Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT04631120
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.
Study:
NCT04631120
Study Brief:
Protocol Section:
NCT04631120