Parkinson's Disease and ParkinsonismACT for PDNCT05599659
The Calgary Movement Disorders Advanced Care Pilot Program
A study testing Palliative care in people with Parkinson's Disease and Parkinsonism, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Parkinson's Disease and Parkinsonism
- What is being tested?
- Palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2022to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Movement Disorder Program, Foothills Medical Center, Alberta Health Services
Calgary, Alberta, T2N 4N1
Veronica Bruno, MD, MPH, 4032207875, veronica.bruno@ucalgary.ca
Karla Cantu Flores, MD
About this study
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.
- Conditions
- Parkinson's Disease and Parkinsonism
- Being tested
- Palliative care
- Keywords
- Palliative Care
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative careBehavioural
Also called Advanced 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.
| Study group | Role | What they receive |
|---|---|---|
| Palliative care | Experimental | Participants will receive palliative care. Receives: Behavioral: Palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Every 3 months for 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start4 Nov 2022 (estimated)
- Primary completion4 Nov 2024 (estimated)
- Study completion4 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease and ParkinsonismStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Bruno, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599659
- Sponsor's protocol ID
- REB22-0545
- Acronym
- ACT for PD
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Calgary Movement Disorders Advanced Care Pilot Program
- ClinicalTrials.gov ID
- NCT05599659
- Acronym / sponsor ID
- ACT for PD / REB22-0545
- Conditions
- Parkinson's Disease and Parkinsonism
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 4 Nov 2022 (estimated)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 4 Nov 2024 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Palliative care | Experimental | Behavioral: Palliative careParticipants will receive palliative care. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative careAlso: Advanced careIt 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. | Behavioural | Palliative care |
Primary outcome
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.
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.
3 secondary outcomes
Changes in Edmonton Symptom Assessment Scale revised for Parkinson's Disease (ESAS-PD)
Time frame: Every 3 months for 2 years
Changes in the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp-12)
Time frame: Every 3 months for 2 years
Semi-structured Qualitative Interview to receive Patient and Care Partner recommendations
Time frame: Every 3 months for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative care in people with Parkinson's Disease and Parkinsonism, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronica Bruno, MD, MPH (4039194262, veronica.bruno@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of Life Alzheimer's Disease (QOL-AD) (time frame: Every 3 months for 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.