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Clinical Trials/NCT05599659
NCT05599659
Not Yet Recruiting
N/A

The Calgary Movement Disorders Advanced Care Pilot Program

University of Calgary1 site in 1 country100 target enrollmentNovember 4, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease and Parkinsonism
Sponsor
University of Calgary
Enrollment
100
Locations
1
Primary Endpoint
Changes in 12-Item Zarit Burden Interview (ZBI-12)
Status
Not Yet Recruiting
Last Updated
3 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
November 4, 2022
End Date
November 4, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Veronica Bruno

MD, MPH

University of Calgary

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.

Outcomes

Primary Outcomes

Changes in 12-Item Zarit Burden Interview (ZBI-12)

Time Frame: Every 3 months for 2 years

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

Time Frame: Every 3 months for 2 years

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.

Changes in Quality of Life Alzheimer's Disease (QOL-AD)

Time Frame: Every 3 months for 2 years

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.

Secondary Outcomes

  • Changes in the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp-12)(Every 3 months for 2 years)
  • Semi-structured Qualitative Interview to receive Patient and Care Partner recommendations(Every 3 months for 2 years)
  • Changes in Edmonton Symptom Assessment Scale revised for Parkinson's Disease (ESAS-PD)(Every 3 months for 2 years)

Study Sites (1)

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