Skip to main content
OpenTrials
Completed

NCT Number: NCT05954013

Advance Care Planning and Care Coordination for People With Parkinson's Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Parkinsonism Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paracelsus Medical University, Salzburg, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for people with Parkinson's disease:

  • 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;
  • 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.

Exclusion criteria

  • 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.

Inclusion criteria

for family caregivers (FCs):

  • 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.

Treatment and study plan

PD_Pal intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

    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.

  2. Integrated Palliative Care Outcome Scale (IPOS)

    Time frame: 6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse

    Change from baseline in palliative phase symptom severity

  3. 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

    Change from baseline in disease specific symptoms

  4. Beck Depression Inventory (BDI-I)

    Time frame: 6 months after baseline; BDI-I score range = 0-63; higher scores are worse

    Change from baseline in depression severity

  5. 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

    Change from baseline in quality of life

  6. EQ-5D-5L (patient)

    Time frame: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse

    Change from baseline in self-rated health status in 5 domains

  7. 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

    Change from baseline in self-rated health status

  8. EQ-5D-5L (family caregiver)

    Time frame: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse

    Change from baseline of caregiver's health status in 5 domains

  9. 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

    Change from baseline in burden experienced by family caregiver

  10. Modified Nijmegen Continuity Questionnaire (mNCQ)

    Time frame: 6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse

    Change from baseline in perceived care coordination

  11. Short Assessment of Patient Satisfaction (SAPS)

    Time frame: 6 months after baseline; SAPS score range = 0-32; higher scores are worse

    Change from baseline in quality of care

  12. Experienced involvement in decision making (CollaboRATE)

    Time frame: 6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse

    Change from baseline in experienced involvement in decision making.

  13. 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

    Change from baseline in non-motor symptom severity

  14. 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

    Quality of the dying process, experienced by family caregiver

  15. Resource Utilization questionnaire (RUD) adapted for PD

    Time frame: 6 and 12 months after baseline; RUD score range not applicable

    Change from baseline in resource utilisation

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Estonian Movement Disorders Society
  • Mediolanum Cardio Research
  • Paracelsus Medical University
  • Philipps University Marburg
  • Skane University Hospital
  • University College, London
  • University of Ioannina
  • University of Padova

Registry information

Official study 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)

Acronym: PD_Pal

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.