Clinical trial NCT06609681: Parkinson Disease: A Model of National Digital Interventions to Prevent or Slow a Rise of Non-Communicable
Official title: Flipping the Paradigm of Parkinson Disease: A Model of National Eat, Move, Sleep Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease, Idiopathic
Keywords: Thai Parkinson Screening. Registry.
Lead sponsor: Chulalongkorn Centre of Excellence for Parkinson's Disease and Related Disorders
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Thai Adult age more than 40year old or have family history of Parkinson's disease

Brief summary: According to Parkinson's Disease Medical Center of Excellence's project which was registered Parkinson's disease patients in 2008-2011, it was found that there were more than 60,000 people with Parkinson's disease in Thailand, approximately 1 over 3 of all elderly people.

It is estimated that the prevalence of Parkinson's disease is approximately 242.57 per 100,000 people of all elderly people, and it is likely to increase due to the current situation of Thailand which is entering aging society. The current diagnosis of Parkinson's disease still relies heavily on medical history and physical examination. The accuracy of diagnosing Parkinson's disease by neurologists is approximately 80 percent, especially when they have been following up consistently. Nonetheless, if they have Parkinson's disease in the early stages, the signs and symptoms will not be severe. Therefore, diagnostic accuracy will decrease around 40-50 percent, making it difficult to diagnose Parkinson's disease patients at an early stage and as a consequence, there still are many undiagnosed patients in 2022. Consequently, Parkinson's Disease Medical Center of Excellence is planning to establish this pilot research project to develop and analyze advanced data of the screening system for people at risk and precursor symptoms to Parkinson's disease, Chulalongkorn Hospital, Thai Red Cross Society. Dividing patients into 3 groups, those who have precursor symptoms, who are at risk of developing disease and Parkinson's disease patients, using the digital platform on mobile application that includes general information, health information, congenital diseases, regularly used medications, initial abnormal symptoms, various risk factors, writing and handwriting, pronunciation assessments, and get diagnosis from experts for referral in the public health system.

Detailed description: 1. Flipping the Paradigm of Parkinson's Disease: A Model of National 'Eat, Move, Sleep' Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
2. Principal Investigator: Roongroj Bhidayasiri
3. Study centers and Address: Chulalongkorn Center of Excellence for Parkinson's disease and related to movement disorder 1183 RAMA 4 Rd. Pathum wan, Bangkok 10330 and 76 provinces of Thailand.

The Screening of Parkinson's patients with digital technology and sensors and analyze with artificial intelligence the following information

1. Innovative prototype questionnaire. Screening of Parkinson's patients with digital technology.
2. Sound screening that can detect speech
3. Handwriting test by writing sentences and spiral circles.
4. Testing finger dexterity and alternating tap test
5. Tremor analysis
6. Gait analysis
7. Assessing your ability to get out of bed
8. Sleep quality
9. Sleep assessment by polysomnography test
10. Ability to smell

Eligibility criteria: Inclusion Criteria:

1. Thai Adult age more than 40 years old.
2. Family history with Parkinson's disease.

Exclusion Criteria:

1. Thai Adult age less than 40 years old

Primary outcomes:
measure: Digital platform system; Motor and non-motor symptom of Parkinson' s disease questionnaire, tremor and voice test
timeFrame: 1 year
Secondary outcomes:
measure: Age
timeFrame: 1 year
measure: Early Lifestyle interventions Eat Move Sleep
timeFrame: 1 year
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Chulalongkorn Center of Excellence for Parkinson's disease and related to movement disorder
state: Bangkok
Study officials:
affiliation: Chulalongkorn Centre of Excellence for Parkinson's Disease and Related Disorders
name: Professor Roongroj Bhidayasiri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: