Clinical trial NCT04631120: Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study
Official title: Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria include:

* Alzheimer's Disease or Vascular Dementia diagnosis provided by a study investigator
* 2 or 3 on the Clinical Dementia Rating Scale at time of enrollment
* Mini Mental Status Examination score of \>10 or \<25 administered at the time of enrollment
* Willingness and ability to provide patient or surrogate consent, and since caregiver cooperation will be an integral part of this study, an ability to provide caregiver consent to participate

Exclusion criteria include:

* Individuals with Mild Cognitive Impairment
* Institutionalized individuals (extended care facility, nursing home, group home, or similar institutional setting)
* Individuals who in the opinion of the investigator cannot be enrolled or followed due to geographic or other constraints

Primary outcomes:
measure: Days Alive and At Home
timeFrame: 12 months
Secondary outcomes:
measure: Number of Neurobehavioral Changes
timeFrame: 24 months
measure: Number of Health Resources Utilized
timeFrame: 24 months
measure: Percent of Participants Achieving Chronic Disease Control Based on Risk Factor Averages
timeFrame: 24 months
measure: Perceived Social Support of Caregivers
timeFrame: 24 months
measure: Assessment of Perceived Strain in Caregivers
timeFrame: 24 months
measure: Assessment of Caregiver Stress
timeFrame: 24 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Howard Kirshner, MD
role: PRINCIPAL_INVESTIGATOR
References: