跳至主要内容
临床试验/NCT03592563
NCT03592563招募中不适用

CUHK Brain Health Longitudinal Study

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
2
主要终点
Risk factors contributing to neurological and psychiatric diseases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Neuro-QoL questionnaire (Behavioral)

Yellow group

Those participants who are high-risk to develop one or more neurological and/or psychiatric conditions, for example:

  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.

Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire should be done.

干预措施: Neuro-QoL questionnaire (Behavioral)

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.

干预措施: Neuro-QoL questionnaire (Behavioral)

结局指标

主要结局

Risk factors contributing to neurological and psychiatric diseases

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leung Wai Hong Thomas

Professor

Chinese University of Hong Kong

研究点 (2)

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CUHK Brain Health Longitudinal Study | 临床试验