Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

Alzheimer's Disease Clinical Trial

— StaN  

Official title:

Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03672201
• Other study ID #: 1482
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 187
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Providence Care	Kingston	Ontario
Canada	LAWSON Health Research Institute	London	Ontario
Canada	Douglas Hospital Research Centre	Montréal	Quebec
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	Ontario Shores Centre for Mental Health Sciences	Whitby	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Douglas Mental Health University Institute, Lawson Health Research Institute, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency)	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.	Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks
Primary	The proportion of participants on polypharmacy	The percentage and the total number of participants on 2 or more psychotropics	Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks
Secondary	The impact of the ICP on falls	Recording the number of falls	Every 2 weeks