A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Pat… (NCT05273957) | Clinical Trial Compass
UnknownNot Applicable
A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.
Italy121 participantsStarted 2021-03-29
Plain-language summary
The present multicenter randomized study investigates whether the management of patients with parkinsonism by a nurse specialist (case-manager) can significantly improve patients' quality of life over 12 months, compared to control patients managed with the standard-of-care process.
Participants will be evaluated with clinical scales testing quality of life, motor and non-motor symptoms, and the number of unscheduled hospital access throughout the course of the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Living in the Lombardy region (Northern Italy)
* Duration of Parkinson's disease, atypical or secondary parkinsonism ≥ 3 years
* Presence of at least (i) n=1 motor complication and/or (ii), n=2 non-motor symptoms, defined as follows:
(i) Motor complication:
* Motor fluctuations
* ≥ 2 Falls in the last 6 months
* Dysphagia
(ii) Non Motor symptoms
* Non-motor fluctuations
* ≥ 2 items of the non-motor symptoms scale with a score ≥ 2
Exclusion Criteria:
* Hoehn and Yahr Stage = 5 in the ON-medication condition
* Psychiatric comorbidity or other neurological chronic diseases that, in the opinion of the recruiting neurologist, could compromise the study participation.
* Patients on infusional therapies (continuous infusion of levodopa-carbidopa intestinal gel or Continuous Subcutaneous Apomorphine Infusion).
* Severe medical disease (liver or kidney failure, decompensated heart disease, neoplasms, coagulopathy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in total score of the Parkinson's Disease Questionnaire 39-items scale
Timeframe: baseline, week 52
Trial details
NCT IDNCT05273957
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta