NCT03672201

Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The object of this study to evaluation an Integrated Care Pathway (ICP) to treat Aggression and Agitation in Alzheimer's disease (AD-AA). The ICP is an algorithmic approach to use psychotropic medications and non-pharmacological interventions based on standardized assessments which fosters measurement-based decision making. This study will assess the efficacy of the ICP to treat AD-AA and its impact on inappropriate use of medications in inpatient settings and Long-Term Care Facilities (LTCF). The investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 LTCFs) to ICP vs. Treatment As Usual. Further, this study will also examine the impact of the ICP on caregiver burden and undertake a cost-effectiveness analysis of the ICP for patients with AD-AA.

Detailed description

This project will take place in 7 sites across two settings: Inpatient (CAMH in Toronto, Douglas Hospital Research Centre in Montreal, Parkwood Institute in London, and the University of Calgary in Calgary); and LTCFs affiliated with CAMH in Toronto and Parkwood Institute in London. After a project initiation phase of 6 months, the investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 in LTCFs) to ICP vs.TAU. In this randomized control trial (RCT) phase of the project, participants will be treated for 12 weeks. There will be two primary outcome measures: (i) the Cohen-Mansfield Agitation Inventory (CMAI) Total Frequency Score (CMAI-frequency) and (ii) the proportion of participants on polypharmacy. These measures will be conducted at baseline, end of non-pharmacological intervention phase, the mid-point of pharmacological interventions and end of RCT. Neuropsychiatric Inventory-Questionnaire (NPI-C) will be used to assess global burden of neuropsychiatric symptoms at baseline, end of non-pharmacological intervention phase and exit. The modified Clinical Global Impression of Change (CGIC) will also be measured at predetermined time points throughout the 12 weeks to determine response as defined by CGIC \< 3. CGIC is a 7-point Likert scale to rate each patient along a continuum from marked improvement to marked worsening, based on global clinical impression. Rating of \< 3 indicates moderate or marked improvement in agitation as compared to baseline. At the end of the RCT, each participant will be naturalistically followed up for an additional 6 months during which the investigators will collect both clinical and health economics data from the Institute for Clinical Evaluative Sciences (ICES) database. The RCT phase will be completed after 18 months, and during the last part of this project, the investigators will analyze the data from the RCT and complete all naturalistic follow-ups.

Conditions

• Alzheimer's Disease
• Alzheimer Dementia (AD)
• Aggression

Interventions

Type	Name	Description
BEHAVIORAL	Non-Pharmacological Intervention	The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant.
OTHER	Pharmacological Intervention	The medication algorithm provides recommendations to the treatment team about algorithmic treatment and assessments as per the ICP but ultimately the decision to prescribe any particular intervention will be the treatment team's decision and the recommendations of the research team for ICP arm will not be binding for the treatment team.

Timeline

• Start date: 2018-11-01
• Primary completion: 2023-03-31
• Completion: 2027-12-31
• First posted: 2018-09-14
• Last updated: 2026-04-13

Locations

6 sites across 1 country: Canada