Aggression, Alzheimer Dementia (AD), Alzheimer's Disease
Conditions
Keywords
Aggression, Agitation, Alzheimer's disease, Integrated Care Pathway, StaN, Dementia
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.
Interventions
BEHAVIORALNon-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.
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.
Sponsors
Centre for Addiction and Mental Health
University of Calgary
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Douglas Mental Health University Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and assessors will be blind to the group assignment.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency) | Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks | The Cohen-Mansfield Agitation Inventory (CMAI) Frequency score measures burden of agitation in patients with dementia. CMAI-frequency score ranges between 29 to 203, higher scores indicate worsening of symptoms. |
| The proportion of participants on polypharmacy | Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks | The percentage and the total number of participants on 2 or more psychotropics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The impact of the ICP on falls | Every 2 weeks | Recording the number of falls |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORTarek Rajji, MD
Centre for Addiction and Mental Health
Outcome results
None listed