The Rationale and Design of Behavioral Interventions for Management of Agitation in Dementia in a Multi-Site Clinical Trial

Article type: Research Article

Authors: Zarei, Shadi^{a; b} | Colman, Sarah^{a; b} | Rostas, Aviva^{a; b} | Burhan, Amer M.^{c; g} | Chu, Li^{a; b} | Davies, Simon JC^{a; b} | Derkach, Peter^d | Elmi, Sarah^g | Hussain, Maria^h | Gerretsen, Philip^{a; b} | Graff-Guerrero, Ariel^{a; b} | Ismail, Zahinoor^e | Kim, Donna^{a; b} | Krisman, Linda^a | Moghabghab, Rola^{a; b} | Mulsant, Benoit H.^{a; b} | Nair, Vasavan^f | Pollock, Bruce G.^{a; b} | Rej, Soham^f | Simmons, Jyll^a | Van Bussel, Lisa^c | Rajji, Tarek K.^{a; b; i} | Kumar, Sanjeev^{a; b; *} | on behalf of the StaN Study Group¹

Affiliations: [a] Centre for Addiction and Mental Health, Toronto, Ontario, Canada | [b] Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada | [c] Department of Psychiatry, Western University, London, Ontario, Canada | [d] Ukrainian Canadian Care Centre, Toronto, Ontario, Canada | [e] Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada | [f] Department of Psychiatry, McGill University, Montreal, Quebec, Canada | [g] Ontario Shores Centre for Mental Health Sciences, Toronto, Ontario, Canada | [h] Department of Psychiatry, Queen’s University, Kingston, Ontario, Canada | [i] Toronto Dementia Research Alliance, University of Toronto, Toronto, Ontario, Canada

Correspondence: [*] Correspondence to: Sanjeev Kumar, 6324, 80 Workman Way, Toronto, ON M6J1H4, Canada. Tel.: 416-535-8501; E-mail: [email protected].

Note: [1] Saima Awan, Amer M. Burhan, Sarah Colman, Susmita Chandramouleeshwaran, Samira Choudhury, Li Chu, Steve Crawford, Simon Davies, Peter Derkach, Breno Diniz, Sarah Elmi, Philip Gerretsen, Ariel Graff-Guerrero, Maria Hussain, Zahinoor Ismail, Donna Kim, Dunja Knezevic, Linda Krisman, Sanjeev Kumar, Paul Kurdyak, Lillian Lourenco, Ashley Melichercik, Rola Moghabghab, Benoit H. Mulsant, Vasavan Nair, Claire de Oliveira, Shima Ovaysikia, Bruce G. Pollock, Tarek K. Rajji, Soham Rej, Aviva Rostas, Dallas Seitz, Jyll Simmons, David Streiner, Christopher Uranis, Lisa Van Bussel, Vincent Woo, Shadi Zarei.

Abstract: Background:Agitation and aggression are common in patients with Alzheimer’s disease and related dementias and pose a significant burden on patients, caregivers, and the healthcare systems. Guidelines recommend personalized behavioral interventions as the first-line treatment; however, these interventions are often underutilized. The Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia (StaN) study (ClinicalTrials.gov Identifier # NCT0367220) is a multisite randomized controlled trial comparing an Integrated Care Pathway, that includes a sequential pharmacological algorithm and structured behavioral interventions, with treatment-as-usual to treat agitation in dementia in long-term care and inpatient settings. Objective:To describe the rationale and design of structured behavioral interventions in the StaN study. Methods:Structured behavioral interventions are designed and implemented based on the following considerations: 1) personalization, 2) evidence base, 3) dose and duration, 4) measurement-based care, and 5) environmental factors and feasibility. Results:The process to design behavioral interventions for each individual starts with a comprehensive assessment, followed by personalized, evidence-based interventions delivered in a standardized manner with ongoing monitoring of global clinical status. Measurement-based care is used to tailor the interventions and integrate them with pharmacotherapy. Conclusion:Individualized behavioral interventions in patients with dementia may be challenging to design and implement. Here we describe a process to design and implement individualized and structured behavioral interventions in the context of a multisite trial in long-term care and inpatient settings. This process can inform the design of behavioral interventions in future trials and in clinical settings for the treatment of agitation in dementia.

Keywords: Agitation, behavioral interventions, dementia, randomized controlled trial

DOI: 10.3233/JAD-215261

Journal: Journal of Alzheimer's Disease, vol. 86, no. 2, pp. 827-840, 2022