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Clinical Trials/NCT04631120
NCT04631120
Withdrawn
Not Applicable

Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study

Vanderbilt University Medical Center1 site in 1 countryOctober 2021
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Vanderbilt University Medical Center
Locations
1
Primary Endpoint
Days Alive and At Home
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

Dementia patients experience memory and other cognitive function deterioration leading to loss of independent function. Care required for dementia is multifactorial, spanning cognitive, behavioral, emotional, and physical symptoms, and complicates aspects of daily living. This places tremendous strain on caregivers who, in turn, experience their own increased physical and mental health needs. The current care model focuses primarily on patient pharmacological management but misses the mark on caregiver focus and collaboration. Building on systematic reviews and existing evidence gaps in information and support for patient/caregiver dyads, dealing with behavioral symptoms, referrals to available community resources, and multidisciplinary team care with improved coordination and communication17, the study investigators propose a patient- and caregiver-targeted Integrated Dementia Practice Unit (IDPU) model of care. IDPU integrates disconnected care under a centralized specialty team, providing monitoring, education, individualized support, and proactive, ongoing collaboration and coaching using technology and home/virtual visits for maximal impact. Days alive at home (DAAH) best captures quality of life (QOL) for the index dementia patient, from the perspective of both the healthcare system and the caregiver, and degree of support for the caregiver and is often an outcome in assessing health delivery. The study investigators hypothesize IDPU will increase DAAH and improve patient-level (behavioral; depressive symptoms; chronic disease management) and caregiver-level (strain, depressive symptoms, social support) outcomes relative to an Educational+ model, merging a standard care design with additional education support for patients/caregivers and their Primary Care Providers (PCP). This study seeks to (a) improve and establish IDPU feasibility of the in the feasibility phase, (b) determine if IDPU is more effective than Education+ in increasing DAAH and patient- and caregiver-level outcomes, and (c) determine if benefits of IDPU are more or less pronounced in vulnerable subgroups in the full-scale study.

Registry
clinicaltrials.gov
Start Date
October 2021
End Date
October 2026
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Howard Kirshner

Vice Chair of Neurology, Professor and Director of Stroke Center

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Days Alive and At Home

Time Frame: 12 months

Our primary outcome is days alive at home (DAAH) for an index dementia patient within 1-year of enrollment (defined as days NOT in a hospital, extended care facility, in-patient rehabilitation, hospice, or respite care facility since enrollment).

Secondary Outcomes

  • Perceived Social Support of Caregivers(24 months)
  • Number of Neurobehavioral Changes(24 months)
  • Percent of Participants Achieving Chronic Disease Control Based on Risk Factor Averages(24 months)
  • Number of Health Resources Utilized(24 months)
  • Assessment of Perceived Strain in Caregivers(24 months)
  • Assessment of Caregiver Stress(24 months)

Study Sites (1)

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