- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592563
CUHK Brain Health Longitudinal Study (BHS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For those interested participants, our services coordinator, co-investigator or principal investigator will interview and explain the study in detail and obtain your consent. After signed the consent, the participant should complete the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire first, either on-site at CUHK Brain Health Centre located at Tsim Sha Tsui in Hong Kong, PWH or community centre. The questions in the questionnaire focus on the following: ability to participate in social roles, emotional and behavioral dyscontrol, fatigue, lower extremity function, stigma, upper extremity function, positive affect and well-being, satisfaction with social roles, cognitive function, anxiety and depression. These questions enable us to get a full picture of the participant's health. Participants in Green and yellow groups will receive this standard battery of questions. However, participants in Red group may receive an additional subset of questions based on their clinical diagnosis. Once again, all subjects are asked to complete this questionnaire for clinical evaluation purposes, regardless of whether or not they decide to participate in this study.
When the participant is willing to join the study, an evaluation would be scheduled. At that visit, our physician and/or study coordinator will review the participant's medical history, current concerns, and responses to the questionnaires. Diagnostic and therapeutic recommendations may be offered, as warranted. The investigator or physician will determine whether a follow-up clinic visit is warranted. Depending on the physician's recommendations, the participant will either participate in a research phone call in approximately 6 months, or will be scheduled for in person research follow up. In addition to the phone call or clinic visit, and will also receive an identical questionnaire to the first one by e-mail, by phone, or in person. Follow-up over time will continue (either in-person or over the phone) using the same questionnaires at approximately 6-month intervals. During follow-up, participant will be screened for new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
The proposed study does not involve formulating new diagnoses or directly offering treatment for neurological and/or psychiatric conditions. All patients admitted to PWH or other medical institutes will be treated according to the standard care at the corresponding institution, regardless of their decision to participate in this repository. Should results from this study lead to discovery of one or more factors associated with development of brain disease, the principal investigators, co-investigators, or study coordinator in the CUHK Brain Health Centre will inform, counsel and offer diagnostic and/or therapeutic recommendations to participants accordingly. The participants may be referred to relevant departments for follow-up clinical visits and may also be invited to participate in sister research projects at PWH/CUHK that have obtained ethics approval; if the participants are interested in any sister projects, they may be offered tests as the study procedures of these projects, including but not limited to blood tests, genetic tests, retinal imaging and brain imaging exams.
Our study aims to follow longitudinally individuals with or at risk for neurological and psychiatric disease, regardless of gender or sexual orientation. The investigators focus on enrolling adults as the vast majority of the neurological and psychiatric conditions of interest are diagnosed well into adulthood; indeed, most are age-related and particularly frequent among individuals in the fifth decade of life and beyond. Our study uniquely welcomes even individuals who are healthy from a brain standpoint, and offers them an opportunity to increase our scientific understanding of the early transition from normal to pathological brain functioning. As a result, the entire population as a whole stand to potentially benefit from the outcomes of the proposed research.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Thomas Wai Hong LEUNG, FRCP
- Phone Number: 852-35053593
- Email: drtleung@cuhk.edu.hk
Study Contact Backup
- Name: Tiffany Chung, M.Phil
- Phone Number: 852-35053856
- Email: tiffanyc@cuhk.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The Chinese University of Hong Kong
-
Contact:
- Thomas Wai Hong LEUNG, FRCP
- Phone Number: 852-35053593
- Email: drtleung@cuhk.edu.hk
-
Hong Kong, Hong Kong
- Recruiting
- Chinese University of Hong Kong
-
Contact:
- Thomas Wai Hong LEUNG, FRCP
- Phone Number: 852-35053593
- Email: drtleung@cuhk.edu.hk
-
Contact:
- Anki MIU, MSc
- Phone Number: 852-28902002
- Email: ankimiu@cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Chinese ONLY
- Hong Kong Resident
Description
Inclusion Criteria:
- Adult ≥ 18 years of age
Fulfilling criteria for membership in one of these three groups:
- Red group: established diagnosis of one or more neurological and/or psychiatric conditions
Yellow group: high-risk to develop one or more neurological and/or psychiatric conditions
- family history (first degree relative) one or more neurological and/or psychiatric conditions
- examination, imaging or laboratory findings consistent with pre-symptomatic stages of one or more neurological and/or psychiatric disorders
- Green group: not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of brain health
- Subject provides informed consent by signing and dating the written informed consent form
- Subject is willing to answer health questionnaires and be followed longitudinally
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Red group
Those participants who had established diagnosis of one or more neurological and/or psychiatric conditions Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire plus an additional subset of questions based on their clinical diagnosis should be done. |
Follow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals.
During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
|
Yellow group
Those participants who are high-risk to develop one or more neurological and/or psychiatric conditions, for example:
Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire should be done. |
Follow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals.
During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
|
Green group
Those participants who are not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of their brain health. Baseline: The participants' medical history would be recorded and Neuro-QoL questionnaire should be done. |
Follow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals.
During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors contributing to neurological and psychiatric diseases
Time Frame: December, 2038
|
The participants' electronic medical records and questionnaires done (either symptomatic or asymptomatic) would be compared with their follow-up electronic medical records/phone follow-up interview and questionnaires done over time.
|
December, 2038
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Wai Hong LEUNG, FRCP, Division of Neurology, The Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Stroke
- Ischemic Stroke
- Brain Ischemia
- Ischemia
- Dementia
- Alzheimer Disease
- Brain Diseases
Other Study ID Numbers
- Crec No. 2018.148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on Neuro-QoL questionnaire
-
Washington University School of MedicineUniversity of Texas; University of ConnecticutRecruiting
-
M.D. Anderson Cancer CenterWithdrawn
-
Centre Hospitalier Universitaire DijonCompleted
-
Spanish Breast Cancer Research GroupNovartis PharmaceuticalsCompletedBreast Carcinoma Metastatic to the BoneSpain
-
M.D. Anderson Cancer CenterCompletedLung Cancer | Non-small Cell Lung CancerUnited States
-
pfm medical agAix ScientificsTerminatedUrinary Incontinence, StressGermany
-
Vascutek Ltd.Active, not recruitingAortic Dissection | Aortic Aneurysm, Thoracic | Aortic Rupture | Penetrating Aortic Ulcer | Acute Aortic DissectionGermany, Canada, Italy, Netherlands
-
Campus Bio-Medico UniversityFederazione medicina sportiva italiana (FMSI)CompletedQuality of Life
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Memorial Sloan Kettering Cancer CenterComprehensive Cancer Centre The NetherlandsRecruitingCancer | Dermatologic ConditionsUnited States