Quality-of-Life Index (Q-Index)

NCT06209502 | Unknown

• 1 other identifier: KC-QI-2023
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Smartwatch; Smartphone; Quality of life; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Primary objective

  Primarily, this longitudinal study targets patients with Parkinson's Disease between the stages of one-and-a-half (1.5) and three (3) in the Hoehn \& Yahr scale (in the context of this study; population A). By considering the aforementioned population, the primary objective is to build an algorithm towards the remote assessment of the individuals' Health-related QoL (HrQoL). This is to be achieved by formulating and estimating the Quality-of-Life index (Q-index) based on continuously and passively recorded data from commercially available wearable and portable technology (i.e., an Android smartwatch and an Android smartphone).

  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 (1)

• Secondary objective

  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 (2)

• Exploratory objective 1

  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.

• Exploratory objective 2

  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.

Study Arms (3)

Population A

Parkinson's disease patients between H\&Y stages 1.5 and 3

Population B

Early Parkinson's disease patients of H\&Y stage 1

Population C

Healthy controls

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koios Care: lead

Study Sites (1)

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Gaetan Garraux

CONTACT

+32 498 18 33 44; ggarraux@uliege.be

Konstantinos Kyritsis

CONTACT

+32 472 68 44 28; konstantinos.kyritsis@koios.care

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 17, 2024
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)