregivers' mastery of skills and confidence to navigate healthcare and other (legal, financial, social service, and family) systems that are crucial to the continued community living of persons affected with dementia illnesses.
This study will enroll 270 dementia family caregivers who will be randomized to take the CAN-DO course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.
- Conditions
- Dementia
- Being tested
- Caregiver as Navigator: Develop Skills Online (CAN-DO) program, Healthy Living online course
- Keywords
- Caregiver, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver as Navigator: Develop Skills Online (CAN-DO) programOther
Also called CAN-DO
Online, asynchronous psychoeducation program for dementia family caregivers. The program is meant to enhance caregivers' knowledge and skills for navigating healthcare, financial, legal, and family systems.
The program has three main sections.
- The first section provides information and how to prepare for using the healthcare system and community-based services in dementia care and support.
- The second provides information about how to be more effective when using the financial and legal system either for yourself or your person.
- The third section of the course provides information about ways to manage and navigate family dynamics present in various caregiving scenarios more effectively.
Healthy Living online courseOther
Online program for dementia family caregivers about "Healthy Living" for the first 4 months post-randomization.
| Study group | Role | What they receive |
|---|---|---|
| CAN-DO Immediate program group | Experimental | Each participant will be engaged in a baseline interview. Subsequently, each will be asked to take part in follow-up interviews at points 2, 4, 6, and 8 months following the launch of their cohort. Receives: Other: Caregiver as Navigator: Develop Skills Online (CAN-DO) program |
| Attention Control program group | Active comparator | Participants will receive an online course about "Healthy Living" for the first 4 months after randomization.
After the Attention Control participants complete their 4-month interview, they will be invited to participate in the CAN-DO program. Receives: Other: Caregiver as Navigator: Develop Skills Online (CAN-DO) program; Other: Healthy Living online course |
| Usual care group | Active comparator | Participants randomized to the Usual care group will not receive intervention from the study but after they complete their 4-month interview, they will be invited to participate in the CAN-DO program. Receives: Other: Caregiver as Navigator: Develop Skills Online (CAN-DO) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pearlin Caregiver Stress Scales score
This primary outcome will measure Caregiver Mastery (including Competence, Confidence, Management of Situation). The Pearlin caregiver scale includes 8 items, with a rating from 1-4 for each of them. Total possible score range is 8-32. Higher score correlates with better outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Change in Caregiver Assessment of Behavioral Skill scale score
This study outcome will also measure Caregiver Mastery. Caregiver Assessment of Behavioral Skills score will be assessed using the Fortinsky scale that includes 17 items rated from 0-3 each. Possible score range is 0-51. Higher score correlates with better outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Change in State-Trait Anxiety Scale score
This outcome will measure Caregiver Emotional Wellbeing. The State-Trait Anxiety Scale includes 20 items, each of them rated 1-4. Total possible score range 20-80 with higher score correlated with better study outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Change in Perceived Stress Scale score
This outcome will measure Caregiver Emotional Wellbeing. The Perceived Stress Scale includes 10 items, each of them rated 1-5, with a total possible score 10-50. Lower score correlates with better study outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Change in Caregiver Burden Index
This outcome will measure Caregiver Emotional Wellbeing. The caregiver burden Index includes 22 items, each of them rated 0-4, with a total possible score 0-88. Lower score correlates with better study outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Change in Dyadic Relationship Scale score
This outcome will assess Caregiver Emotional Wellbeing. The Dyadic Relationship Scale includes 11 items rated from 1 to 4, with a total possible score range 11-44. Higher score correlates with better outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Secondary outcomes (2)
Change in Revised Memory and Behavior Problem Checklist score
This outcome will assess Care Recipient Quality of Life. Total possible score: 0-96; Higher score correlates with worse outcome.
Measured: Baseline, 2, 4, 6, and 8 months post-intervention
Change in Quality of Life in Alzheimer's score
This outcome will assess Care Recipient Quality of Life. The total possible score is 13-52; Higher score correlates with better outcome.
Measured: Baseline, 2, 4, 6, and 8 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 posted20 Dec 2023
- Study start26 Dec 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
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
- NCT06177990
- Sponsor's protocol ID
- STUDY00006261
- Other IDs
- 1R01AG082833-01
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified aggregate data will be shared. Transcripts from interviews with patients and healthcare providers will be de-identified and sensitive content redacted where identification is plausible. These de-identified and redacted transcripts and coding summaries will be shared. All shared data sets and metadata will be made publicly available through Emory's Dataverse data repository. Documentation and support materials (e.g., survey questions with value sets and interview questions).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver as Navigator: Develop Skills Online (CAN-DO) Developing Dementia Family Caregiver Mastery for Navigating Complex Health, Social Service, Legal, Financial, and Family Systems
- ClinicalTrials.gov ID
- NCT06177990
- Acronym / sponsor ID
- STUDY00006261
- Conditions
- Dementia
- Keywords
- Caregiver, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Dec 2023 (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 is designed to learn more about ways to promote caregiver mastery online. 270 dementia family caregivers will be enrolled and randomized to take the CAN-DO online course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.
