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

NCT04631120 | Withdrawn DMC

• 1 other identifier: 55555
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Days Alive and At Home

  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).

  12 months

Secondary Outcomes (6)

• Number of Neurobehavioral Changes

  24 months

• Number of Health Resources Utilized

  24 months

• Percent of Participants Achieving Chronic Disease Control Based on Risk Factor Averages

  24 months

• Perceived Social Support of Caregivers

  24 months

• Assessment of Perceived Strain in Caregivers

  24 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

The proposed arm will involve an initial assessment using the Clinical Dementia Rating (CDR) Scale and Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score for patients and Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard educational material from the AA and Association for the Advancement of Retired Persons (AARP). Two phone sessions with a study nurse will occur post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment; a summary of these and professional education on national evidence-based guidelines will be mailed to the patient's PCP of record. Education provided in this arm will be both patient- and caregiver-centered.

Other: Standard of Care

Integrated Dementia Practice Unit Arm

EXPERIMENTAL

The integrated practice unit design is a coordinated, team-based, comprehensive, technology enabled, family focused care delivery design comprised of: * Dementia Central: Nurses, physicians, psychologists, social workers, and other relevant healthcare providers that will meet monthly to review participants progress and issues. Telehealth visits would facilitate home care. * Dementia Mobile: A nurse and lay health educator team will perform monthly visits, conduct assessments of subjects and provide education/coaching. * Dementia Link: Technologies that facilitate communication between Dementia Central and Dementia Mobile and foster proactive collaboration/coaching for study subjects include an mHealth software that allows for real time intervention/communication between professional teams and dyads, combined with management of dyads for multiple parameters like health metrics, behavioral measures and stress management and a portal tailored to specific clinical needs.

Other: Integrated Dementia Practice Unit Design

Interventions

Integrated Dementia Practice Unit Design OTHER

* Dementia Central: monthly review of participant progress * Dementia Mobile: monthly nurse/lay health educator visits for assessments, education and coaching * Dementia Link: communication between Dementia Central and Dementia Mobile using the eTransX mHealth platform and HealthStream educational interface for care providers and the patient/caregiver dyad.

Integrated Dementia Practice Unit Arm

Standard of Care OTHER

Standard clinical practices of the physician and institution including an initial assessment, Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard patient- and caregiver-centered educational material. Two phone sessions with a study nurse post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alzheimer's Disease or Vascular Dementia diagnosis provided by a study investigator
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Howard Kirshner, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Neurology, Professor and Director of Stroke Center

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2021
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)