NCT04631120

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Integrated Dementia Practice Unit Design	* 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.
OTHER	Standard of Care	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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2021-10-01
• Completion: 2026-10-01
• First posted: 2020-11-17
• Last updated: 2022-01-11

Locations

1 site across 1 country: United States