Quality-of-Life Index (Q-Index)

Parkinson Disease Clinical Trial

Official title: 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.

Status Recruiting

Clinical Trial Summary

The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.

Clinical Trial Description

The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.

The study takes place in hospitals in Belgium. The study populations are as follows: up to 100 patients between stages H&Y 1.5 and 3 (population A), up to 15 patients with early-stage Parkinson's disease H&Y 1 (population B), and up to 15 healthy controls (population C). The duration of the study is approximately 9 months, between September 2023 and November 2024, and will include a baseline clinical assessment (month 0), the first follow-up (month 4) and the second follow-up (month 8).

The main objective is to build an algorithm capable of remotely assessing the health-related quality of life (HrQoL) of patients belonging to population A. This objective will be achieved by formulating and estimating the quality of life index (Q-index) based on continuously and passively recorded data from commercially available wearable devices (an Android smartwatch and a smartphone). The secondary objective is to determine whether the Q index is sufficiently sensitive to monitor the quality of life of people who are in the early stages of the disease (population B). A group of healthy control subjects (population C) will be used to identify the range of Q index values corresponding to healthy and PD populations.

To achieve this objective, we will compare the information extracted from connected devices (micro-indicators) with the responses of participants to questionnaires and clinical tests aimed at evaluating PROMs (patient-related outcome measures). The list of data collected is included in the following table.

To calculate the Q index, we plan to use a combination of several micro-indicators, each acting as a surrogate for the subject's ability to effectively perform certain activities of daily living; communication, sleep, eating, sociability and physical independence. An example of a micro-indicator is Plate-to-Mouth1 (PtM), which measures the individual's eating behavior by estimating the time required to transfer a quantity of food ready to be consumed, from the plate to the mouth.

The ability to accurately monitor health-related quality of life (HrQoL) characteristics will be assessed initially by examining how each micro-indicator correlates with appropriate items from validated questionnaires such as the Health-Related Quality of Life Questionnaire. Parkinson's disease, called PDQ-39. For example, eating behavior (and more specifically Plate-to-Mouth) is associated with upper limb sluggishness and is linked to items 11, 12, 13, 14 and 16 of the PDQ-39. After assessing each micro-indicator, the combined ability of the Q index to monitor HrQoL as a whole will be realized by comparing it to scores and subscores from validated PROMs scales, such as the PDQ-39. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT06209502
• Study type: Observational
• Source: Koios Care
• Contact: Gaetan Garraux
• Phone: +32 498 18 33 44
• Email: ggarraux@uliege.be
• Status: Recruiting
• Start date: November 1, 2023
• Completion date: October 31, 2024