The Calgary Movement Disorders Advanced Care Pilot Program

Parkinson's Disease and Parkinsonism Clinical Trial

— ACT for PD  

Official title:

The Calgary Movement Disorders Advanced Care Pilot Program

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05599659
• Other study ID #: REB22-0545
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: November 4, 2024

Study information

• Verified date: October 2022
• Source: University of Calgary
• Contact: Veronica Bruno, MD, MPH
• Phone: 4039194262
• Email: veronica.bruno[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 4, 2024
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Movement Disorder Program, Foothills Medical Center, Alberta Health Services	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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