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

Primary Purpose

Parkinson's Disease and Parkinsonism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Palliative care
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease and Parkinsonism focused on measuring Palliative Care

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palliative care

Arm Description

Participants will receive palliative care.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 12, 2022
Last Updated
October 28, 2022
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05599659
Brief Title
The Calgary Movement Disorders Advanced Care Pilot Program
Acronym
ACT for PD
Official Title
The Calgary Movement Disorders Advanced Care Pilot Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 4, 2022 (Anticipated)
Primary Completion Date
November 4, 2024 (Anticipated)
Study Completion Date
November 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease and Parkinsonism
Keywords
Palliative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The clinical trial is a prospective cohort study analysing 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palliative care
Arm Type
Experimental
Arm Description
Participants will receive palliative care.
Intervention Type
Behavioral
Intervention Name(s)
Palliative care
Other Intervention Name(s)
Advanced care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Quality of Life Alzheimer's Disease (QOL-AD)
Description
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.
Time Frame
Every 3 months for 2 years
Title
Changes in 12-Item Zarit Burden Interview (ZBI-12)
Description
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.
Time Frame
Every 3 months for 2 years
Title
Changes in Health Care Utilization survey
Description
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.
Time Frame
Every 3 months for 2 years
Secondary Outcome Measure Information:
Title
Changes in Edmonton Symptom Assessment Scale revised for Parkinson's Disease (ESAS-PD)
Description
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.
Time Frame
Every 3 months for 2 years
Title
Changes in the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp-12)
Description
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.
Time Frame
Every 3 months for 2 years
Title
Semi-structured Qualitative Interview to receive Patient and Care Partner recommendations
Description
It will be performed on patients and care partners for optimizing the palliative care services provided and delivery methods.
Time Frame
Every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Bruno, MD, MPH
Phone
4039194262
Email
veronica.bruno@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karla Cantu Flores, MD
Phone
4032107542
Email
karla.cantuflores1@ucalgary.ca
Facility Information:
Facility Name
Movement Disorder Program, Foothills Medical Center, Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Bruno, MD, MPH
Phone
4032207875
Email
veronica.bruno@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Karla Cantu Flores, MD
First Name & Middle Initial & Last Name & Degree
Veronica Bruno, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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The Calgary Movement Disorders Advanced Care Pilot Program

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