NCT05599659

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

October 12, 2022

Last Update Submit

October 28, 2022

Conditions

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Changes in Edmonton Symptom Assessment Scale revised for Parkinson's Disease (ESAS-PD)

    Every 3 months for 2 years

  • 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

Study Arms (1)

Palliative care

EXPERIMENTAL

Participants will receive palliative care.

Behavioral: Palliative care

Interventions

Palliative careBEHAVIORAL

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.

Also known as: Advanced care
Palliative care

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Veronica Bruno, MD, MPH

CONTACT

Karla Cantu Flores, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 31, 2022

Study Start

November 4, 2022

Primary Completion

November 4, 2024

Study Completion

November 4, 2024

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations