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Parkinson DiseaseAUTAPNCT05405998

Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy (AUTAP)

A study testing Proactive care pathway in people with Parkinson Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Continuous subcutaneous apomorphine infusion (CSAI) has proven to be effective in advaced Parkinson's disease patients with motor fluctuations not controlled by oral or transdermal medication. After initiation of this therapy, most of the patients need nurse services at home for the entire duration of treatment. 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?
Proactive care pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
1 Dec 2022to Jul 2025
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

  • Patient of legal age;
  • Affiliated to the social security;
  • Parkinson's disease according to the diagnostic criteria of the UK Parkinson's disease society brain bank clinical diagnostic criteria;
  • Presence of disabling motor fluctuations and/or dyskinesia despite optimized oral treatment (MDS-UPDRS IV item >2)
  • Patient eligible for and accepting apomorphine pump therapy
  • Autonomous patient (Hoehn and Yahr stage < 4);
Show all 9Show fewer
  • No significant cognitive impairment (MoCA >= 25)
  • Patient can be autonomous on the daily management of the pump according to the investigator's opinion.
  • Patient having signed an informed consent

Who cannot join

  • Significant cognitive impairment (MoCA score <25);
  • Major depressive episode, uncontrolled at the time of assessment (BDI>25) or bipolar disorder;
  • Active visual hallucinations or history of severe hallucination episodes;
  • Previous apomorphine pump use;
  • History of respiratory distress;
  • History of severe impulse control disorders;
  • Patient and/or caregiver who cannot be empowered in the opinion of the investigator.
  • Protected persons, curators, persons under court protection, persons deprived of liberty by judicial or administrative decision, persons under forced psychiatric care and persons admitted to a health or social institution for purposes other than those of the research

Trial locations and contacts

1 site in 1 country.

Guillaume HACHE contact

(0)4 91 38 43 98

guillaume.hache@ap-hm.fr

Claire MORANDO contact

0(4) 91 38 21 83

claire.morando@ap-hm.fr

France1 site, 1 recruiting

  • AP-HM

    Marseille

    Guillaume HACHE

    Recruiting

Other trials in France

About this study

Official title: Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy

Continuous subcutaneous apomorphine infusion (CSAI) has proven to be effective in advaced Parkinson's disease patients with motor fluctuations not controlled by oral or transdermal medication. After initiation of this therapy, most of the patients need nurse services at home for the entire duration of treatment. Some patients are reluctant about this dependence and thus may refuse or delay the initiation of CSAI. To date, there is no guideline to promote patients' autonomy in managing CSAI treatment. Thus we developed a program focusing on early autonomy during CSAI intitiation, through empowering the patient or their carer, and promoting primary and tertiary care.

The hypothesis is that implementing the program will lead patients to autonomy. This will have beneficial effects on clinical and heath-related outcomes and may be cost-effective.

Read the detailed description

The main objective of the project is to evaluate the impact of the proactive care pathway during the installation of an apomorphine pump on the autonomy at 6 months of patients with Parkinson's disease at the stage of motor complications.

This care pathway corresponds to a care program combining therapeutic education of the patient, modification of the hospital course and city-hospital coordination. The content of this program is detailed below in chapter III.3. Experimental group: proactive care pathway.

The interest of the protocol will be evaluated at several levels: from the patients' point of view, from the caregivers' point of view, from the medico-economic point of view. Among all the indicators, the achievement of autonomy is retained as the main criterion (see chapter on main evaluation criterion).

Secondary objectives are to measure the value of the proactive care pathway on:

  • Patient-related parameters Psychobehavioral factors (quality of life, self-esteem, mood...) ; Treatment persistence; Patient satisfaction; Clinical symptomatology (overall clinical impression, motor and non-motor symptoms, impulse control disorders).
  • Caregiver burden.
  • Use of the care system in both groups and medico-economic impact of the intervention (cost-consequence analysis and cost-utility analysis) from a societal perspective;

For this study, patients will be accompanied by their caregivers.

Being tested
Proactive care pathway
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive care pathwayOther

    Patient participation in a specific therapeutic education program, as soon as the therapeutic decision is made.

    The reinforced cooperation of the expert centers with the homecare providers on 2 different times:

    1. before the installation of the pump, i.e. before the episode of hospitalization dedicated to the starting of the treatment;
    2. after the installation of the pump following the above mentioned hospitalization.
Study groups in NCT05405998
Study groupRoleWhat they receive
Experimental group : proactive courseExperimentalThe strategy is based on the implementation of an "optimized" proactive care pathway, combining elements that promote city-hospital coordination in setting up the pump and elements that promote patient education.
Receives: Other: Proactive care pathway
Control group : optimized medical treatmentNo interventionAt the end of the inclusion visit (see previous chapter), the patient will be invited to come to the hospital two weeks later for pump placement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of autonomy

    The patient will be considered autonomous if he/she does not need nursing care to manage his/her treatment and the pump for 15 days

    Measured: 6 months

  2. Unified Parkinson's disease rating scale (MDS-UPDRS), section VI (Schwab and England)

    Gold standard in the evaluation of activity in daily living in PD patients. The score varies per question from 0 to 4. If the patient scores 0, it means that he/she does not have any particular problem related to the disease. On the contrary, if the patient obtains a score of 4 for a question, it means that the disease has a severe impact on his daily life.

    Measured: 6 months

Secondary outcomes (7)

  1. Parkinson disease questionnaire 39 (PDQ39)

    Self-assessment questionnaire integrating 39 items evaluating quality of life of PD patients. Establish a score between 0 and 100.

    Measured: 6 months and 12 months

  2. MDS-UPDRS section II

    This section evaluate the motor aspects of experiences in daily living. The score varies per question from 0 to 4. If the patient scores 0, it means that he/she does not have any particular problem related to the disease. On the contrary, if the patient obtains a score of 4 for a question, it means that the disease has a severe impact on his daily life.

    Measured: 6 months and 12 months

  3. MDS-UPDRS section I

    This section evaluate the non-motor aspects of experiences of daily living.The score varies per question from 0 to 4. If the patient scores 0, it means that he/she does not have any particular problem related to the disease. On the contrary, if the patient obtains a score of 4 for a question, it means that the disease has a severe impact on his daily life.

    Measured: 6 months and 12 months

  4. Clinical Global impression

    Measured by the patient, the caregiver and the investigator. There are 2 components to the CGI (20): (i) the CGI-severity to assign a disease severity score from 1 to 7 (1=no disease; 7=very severe). (ii) the CGI-Improvement which establishes a score of improvement since the beginning of treatment between 1 and 7 (1=great improvement; 7=great deterioration)

    Measured: 6 months and 12 months

  5. MDS-UPDRS III and IV

    This section evaluate the motor examination (III) and motor complications (IV).The score varies per question from 0 to 4. If the patient scores 0, it means that he/she does not have any particular problem related to the disease. On the contrary, if the patient obtains a score of 4 for a question, it means that the disease has a severe impact on his daily life.

    Measured: 6 months and 12 months

  6. QUIP RS

    Questionnaire for impulsive-compulsive disorders in Parkinson's disease-rating scale. The score per question varies from 0 to 4. If the patient obtains a 0, it means that he/she does not have an impulse control disorder. On the contrary, if the patient gets a 4 it means that he/she has an impulse control disorder very often. The total score of the questionnaire varies between 0 and 112.

    Measured: 6 months and 12 months

  7. ZARIT score

    Assessment of caregiver burden. The score varies between 0 and 88. Score < 20: mild "burden 21 < score < 40: mild to moderate "burden 41 < score < 60 : moderate to severe "burden 61 < score < 88 : severe "burden

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2022
  2. Study start1 Dec 2022
  3. Primary completionJan 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

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
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05405998
Sponsor's protocol ID
2021-A01424-37
Acronym
AUTAP
Status last verified
Jun 2023
First submitted
17 May 2022
Last updated
9 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Proactive care pathway in people with Parkinson Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

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 9 inclusion and 8 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 9 Jun 2023. 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 France. 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 Guillaume HACHE ((0)4 91 38 43 98, guillaume.hache@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of autonomy (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT05405998.

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 Jun 2023.

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