Clinical trial NCT03672201: Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
Official title: Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Alzheimer Dementia (AD)
Aggression
Keywords: Aggression
Agitation
Alzheimer's disease
Integrated Care Pathway
StaN
Dementia
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Douglas Mental Health University Institute
First posted: 2018-09-14
Enrollment: 187
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. A clinical diagnosis of Dementia of Alzheimer's or Mixed type using the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) criteria
2. AD-AA as defined by Agitation in cognitive disorders; International Psychogeriatric Association provisional consensus clinical and research definition
3. Participant or substitute decision maker (SDM) able and willing to provide consent for enrollment in the study
4. 50 years or older
5. Medical stability to participate in the trial.

Exclusion Criteria:

1. Having dementia other than Alzheimer's or Mixed type.
2. DSM-5 diagnoses other than dementia that is thought to be significantly impacting the presentation of AD-AA such as delirium, bipolar disorder, or major depressive disorder.
3. Any other reason which in the opinion of study investigator will make the study participation intolerable for the participant.

Primary outcomes:
measure: Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency)
timeFrame: Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks
measure: The proportion of participants on polypharmacy
timeFrame: Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks
Secondary outcomes:
measure: The impact of the ICP on falls
timeFrame: Every 2 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Kingston
country: Canada
facility: Providence Care
state: Ontario
city: London
country: Canada
facility: LAWSON Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
city: Whitby
country: Canada
facility: Ontario Shores Centre for Mental Health Sciences
state: Ontario
city: Montréal
country: Canada
facility: Douglas Hospital Research Centre
state: Quebec
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Tarek Rajji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarei S, Colman S, Rostas A, Burhan AM, Chu L, Davies SJ, Derkach P, Elmi S, Hussain M, Gerretsen P, Graff-Guerrero A, Ismail Z, Kim D, Krisman L, Moghabghab R, Mulsant BH, Nair V, Pollock BG, Rej S, Simmons J, Van Bussel L, Rajji TK, Kumar S; StaN Study Group. The Rationale and Design of Behavioral Interventions for Management of Agitation in Dementia in a Multi-Site Clinical Trial. J Alzheimers Dis. 2022;86(2):827-840. doi: 10.3233/JAD-215261.