Parkinson DiseasePD_PalNCT05954013
Advance Care Planning and Care Coordination for People With Parkinson's Disease
A study testing PD_Pal intervention in people with Parkinson Disease and Parkinsonism, run by Radboud University Medical Center at 7 sites in 7 countries.
Trial summary
Background: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinsonism
- What is being tested?
- PD_Pal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 6 Aug 2020to 17 Mar 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Capable to participate , meaning that the subject is able to:
- understand information about the decision
- remember that information
- use that information to make a decision
- communicate their decision by talking, using sign language or any other means
- Able to provide informed consent;
Show all 15Show fewer
- Meeting the MDS clinical diagnostic criteria for PD, including Parkinsonisms;
- Hoehn \& Yahr ≥ 3;
- Progressive deterioration in physical and/or cognitive function despite optimal therapy, according to the primary physician; and
- Availability of a family caregiver or informal caregiver.
- Identified by the patient as the person closest to them;
- Willing to provide written informed consent;
- Willing and able to complete questionnaires;
- Aging ≥ 18 years.
- FC can only participate when the patient participates.
Who cannot join
- Inability to communicate independently, with or without supportive communication tools; - Unable or unwilling to commit to study procedures;
- Presence of additional chronic medical illnesses which may require palliative services (e.g. metastatic cancer);
- Already receiving palliative care or hospice services;
- Already participating in a clinical study for palliative care.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Evaluating the Clinical and Cost-effectiveness of a Combined Person-centred Intervention of Advance Care Planning (ACP) and Care Coordination for People With Parkinson's Disease and Their Family Caregiver(s)
Background: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and serves to ensure that people receive treatment and care that is in line with their preferences during serious chronic illness. The effectiveness of ACP for PD is currently unknown.
Methods: The investigators will evaluate the effectiveness of a multicenter, open-label randomized controlled trial, with a parallel group design in seven European countries (Austria, Estonia, Germany, Greece, Italy, Sweden and United Kingdom). The "PD_Pal intervention" comprises (1) several consultations with a trained nurse who will perform ACP conversations and support care coordination and (2) use of a patient-directed "Parkinson Support Plan-workbook". The intervention group will be compared to a care-as-usual group. Documented ACP-decisions in the medical records/patient's central file assessed at 6 months after baseline will be the primary endpoint. Secondary endpoints include patients' and family caregivers' quality of life, perceived care coordination, patients' symptom burden, and cost-effectiveness. Assessments will take place at baseline, 6 months after baseline and 12 months after baseline. In parallel, we will perform a process evaluation, to understand the feasibility of the intervention.
Hypothesis: The investigators hypothesize that the PD_Pal intervention will result in an increased number of participants with ACP documentation in the medical records/patient's central file, as compared to care-as-usual. Secondly, the investigators expect that, due to the PD_Pal intervention, patients and their FC will experience better care coordination, better quality of life, a reduced patient symptom burden and the FC will experience a reduction in caregiver burden.
- Conditions
- Parkinson Disease, Parkinsonism
- Being tested
- PD_Pal intervention
- Keywords
- Advance Care Planning
- 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.
PD_Pal interventionBehavioural
The PD_Pal intervention will be delivered by a nurse that is specifically trained to deliver the PD_Pal intervention, i.e. the PD_Pal nurse. In the PD_Pal intervention, the patient, family caregiver and PD_Pal nurse complete four steps wherein they discuss and compose a: 1) Individual care plan; 2) Proactive care plan; 3) Quality of life and end-of-life plan and; 4) Coordination and revision plan. Together these steps lead to the Parkinson Support Plan. To facilitate patients in taking these steps, all patients receive a Parkinson Support Plan workbook. This workbook consists of information and questions aligned with the four steps. Patients can utilize this workbook before, during, or after the conversations with the PD_Pal nurse.
| Study group | Role | What they receive |
|---|---|---|
| PD_Pal intervention | Experimental | Participants with Parkinson's disease receive usual care from their established neurology and/or home care team + the PD_Pal intervention. Receives: Behavioral: PD_Pal intervention |
| Control group | No intervention | Participants with Parkinson's disease receive usual care from their established neurology and/or home care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance care planning documentation in the medical records
Percentage of participants with documented advance care planning (ACP) preferences and wishes in the medical records at 6 months. Only participants who did not have documented ACP at baseline are included in this calculation.
Measured: 6 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).
Secondary outcomes (15)
Advance care planning documentation in the medical records
Percentage of participants with documented advance care planning (ACP) preferences and wishes in the medical records at 12 months. Only participants who did not have documented ACP at baseline are included in the calculation.
Measured: 12 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).
