CUHK Brain Health Longitudinal Study

Stroke Clinical Trial

— BHS  

Official title:

CUHK Brain Health Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592563
• Other study ID #: Crec No. 2018.148
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 31, 2048

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Thomas Wai Hong LEUNG, FRCP
• Phone: 852-35053593
• Email: drtleung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to develop a large longitudinal cohort of individuals diagnosed with or at high risk for brain diseases (both neurological and psychiatric in nature), in order to identify risk factors that contribute to neurological and psychiatric diseases over time. The investigators seek to capture relevant information from medical records, electronically administered questionnaires and follow up phone-based interviews. The investigators expect to eventually have sufficient power from our dataset to examine risk factors for a variety of brain disorders, both individually and in aggregate. Our ultimate goal is to offer scientifically validated ways to preserve and promote brain health by working with our patients' needs and tracking their progress over time.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2048
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult = 18 years of age

2. 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

1. family history (first degree relative) one or more neurological and/or psychiatric conditions

2. 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

3. Subject provides informed consent by signing and dating the written informed consent form

4. Subject is willing to answer health questionnaires and be followed longitudinally

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Diseases
• Brain Ischemia
• Dementia
• Health Attitude
• Health Knowledge, Attitudes, Practice
• Health Personnel Attitude
• Healthy Aging
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke Syndrome
• Stroke, Acute
• Stroke, Ischemic

Intervention

Behavioral:
• Neuro-QoL questionnaire
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.

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors contributing to neurological and psychiatric diseases	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