Using smart devices to monitor quality of life in Parkinson's disease
Q-Index: A Proof of Concept Investigation Towards Monitoring the Health-related Quality of Life of Parkinson's Disease Patients Using Wearable and Portable Devices.
This study is testing if using smartphones and smartwatches can help track the quality of life for people with Parkinson's disease over nine months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Koios Care Industry-sponsored |
| Locations | 1 site (Roeselare) |
| Trial ID | NCT06209502 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize smartphones and smartwatches to remotely assess and monitor the health-related quality of life (HrQoL) of individuals with Parkinson's disease at various stages. The study will involve up to 100 patients with moderate Parkinson's disease, 15 patients in early stages, and 15 healthy controls over a duration of approximately 9 months. Participants will use the Koios Care application on their Android devices to collect data, which will help formulate a quality of life index (Q-index) based on passive data recording. The study will include clinical assessments at baseline and follow-ups to evaluate the sensitivity of the Q-index in monitoring quality of life.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 30 to 75 diagnosed with idiopathic Parkinson's disease at specific stages of progression.
Not a fit: Patients who are unable to comprehend French or Dutch or those with other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel method for continuously monitoring and improving the quality of life for patients with Parkinson's disease.
How similar studies have performed: While the use of wearable devices for health monitoring is gaining traction, this specific approach to assessing quality of life in Parkinson's disease is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females between the ages of 30 and 75 * Agree to download and install the Koios Care application to their personal Android smartphone. * People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease. o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met. * Score between one-and-a-half (1.5) and three (3) at the H\&Y rating scale in the "ON" state (population A) * Score of one (1) at the H\&Y rating scale in the "ON" state (population B) Exclusion Criteria: * The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level. * The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities). * The candidate is not an Android smartphone owner and user for at least six (6) months. * The candidate's Android smartphone is not compatible with the Koios Care application. * The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24. * The candidate has exhibited uncontrolled/extreme measures of depression as judged by the expert investigator, e.g., self-harm, suicide attempts or patient admitted to the hospital for a similar reason. -- If the participant develops such behavior or s/he is admitted to the hospital for the above reasons during the study, then the candidate is immediately removed from the study. * Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Where this trial is running
Roeselare
- AZ Delta — Roeselare, Belgium (Recruiting)
Study contacts
- Study coordinator: Gaetan Garraux
- Email: ggarraux@uliege.be
- Phone: +32 498 18 33 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.