Integrated Palliative Care Outcome Scale (IPOS)
Change from baseline in palliative phase symptom severity
Measured: 6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse
Edmonton Symptom Assessment Scale for Parkinson's Disease (ESAS-PD)
Change from baseline in disease specific symptoms
Measured: 6 months after baseline; ESAS-PD score range = 0-140; higher scores are worse
Beck Depression Inventory (BDI-I)
Change from baseline in depression severity
Measured: 6 months after baseline; BDI-I score range = 0-63; higher scores are worse
Parkinson's Disease Questionnaire-39 (PDQ-39)
Change from baseline in quality of life
Measured: 6 and 12 months after baseline; PDQ-39 score range = 0-100; higher scores are worse
EQ-5D-5L (patient)
Change from baseline in self-rated health status in 5 domains
Measured: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse
Self-rated health status (patient), on a 0-100 point VAS scale
Change from baseline in self-rated health status
Measured: 6 and 12 months after baseline; score range: 0-100; higher scores indicated better self-rated health status
EQ-5D-5L (family caregiver)
Change from baseline of caregiver's health status in 5 domains
Measured: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse
Quality of life questionnaire for carers - PQoL Carer
Change from baseline in burden experienced by family caregiver
Measured: 6 and 12 months after baseline; PQoL Carer score range = 0-100; higher scores are worse
Modified Nijmegen Continuity Questionnaire (mNCQ)
Change from baseline in perceived care coordination
Measured: 6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse
Short Assessment of Patient Satisfaction (SAPS)
Change from baseline in quality of care
Measured: 6 months after baseline; SAPS score range = 0-32; higher scores are worse
Experienced involvement in decision making (CollaboRATE)
Change from baseline in experienced involvement in decision making.
Measured: 6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse
MDS Non-Motor Rating Scale (MDS-NMS)
Change from baseline in non-motor symptom severity
Measured: 6 and 12 months after baseline; MDS-MMS score range = 0-832; higher scores are worse
Quality of Dying and Death questionnaire (QoDD), if applicable
Quality of the dying process, experienced by family caregiver
Measured: 30 days after death of patient; QoDD score range = 0-100; lower scores are worse
Resource Utilization questionnaire (RUD) adapted for PD
Change from baseline in resource utilisation
Measured: 6 and 12 months after baseline; RUD score range not applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start6 Aug 2020
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, University of Ioannina, University College, London, Estonian Movement Disorders Society, Paracelsus Medical University, Philipps University Marburg, Skane University Hospital, Mediolanum Cardio Research
- Responsible party
- Sponsor
- Investigators
- Angelo Antonini, MD, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954013
- Sponsor's protocol ID
- 108177
- Other IDs
- NL8180
- Acronym
- PD_Pal
- Status last verified
- Aug 2022
- First submitted
- 25 May 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dijkstra BW, Muente C, Garon M, Rosqvist K, Scharfenort M, Lex KM, Poku P, Nixina E, Taba P, Krikmann U, Sikk K, Flanagan K, Schrag AE, Konitsiotis S, Makrydimas M, Lorenzl S, Odin P, Pedrosa DJ, Vissers KCP, Groot MM, Bloem BR, Meinders MJ, Antonini A; PD_Pal consortium. Documented End-of-Life Preferences of People With Parkinson's Disease or Parkinsonism Across Europe. Mov Disord Clin Pract. 2026 May;13(5):1217-1227. doi: 10.1002/mdc3.70467. Epub 2025 Dec 3.
PubMed 41334626
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical and Cost-effectiveness of a Combined Person-centred Intervention of Advance Care Planning (ACP) and Care Coordination for People With Parkinson's Disease and Their Family Caregiver(s)
- ClinicalTrials.gov ID
- NCT05954013
- Acronym / sponsor ID
- PD_Pal / 108177
- Conditions
- Parkinson Disease, Parkinsonism
- Keywords
- Advance Care Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- University of Padova, University of Ioannina, University College, London, Estonian Movement Disorders Society, Paracelsus Medical University, Philipps University Marburg, Skane University Hospital, Mediolanum Cardio Research
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 20 Jul 2023 (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.
Background: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and serves to ensure that people receive treatment and care that is in line with their preferences during serious chronic illness. The effectiveness of ACP for PD is currently unknown.
Methods: The investigators will evaluate the effectiveness of a multicenter, open-label randomized controlled trial, with a parallel group design in seven European countries (Austria, Estonia, Germany, Greece, Italy, Sweden and United Kingdom). The "PD_Pal intervention" comprises (1) several consultations with a trained nurse who will perform ACP conversations and support care coordination and (2) use of a patient-directed "Parkinson Support Plan-workbook". The intervention group will be compared to a care-as-usual group. Documented ACP-decisions in the medical records/patient's central file assessed at 6 months after baseline will be the primary endpoint. Secondary endpoints include patients' and family caregivers' quality of life, perceived care coordination, patients' symptom burden, and cost-effectiveness. Assessments will take place at baseline, 6 months after baseline and 12 months after baseline. In parallel, we will perform a process evaluation, to understand the feasibility of the intervention.
