Caregiver as Navigator: Develop Skills Online (CAN-DO)
2 other identifiers
interventional
270
1 country
1
Brief 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. They will participate in interviews before and after the course; total time of study participation is 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2023
CompletedFirst Posted
Study publicly available on registry
December 20, 2023
CompletedStudy Start
First participant enrolled
December 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
January 12, 2026
January 1, 2026
3.2 years
December 11, 2023
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
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.
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.
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.
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.
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.
Baseline, 2, 4, 6, and 8 months post-intervention
Secondary Outcomes (2)
Change in Revised Memory and Behavior Problem Checklist score
Baseline, 2, 4, 6, and 8 months post-intervention
Change in Quality of Life in Alzheimer's score
Baseline, 2, 4, 6, and 8 months post-intervention
Study Arms (3)
CAN-DO Immediate program group
EXPERIMENTALEach 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 COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
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.
Online program for dementia family caregivers about "Healthy Living" for the first 4 months post-randomization.
Eligibility Criteria
You may qualify if:
- Family member or friend providing at least 4 hours per week of informal care for a community-dwelling person living with ADRD
- years or older
- Has internet access
- Does not have to co-reside with the individual
- Understands, speaks, and reads English
You may not qualify if:
- Family caregiver plans to move care recipient to an institutional setting within the next six months
- Care recipient currently enrolled in hospice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Aging (NIA)collaborator
- Emory Universitylead
Study Sites (1)
Emory Roybal Center for Dementia Caregiving Mastery
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Clevenger, RN, DNP
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 11, 2023
First Posted
December 20, 2023
Study Start
December 26, 2024
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Final data submission and release of data used in publications will occur approximately 8 and 12 months following the end of fieldwork, respectively. Datasets underlying publications will be shared at or prior to initial publication date. Data will not be published or will not be shared before the end of this award. Shared data will be preserved according to Emory's Dataverse data repository data retention policy. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
- Access Criteria
- Data will be available by controlled access only. Research participants will receive information about where and how data from this study will be shared during study enrollment procedures and in informed consent documents. Interview participants will be informed their data will be shared on Emory's Dataverse data repository with controlled access for future use. Participants who want to withdraw their data from the study prior to de-identification may contact the study team or the university's research administration office.
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).