Alzheimer's Disease and Related Dementias (ADRD)Co-CARE-ADNCT05281744
Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias
A study testing Dementia Care Consultation program in people with Alzheimer's Disease and Related Dementias (ADRD), run by Harvard Pilgrim Health Care at 1 site in United States.
Trial summary
This is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease and Related Dementias (ADRD)
- What is being tested?
- Dementia Care Consultation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,160 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 15 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Member of Tufts Health Plan Medicare Advantage plan
- Medical and pharmacy insurance coverage in at least the prior 12 months
- Have ≥1 ICD-10-CM diagnosis code for ADRD or dispensing for pharmacological treatment for ADRD in the prior 12 months
- Age 18 years or older
- Assume primary responsibility for members
Who cannot join
- Reside in a nursing home or skilled nursing facility
- Enrolled in a hospice program
- Receiving or have received the Dementia Care Consultation program as part of the existing program at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)
This is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. The study population will include community-dwelling Medicare Advantage members living with ADRD and their care partners. Outcomes will be healthcare utilization outcomes of individuals with ADRD and include emergency department visits, outpatient visits, avoidable emergency department visits, and admission to long-term care facilities.
- Being tested
- Dementia Care Consultation program
- Keywords
- dementia, informal caregiver, care consultation, care coordination
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Care Consultation programBehavioural
The Dementia Care Consultation program uses a telephone-based intervention to provide an in-depth, personalized service for individuals living with ADRD and their care partners. It consists of comprehensive needs assessments, creation and implementation of personalized care plans, monitoring and revising care plans, disease education and support coaching, referrals to community-based organizations for service and support, and access to assistance.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Care Consultation program | Experimental | The Dementia Care Consultation program provides an in-depth, personalized service for individuals and families facing ADRD. Receives: Behavioral: Dementia Care Consultation program |
| Routine Care | No intervention | Members randomized into the control group will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause emergency department visits
Number of all-cause emergency department visits per member living with ADRD over the 12-month follow-up period.
Measured: by 12 months
All-cause emergency department visits
Number of all-cause emergency department visits per member living with ADRD over the 6-month follow-up period.
Measured: by 6 months
Secondary outcomes (6)
Outpatient visits
Number of outpatient visits per member living with ADRD over the 12-month follow-up period.
Measured: by 12 months
Outpatient visits
Number of outpatient visits per member living with ADRD over the 6-month follow-up period.
Measured: by 6 months
Avoidable emergency department visits
Number avoidable emergency department visits (defined using the validated New York University ED visit algorithm) per member living with ADRD over the 12-month follow-up period.
Measured: by 12 months
Avoidable emergency department visits
Number avoidable emergency department visits (defined using the validated New York University ED visit algorithm) per member living with ADRD over the 6-month follow-up period.
Measured: by 6 months
Admission to long-term care facilities
Number of members living with ADRD with the first admission to long-term care facilities over the 12-month follow-up period.
Measured: by 12 months
Admission to long-term care facilities
Number of members living with ADRD with the first admission to long-term care facilities over the 6-month follow-up period.
Measured: by 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start27 May 2022
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease and Related Dementias (ADRD)Studies of the same condition, open and under way.
- 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
- 2,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Health Plan, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Xiaojuan Li, Harvard Pilgrim Health Care
- Investigators
- Xiaojuan Li, PhD MSPH, Principal investigator, Harvard Pilgrim Health Care InstituteRichard Platt, MD MS, Principal investigator, Harvard Pilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281744
- Sponsor's protocol ID
- AH000843
- Other IDs
- 5U54AG063546-03
- Acronym
- Co-CARE-AD
- Status last verified
- Oct 2024
- First submitted
- 25 Feb 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)
- ClinicalTrials.gov ID
- NCT05281744
- Acronym / sponsor ID
- Co-CARE-AD / AH000843
- Keywords
- dementia, informal caregiver, care consultation, care coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,160 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Tufts Health Plan, National Institute on Aging (NIA)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 16 Mar 2022 (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 is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. The study population will include community-dwelling Medicare Advantage members living with ADRD and their care partners. Outcomes will be healthcare utilization outcomes of individuals with ADRD and include emergency department visits, outpatient visits, avoidable emergency department visits, and admission to long-term care facilities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia Care Consultation program | Experimental | Behavioral: Dementia Care Consultation programThe Dementia Care Consultation program provides an in-depth, personalized service for individuals and families facing ADRD. |
| Routine Care | No intervention | –Members randomized into the control group will receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Member of Tufts Health Plan Medicare Advantage plan
- Medical and pharmacy insurance coverage in at least the prior 12 months
- Have ≥1 ICD-10-CM diagnosis code for ADRD or dispensing for pharmacological treatment for ADRD in the prior 12 months
- Age 18 years or older
- Assume primary responsibility for members
Key exclusion criteria (3 listed)
- Reside in a nursing home or skilled nursing facility
- Enrolled in a hospice program
- Receiving or have received the Dementia Care Consultation program as part of the existing program at the time of enrollment
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 |
|---|---|---|
| Dementia Care Consultation programThe Dementia Care Consultation program uses a telephone-based intervention to provide an in-depth, personalized service for individuals living with ADRD and their care partners. It consists of comprehensive needs assessments, creation and implementation of personalized care plans, monitoring and revising care plans, disease education and support coaching, referrals to community-based organizations for service and support, and access to assistance. | Behavioural | Dementia Care Consultation program |
Primary outcome
All-cause emergency department visits
Time frame: by 12 months
Number of all-cause emergency department visits per member living with ADRD over the 12-month follow-up period.
All-cause emergency department visits
Time frame: by 6 months
Number of all-cause emergency department visits per member living with ADRD over the 6-month follow-up period.
6 secondary outcomes
Outpatient visits
Time frame: by 12 months
Outpatient visits
Time frame: by 6 months
Avoidable emergency department visits
Time frame: by 12 months
Avoidable emergency department visits
Time frame: by 6 months
Admission to long-term care facilities
Time frame: by 12 months
Admission to long-term care facilities
Time frame: by 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 22 Jan 2026.
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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.
Xiaojuan Li, PhD MSPH principal investigator
Harvard Pilgrim Health Care Institute
Richard Platt, MD MS principal investigator
Harvard Pilgrim Health Care Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Care Consultation program in people with Alzheimer's Disease and Related Dementias (ADRD), run by Harvard Pilgrim Health Care 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 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 22 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?
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?
All-cause emergency department visits (time frame: by 12 months). The study lists 2 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 22 Jan 2026.