The Calgary Movement Disorders Advanced Care Pilot Program (ACT for PD)

The goal of this clinical trial is to analyse the effect of palliative care interventions on quality of life, patient satisfaction, carepartner burden and health care utilization patterns in patients living with parkisonism and their carepartners.

Participants will:

• Receive multidisciplinary palliative care.
• Answer questions related to the quality of life, patient satisfaction, carepartner burden and health care utilization patterns.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease and Parkinsonism
• Intervention / Treatment: Behavioral: Palliative care

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica Bruno, MD, MPH; Phone Number: 4039194262; Email: veronica.bruno@ucalgary.ca
• Study Contact Backup: Name: Karla Cantu Flores, MD; Phone Number: 4032107542; Email: karla.cantuflores1@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Movement Disorder Program, Foothills Medical Center, Alberta Health Services
      • Contact: Veronica Bruno, MD, MPH; Phone Number: 4032207875; Email: veronica.bruno@ucalgary.ca
      • Sub-Investigator: Karla Cantu Flores, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants who have a PD diagnosis or another PDRD diagnosis (multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, or Lewy body dementia)
• Participants who have moderate to high PC needs based on the Palliative Care Needs Assessment Tool (PC-NAT)
• Participants who are between 20 and 100 years old

Exclusion Criteria:

• Immediate and urgent palliative care needs. These patients will be offered appropriate services immediately
• Participants who have other illnesses that could require PC e.g. metastatic cancer
• Participants already receiving PC and/or hospice
• Patients with a diagnosis of severe cognitive impairment (Montreal Cognitive Assessment <10). These patients will be offered appropriate services. Care partners can participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Palliative care; Participants will receive palliative care.

Behavioral: Palliative care; It is a pilot model of outpatient clinical care for patients in advanced stages of PDRD that will allow earlier access to PC in this population. PC visits will be in person or by telemedicine every three months and complemented with phone calls by different team members when needed as defined by the PC team. The typical visit duration will be 2 to 2.5 hours and address nonmotor symptoms, goals of care, anticipatory guidance, difficult emotions, and carepartner support. Providers will communicate in-person or via notes during the clinic visit to increase interdisciplinary coordination and meet at the end of the day for discussion including follow-up plans. The team will consist of a neurologist, a registered nurse with palliative care experience and training, a psychology counselor, a social worker, spiritual counselor and a research assistant.; Other Names: Advanced care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Quality of Life Alzheimer's Disease (QOL-AD)	The QOL-AD is a 13-item questionnaire designed to provide both a patient and a caregiver report of the quality of life (QOL), it uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks.	Every 3 months for 2 years
Changes in 12-Item Zarit Burden Interview (ZBI-12)	ZBI-12 is validated as a screening tool for advanced illness. The ZBI-12 is rated on a 12 items scale, with the severity of burden using a range of responses from 0 to 4 points per item and a total score range of 0 to 48. Scoring 0-10 is considered as a no to mild burden; 10-20, a mild to moderate burden and >20, a high burden. It measures changes in physical, emotional, social, and financial problems that can be experienced by family caregivers.	Every 3 months for 2 years
Changes in Health Care Utilization survey	We will perform a Health Service Utilization Survey to measure changes in the number of hospitalizations, emergency room visits, home health services, and nursing home placement.	Every 3 months for 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Edmonton Symptom Assessment Scale revised for Parkinson's Disease (ESAS-PD)	The ESAS is a comprehensive, yet brief and practical self-reporting tool of symptom severity (intensity) for nine common symptoms of advanced cancer (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath), with the option of adding a tenth patient-specific symptom. It rates the severity of each symptom on a 0 to 10 scale, where 0 represents the absence (or best possible intensity) of the symptom and 10 represents the worst possible severity.	Every 3 months for 2 years
Changes in the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp-12)	The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) is the most widely used measure of spiritual well-being among those with long-term illness. The FACIT-Sp comprises 12 statements, or items, each of which is rated on a 5-point scale by the respondent based on how true the item was during the past week, 0 for not at all, 1 for a little bit, 2 for somewhat, 3 for quite a bit and 5 for very much.	Every 3 months for 2 years
Semi-structured Qualitative Interview to receive Patient and Care Partner recommendations	It will be performed on patients and care partners for optimizing the palliative care services provided and delivery methods.	Every 3 months for 2 years

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 4, 2022
• Primary Completion (ANTICIPATED): November 4, 2024
• Study Completion (ANTICIPATED): November 4, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (ACTUAL): October 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Palliative Care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Movement Disorders; Parkinsonian Disorders
• Other Study ID Numbers: REB22-0545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No