The Philippine Neurological Association One Database -Dementia (PNA1DB-Dem)

July 31, 2022 updated by: Philippine Neurological Association

Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)

This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia.

All patients seen at the training institution clinically diagnosed with MCI or dementia by their neurologists will be invited to participate in the study. The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool. Patients who withdraw participation verbally or in writing are excluded by the investigator from further participation. Withdrawal from the study will be properly documented, including date, time, and reason for withdrawal. Withdrawn subjects will not have their clinical data included in the database.

Collective data will be extracted, summarized, and analyzed every year with oversight provided by the Philippine Neurological Association (PNA). To be able to assess trends and changes over time, data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed by the PNA.

Study Type

Observational

Enrollment (Anticipated)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Philippines
      • Manila, Philippines, 1008
        • Recruiting
        • Jose R. Reyes Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Joseree Catindig
      • Manila, Philippines, 1008
        • Recruiting
        • University of Santo Tomas Hospiatl
        • Contact:
        • Principal Investigator:
          • Encarnita R Ampil, MD
      • Manila, Philippines
        • Recruiting
        • University of the East- Ramon Magsaysay Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Stephanie Badillo, MD
      • Manila, Philippines
        • Not yet recruiting
        • University of the Philippines - Philippine General Hospital
        • Contact:
          • Alvin Cenina, MD
        • Contact:
          • afcenina@up.edu.ph
        • Principal Investigator:
          • Alvin Cenina, MD
    • Baguio
      • Baguio City, Baguio, Philippines
        • Recruiting
        • Baguio General Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Debbie Liquete, MD
    • Cebu
      • Cebu City, Cebu, Philippines
        • Recruiting
        • Chong Hua Hospital
        • Contact:
        • Principal Investigator:
          • Virginia Espanol, MD
    • Metro Manila
      • Makati City, Metro Manila, Philippines
        • Recruiting
        • Makati Medical Center
        • Contact:
        • Principal Investigator:
          • Donnabelle Chu, MD
      • Pasig City, Metro Manila, Philippines
        • Not yet recruiting
        • The Medical City
        • Contact:
        • Principal Investigator:
          • Grace Orteza, MD
      • Quezon City, Metro Manila, Philippines
        • Recruiting
        • East Avenue Medical Center
        • Contact:
        • Principal Investigator:
          • Marissa Ong, MD
      • Quezon City, Metro Manila, Philippines
        • Recruiting
        • Quirino Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Jemelle Cano, MD
      • Quezon City, Metro Manila, Philippines
        • Not yet recruiting
        • St. Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Jacqueline Dominguez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen and evaluated at the participating sites are eligible to be included in the study if they fulfill all inclusion and none of the exclusion criteria.

Description

Inclusion Criteria

  • Patient with cognitive impairment diagnosed with Mild Cognitive Impairment or Dementia.
  • 18 years old or older.
  • Must be a Filipino Citizen.
  • Seen and evaluated in the participating hospital by a neurologist.
  • If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative.

Exclusion Criteria

• Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of dementia and mild cognitive impairment in the study population
Time Frame: on Day 1
To determine the frequency of dementia and mild cognitive impairment in the study
on Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F frequency of the different types of dementia in the study population
Time Frame: on Day 1
To determine the frequency of the different types of dementia in the study population using the clinical diagnosis
on Day 1
Frequency of risk factors for dementia in the study population
Time Frame: on Day 1
o determine the frequency of risk factors for dementia in the study population. (age, sex, educational attainment, family history, physical activity, smoking history, alcohol consumption, cardiovascular and cerebrovascular risk factors, chemical exposure, substance abuse, previous psychiatric condition and hearing impairment)
on Day 1
Demographic characteristics of patients with dementia or mild cognitive impairment
Time Frame: on Day 1
To describe the demographic characteristics of patients with dementia or mild cognitive impairment as to age at the time of diagnosis, age of onset of symptoms, sex, level of income (of patient or caregiver), location of clinic or hospital, current or previous occupation, educational attainment, neurologic exam findings
on Day 1
Dementia Severity
Time Frame: on Day 1
To categorize dementia severity in each subtype as mild, moderate and severe based on the initial MMSE score at the time of diagnosis.
on Day 1
Diagnostic tests used at the time of the diagnosis
Time Frame: on Day 1
To describe the types of diagnostic tests commonly done at the time of diagnosis, such as neuroimaging, blood tests, EEG
on Day 1
Pharmacologic and nonpharmacologic modalities used
Time Frame: on Day 1
To identify pharmacologic and nonpharmacologic modalities of treatment currently being used in the treatment of dementia
on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philippine Neurological Association

Collaborators

St. Luke's Medical Center, Philippines
University of Santo Tomas Hospital, Philippines
Makati Medical Center
Baguio General Hospital and Medical Center, Philippines
East Avenue Medical Center, Philippines
Jose R. Reyes Memorial Medical Center
Quirino Memorial Medical Center, Philippines
The Medical City, Philippines
University of the East- Ramon Magsaysay Memorial Medical Center, Philippines
University of the Philippines Manila - Philippine General Hospital
Chong Hua Hospital, Philippines

Investigators

  • Principal Investigator: Ma. Lourdes C Joson, MD, Philippine Neurological Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 17, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNA2020_0X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

To be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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