Parkinson DiseasePalliate-PDNCT03697434
Acceptability of Palliative Care in Parkinson Disease Care
A study testing Palliative Care referral in people with Parkinson Disease, run by University of Rochester at 1 site in United States.
Trial summary
This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Palliative Care referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 2 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider
- 18 years of age or older
- Participant or care partner able to provide informed consent
- Presence of one or more of the following:
- Uncontrolled symptoms (over prior week):
- Depression
Show all 15Show fewer
- Pain
- Fatigue
- Critical events (over prior 6 months):
- ≥3 falls
- Unintended weight loss
- Wheelchair dependence (>50% of time)
- Care partner of enrolled participant in the study
- 18 years of age or older
- Able to provide informed consent
Who cannot join
- Diagnosis of atypical or secondary parkinsonism
- Outpatient palliative care visit scheduled or within the prior 6 months of the screening visit
- Subjects who are care partners:
- No care partner specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
URMC Neurology; 919 Westfall Rd, Building C
Rochester, New York, 14618
About this study
Official title: Pilot to Assess the Acceptance of Palliative Care Referral Among Those With Parkinson Disease
This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.
- Conditions
- Parkinson Disease
- Being tested
- Palliative Care referral
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care referralBehavioural
Individuals with Parkinson disease identified as having specific uncontrolled symptoms or critical events will undergo standardized referral to palliative care, who will provide supportive care. During the palliative care referral, participants and their care partners may discuss symptoms, disease burden (physical, emotion, financial, and psychological), quality of life, goals of care, and advance directive completion. Palliative care specialists may recommend interventions to manage bothersome symptoms or to improve disease burden for both participants and care partners.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care referral | Experimental | Participants with specific uncontrolled symptoms or critical events in course of their Parkinson disease will be referred to a palliative care specialist for supportive care. Receives: Behavioral: Palliative Care referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral
We will assess the feasibility of standardized referral to palliative care by calculating the proportion of enrolled participants with Parkinson disease who have at least 1 visit with a palliative care provider within 3 months of referral.
Measured: 3 months
Secondary outcomes (6)
Change in mean symptom burden
Symptom burden will be measured using the Edmonton Symptom Assessment Scale-Revised for Parkinson Disease (ESAS-R: PD), which measures the severity of 14 symptoms on a 1-10 scale. Scores range from 0-140 with higher scores indicating higher symptom burden.
Measured: Baseline to 3 months
Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)
Quality of life will be measured using the Quality of Life-Alzheimer Disease questionnaire, which is a 13-item measure that assesses overall quality of life with a focus on physical, social, psychological, and spiritual well-being. Scores range from 13-52 with higher scores indicating better quality of life.
Measured: Baseline to 3 months
Change in mean caregiver burden
Caregiver burden will be measured using the Zarit Burden interview, which is a 22-item questionnaire that assesses caregiver fear, anger, guilt, perspective, hope, and overall quality of life. Scores range from 0-88 with a score of 0-21 associated with little or no burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and 61-88 severe burden.
Measured: Baseline to 3 months
Change in mean caregiver self-efficacy
Caregiver self-efficacy will be measured using the Revised Scale for Caregiver Self-efficacy, which is a 15-item questionnaire with 3 sub-sections (self-efficacy for obtaining respite, self-efficacy for responding to disruptive patient behaviors, and self-efficacy for controlling upsetting thoughts about caregiving). Respondents rate their certainty of being able to complete each task from 0% (cannot perform task at all) to 100% (certain that task can be performed). Scores on each of the sub-sections range from 0-500 with a higher score indicating greater self-efficacy.
Measured: Baseline to 3 months
Barriers to palliative care referral
Barriers to palliative care referral will be measured using a novel qualitative survey that assesses perceived barriers to referral and drivers of desire for referral to palliative care among those with Parkinson disease. The measure includes a qualitative survey of 9 potential barriers to consultation and 5 potential reasons to undergo consultation. Respondents can select as many barriers or reasons as applicable to their perception of referral and can provide free text responses. Overall frequency of selection of each identified barrier among participants will be assessed both at baseline and at 3 months following palliative care referral. Barriers and reasons for referral with higher frequency will be considered to be more important in hindering or driving desire for referral, respectively.
Measured: Baseline
Barriers to palliative care referral
Barriers to palliative care referral will be measured using a novel qualitative survey that assesses perceived barriers to referral and drivers of desire for referral to palliative care among those with Parkinson disease. The measure includes a qualitative survey of 9 potential barriers to consultation and 5 potential reasons to undergo consultation. Respondents can select as many barriers or reasons as applicable to their perception of referral and can provide free text responses. Overall frequency of selection of each identified barrier among participants will be assessed both at baseline and at 3 months following palliative care referral. Barriers and reasons for referral with higher frequency will be considered to be more important in hindering or driving desire for referral, respectively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start16 Nov 2018
- Primary completion1 Jun 2019
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Neurology
- Responsible party
- Principal investigator, Christopher Tarolli, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697434
- Sponsor's protocol ID
- 72429
- Acronym
- Palliate-PD
- Status last verified
- Dec 2019
- First submitted
- 3 Oct 2018
- Last updated
- 9 Dec 2019
- Results posted
- 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 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot to Assess the Acceptance of Palliative Care Referral Among Those With Parkinson Disease
- ClinicalTrials.gov ID
- NCT03697434
- Acronym / sponsor ID
- Palliate-PD / 72429
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Academy of Neurology
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 5 Oct 2018 (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.
This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative Care referral | Experimental | Behavioral: Palliative Care referralParticipants with specific uncontrolled symptoms or critical events in course of their Parkinson disease will be referred to a palliative care specialist for supportive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider
- 18 years of age or older
- Participant or care partner able to provide informed consent
- Presence of one or more of the following:
- Depression
Key exclusion criteria (4 listed)
- Diagnosis of atypical or secondary parkinsonism
- Outpatient palliative care visit scheduled or within the prior 6 months of the screening visit
- No care partner specific exclusion criteria
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 Care referralIndividuals with Parkinson disease identified as having specific uncontrolled symptoms or critical events will undergo standardized referral to palliative care, who will provide supportive care. During the palliative care referral, participants and their care partners may discuss symptoms, disease burden (physical, emotion, financial, and psychological), quality of life, goals of care, and advance directive completion. Palliative care specialists may recommend interventions to manage bothersome symptoms or to improve disease burden for both participants and care partners. | Behavioural | Palliative Care referral |
Primary outcome
Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral
Time frame: 3 months
We will assess the feasibility of standardized referral to palliative care by calculating the proportion of enrolled participants with Parkinson disease who have at least 1 visit with a palliative care provider within 3 months of referral.
6 secondary outcomes
Change in mean symptom burden
Time frame: Baseline to 3 months
Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)
Time frame: Baseline to 3 months
Change in mean caregiver burden
Time frame: Baseline to 3 months
Change in mean caregiver self-efficacy
Time frame: Baseline to 3 months
Barriers to palliative care referral
Time frame: Baseline
Barriers to palliative care referral
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 referral in people with Parkinson Disease, run by University of Rochester at 1 site in United States.
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 15 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: finished, as of the sponsor's last update on 9 Dec 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral (time frame: 3 months). 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 9 Dec 2019.