Hypothesis: The investigators hypothesize that the PD_Pal intervention will result in an increased number of participants with ACP documentation in the medical records/patient's central file, as compared to care-as-usual. Secondly, the investigators expect that, due to the PD_Pal intervention, patients and their FC will experience better care coordination, better quality of life, a reduced patient symptom burden and the FC will experience a reduction in caregiver burden.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD_Pal intervention | Experimental | Behavioral: PD_Pal interventionParticipants with Parkinson's disease receive usual care from their established neurology and/or home care team + the PD_Pal intervention. |
| Control group | No intervention | –Participants with Parkinson's disease receive usual care from their established neurology and/or home care team. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Capable to participate , meaning that the subject is able to:
- Able to provide informed consent;
- Meeting the MDS clinical diagnostic criteria for PD, including Parkinsonisms;
- Hoehn \& Yahr ≥ 3;
- Progressive deterioration in physical and/or cognitive function despite optimal therapy, according to the primary physician; and
Key exclusion criteria (4 listed)
- Inability to communicate independently, with or without supportive communication tools; - Unable or unwilling to commit to study procedures;
- Presence of additional chronic medical illnesses which may require palliative services (e.g. metastatic cancer);
- Already receiving palliative care or hospice services;
- Already participating in a clinical study for palliative care.
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 |
|---|---|---|
| PD_Pal interventionThe PD_Pal intervention will be delivered by a nurse that is specifically trained to deliver the PD_Pal intervention, i.e. the PD_Pal nurse. In the PD_Pal intervention, the patient, family caregiver and PD_Pal nurse complete four steps wherein they discuss and compose a: 1) Individual care plan; 2) Proactive care plan; 3) Quality of life and end-of-life plan and; 4) Coordination and revision plan. Together these steps lead to the Parkinson Support Plan. To facilitate patients in taking these steps, all patients receive a Parkinson Support Plan workbook. This workbook consists of information and questions aligned with the four steps. Patients can utilize this workbook before, during, or after the conversations with the PD_Pal nurse. | Behavioural | PD_Pal intervention |
Primary outcome
Advance care planning documentation in the medical records
Time frame: 6 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).
Percentage of participants with documented advance care planning (ACP) preferences and wishes in the medical records at 6 months. Only participants who did not have documented ACP at baseline are included in this calculation.
15 secondary outcomes
Advance care planning documentation in the medical records
Time frame: 12 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).
Integrated Palliative Care Outcome Scale (IPOS)
Time frame: 6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse
Edmonton Symptom Assessment Scale for Parkinson's Disease (ESAS-PD)
Time frame: 6 months after baseline; ESAS-PD score range = 0-140; higher scores are worse
Beck Depression Inventory (BDI-I)
Time frame: 6 months after baseline; BDI-I score range = 0-63; higher scores are worse
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: 6 and 12 months after baseline; PDQ-39 score range = 0-100; higher scores are worse
EQ-5D-5L (patient)
Time frame: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse
Self-rated health status (patient), on a 0-100 point VAS scale
Time frame: 6 and 12 months after baseline; score range: 0-100; higher scores indicated better self-rated health status
EQ-5D-5L (family caregiver)
Time frame: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse
Quality of life questionnaire for carers - PQoL Carer
Time frame: 6 and 12 months after baseline; PQoL Carer score range = 0-100; higher scores are worse
Modified Nijmegen Continuity Questionnaire (mNCQ)
Time frame: 6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse
Short Assessment of Patient Satisfaction (SAPS)
Time frame: 6 months after baseline; SAPS score range = 0-32; higher scores are worse
Experienced involvement in decision making (CollaboRATE)
Time frame: 6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse
MDS Non-Motor Rating Scale (MDS-NMS)
Time frame: 6 and 12 months after baseline; MDS-MMS score range = 0-832; higher scores are worse
Quality of Dying and Death questionnaire (QoDD), if applicable
Time frame: 30 days after death of patient; QoDD score range = 0-100; lower scores are worse
Resource Utilization questionnaire (RUD) adapted for PD
Time frame: 6 and 12 months after baseline; RUD score range not applicable
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 14 Aug 2026.
- Results publication: PubMed 41334626Dijkstra BW, Muente C, Garon M, Rosqvist K, Scharfenort M, Lex KM, Poku P, Nixina E, Taba P, Krikmann U, Sikk K, Flanagan K, Schrag AE, Konitsiotis S, Makrydimas M, Lorenzl S, Odin P, Pedrosa DJ, Vissers KCP, Groot MM, Bloem BR, Meinders MJ, Antonini A; PD_Pal consortium. Documented End-of-Life Preferences of People With Parkinson's Disease or Parkinsonism Across Europe. Mov Disord Clin Pract. 2026 May;13(5):1217-1227. doi: 10.1002/mdc3.70467. Epub 2025 Dec 3.
- 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.
Angelo Antonini, MD, PhD principal investigator
University of Padova
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD_Pal intervention in people with Parkinson Disease and Parkinsonism, run by Radboud University Medical Center at 7 sites in 7 countries.
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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Estonia, Germany, Greece, Italy and 2 more countries. 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?
Advance care planning documentation in the medical records (time frame: 6 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05954013, which also lists 1 linked publication.
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 14 Aug 2026.