Clinical trial NCT06209502: Quality-of-Life Index (Q-Index)
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Smartwatch
Smartphone
Quality of life
Parkinson's Disease
Lead sponsor: Koios Care
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruitment process for Parkinson's Disease patients begins during a consultation taking place in one of the three participating clinics. Specifically, a member of the medical team informs the patient about the ongoing study, including but not limited to, its goals, the technology, and the timeline of the study.

The recruitment of a Parkinson's Disease patient also appears as an opportunity to recruit healthy participants. Specifically, the study targets members of the close circle of the patient, i.e., age-matched friends and close family members. It should be noted that to avoid recruitment bias (e.g., the partner of the patient stays home to support their patient partner), the partner of the patient is left as the emergency (low recruitment rate for healthy controls) recruitment scenario. In addition, the recruitment procedure for healthy controls will be supported by wall posters in the hospital campus and web advertising.

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Primary objective
timeFrame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Secondary outcomes:
measure: Secondary objective
timeFrame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Other outcomes:
measure: Exploratory objective 1
timeFrame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
measure: Exploratory objective 2
timeFrame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
References: