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Completed

NCT Number: NCT05281744

Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias

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.

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Key information

Conditions

Alzheimer's Disease and Related Dementias (ADRD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Health Plan

Watertown, Massachusetts, 02472, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Community-dwelling Tufts Health Plan Medicare Advantage members with ADRD and their caregivers will be selected to participate in the trial based on the following inclusion/exclusion criteria:

Inclusion criteria

(for members with ADRD)

  • 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

Exclusion criteria

(for members with ADRD):

  • 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

Inclusion criteria

(for caregivers)

  • Age 18 years or older
  • Assume primary responsibility for members

Treatment and study plan

Dementia Care Consultation program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Outpatient visits

    Time frame: by 12 months

    Number of outpatient visits per member living with ADRD over the 12-month follow-up period.

  2. Outpatient visits

    Time frame: by 6 months

    Number of outpatient visits per member living with ADRD over the 6-month follow-up period.

  3. Avoidable emergency department visits

    Time frame: by 12 months

    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.

  4. Avoidable emergency department visits

    Time frame: by 6 months

    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.

  5. Admission to long-term care facilities

    Time frame: by 12 months

    Number of members living with ADRD with the first admission to long-term care facilities over the 12-month follow-up period.

  6. Admission to long-term care facilities

    Time frame: by 6 months

    Number of members living with ADRD with the first admission to long-term care facilities over the 6-month follow-up period.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • National Institute on Aging (NIA)
  • Tufts Health Plan

Registry information

Official study title

Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)

Acronym: Co-CARE-AD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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