Detailed description
Family members and friends are the core of the uncoordinated system of care that tenuously maintains persons living with dementia in their community settings and delays their placement into more costly settings of institutional care, providing more contributed and out of pocket care support than Medicare and Medicaid combined.
The CAN-DO program fills a significant gap in caregiver psychoeducation programming by focusing not principally on day-to-day care management but on the many substantial system navigation tasks that caregivers assume. Supported by preliminary efficacy data, CAN-DO will employ state-of-the art asynchronous interactive learning methods to enhance caregivers' mastery of skills and confidence to navigate healthcare and other (legal, financial, social service, and family) systems that are crucial to the continued community living of persons affected with dementia illnesses.
This study will enroll 270 dementia family caregivers who will be randomized to take the CAN-DO course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAN-DO Immediate program group | Experimental | Other: Caregiver as Navigator: Develop Skills Online (CAN-DO) programEach participant will be engaged in a baseline interview. Subsequently, each will be asked to take part in follow-up interviews at points 2, 4, 6, and 8 months following the launch of their cohort. |
| Attention Control program group | Active comparator | Other: Caregiver as Navigator: Develop Skills Online (CAN-DO) program, Other: Healthy Living online courseParticipants will receive an online course about "Healthy Living" for the first 4 months after randomization. After the Attention Control participants complete their 4-month interview, they will be invited to participate in the CAN-DO program. |
| Usual care group | Active comparator | Other: Caregiver as Navigator: Develop Skills Online (CAN-DO) programParticipants randomized to the Usual care group will not receive intervention from the study but after they complete their 4-month interview, they will be invited to participate in the CAN-DO program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Family member or friend providing at least 4 hours per week of informal care for a community-dwelling person living with ADRD
- 18 years or older
- Has internet access
- Does not have to co-reside with the individual
- Understands, speaks, and reads English
Key exclusion criteria (2 listed)
- Family caregiver plans to move care recipient to an institutional setting within the next six months
- Care recipient currently enrolled in hospice
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 |
|---|---|---|
| Caregiver as Navigator: Develop Skills Online (CAN-DO) programAlso: CAN-DOOnline, asynchronous psychoeducation program for dementia family caregivers. The program is meant to enhance caregivers' knowledge and skills for navigating healthcare, financial, legal, and family systems. The program has three main sections. * The first section provides information and how to prepare for using the healthcare system and community-based services in dementia care and support. * The second provides information about how to be more effective when using the financial and legal system either for yourself or your person. * The third section of the course provides information about ways to manage and navigate family dynamics present in various caregiving scenarios more effectively. | Other | Attention Control program group, CAN-DO Immediate program group, Usual care group |
| Healthy Living online courseOnline program for dementia family caregivers about "Healthy Living" for the first 4 months post-randomization. | Other | Attention Control program group |
Primary outcome
Change in Pearlin Caregiver Stress Scales score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
This primary outcome will measure Caregiver Mastery (including Competence, Confidence, Management of Situation). The Pearlin caregiver scale includes 8 items, with a rating from 1-4 for each of them. Total possible score range is 8-32. Higher score correlates with better outcome.
Change in Caregiver Assessment of Behavioral Skill scale score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
This study outcome will also measure Caregiver Mastery. Caregiver Assessment of Behavioral Skills score will be assessed using the Fortinsky scale that includes 17 items rated from 0-3 each. Possible score range is 0-51. Higher score correlates with better outcome.
Change in State-Trait Anxiety Scale score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
This outcome will measure Caregiver Emotional Wellbeing. The State-Trait Anxiety Scale includes 20 items, each of them rated 1-4. Total possible score range 20-80 with higher score correlated with better study outcome.
Change in Perceived Stress Scale score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
This outcome will measure Caregiver Emotional Wellbeing. The Perceived Stress Scale includes 10 items, each of them rated 1-5, with a total possible score 10-50. Lower score correlates with better study outcome.
Change in Caregiver Burden Index
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
This outcome will measure Caregiver Emotional Wellbeing. The caregiver burden Index includes 22 items, each of them rated 0-4, with a total possible score 0-88. Lower score correlates with better study outcome.
Change in Dyadic Relationship Scale score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
This outcome will assess Caregiver Emotional Wellbeing. The Dyadic Relationship Scale includes 11 items rated from 1 to 4, with a total possible score range 11-44. Higher score correlates with better outcome.
2 secondary outcomes
Change in Revised Memory and Behavior Problem Checklist score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
Change in Quality of Life in Alzheimer's score
Time frame: Baseline, 2, 4, 6, and 8 months post-intervention
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 12 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified aggregate data will be shared. Transcripts from interviews with patients and healthcare providers will be de-identified and sensitive content redacted where identification is plausible. These de-identified and redacted transcripts and coding summaries will be shared. All shared data sets and metadata will be made publicly available through Emory's Dataverse data repository. Documentation and support materials (e.g., survey questions with value sets and interview questions).
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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.
Mia Chester contact
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 Caregiver as Navigator: Develop Skills Online (CAN-DO) program and Healthy Living 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jan 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?
Contact Carolyn Clevenger, RN, DNP (404-712-2394, carolyn.clevenger@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pearlin Caregiver Stress Scales score (time frame: Baseline, 2, 4, 6, and 8 months post-intervention). The study lists 6 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 12 Jan 2026.