the Health Status of the Oldest OldNCT04553874
Health Status of the Oldest-old Population
An observational study of the Health Status of the Oldest Old, run by Peking University at 1 site in China.
Trial summary
This study aims to investigate the health status of the oldest-old population and to explore the key factors associated with their quality of life The study will select all the elderly aged 85 years and above from Lanqiying Community, Qinghuayuan Street, Haidian District, Beijing, and enroll them after informed… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- the Health Status of the Oldest Old
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All the people aged 80 years and above in the target community in Beijing will be enrolled, and people who were hospitalized for long period (6 months or more) or at the end of their lives were excluded.
Who may be able to join
- All the people aged 80 years and above in the target community in Beijing
Who cannot join
- People who were hospitalized for long period (6 months or more) or at the end of their lives were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191
About this study
Official title: Health Status of the Oldest-old Population: a Population-based, Cohort Study
This study aims to investigate the health status of the oldest-old population and to explore the key factors associated with their quality of life The study will select all the elderly aged 85 years and above from Lanqiying Community, Qinghuayuan Street, Haidian District, Beijing, and enroll them after informed consent. Demographic, sociological, economic, physiological information and disease-related records will be collected through questionnaire interviews, scales, and examinations.
After the first survey, the participants will be followed for 2 years to collect information about deaths or major health events. The baseline survey will be re-conducted two years later.
Read the detailed description
This study is a population-based cohort study. Oldest-old people (aged 80 and over) will be enrolled.
Data collection Social economics information include: name, gender, age, nationality, marital status, personal habits, occupation, level of education, family living situation, monthly income, way to go to a doctor and medical payment, etc The health status and disease will be obtained by review the medical records as well as the narration of the subjects and their family members. We will focus on diseases with high disability mortality, high social burden. Multiple indicators or abilities will be evaluated through the scale, including life or acting ability, nutritional status, cognitive ability, psychological status, social support, quality of life self-assessment, etc., so as to comprehensively understand the comprehensive information of the participants.
Basic physical examination and special clinical examination will be performed to obtain multiple objective indicators reflecting the subject's physical function The basic health examination includes; Blood pressure, respiration, heart rate, pulse; Height, weight, waist circumference, hip circumference, arm circumference, calf circumference, grip strength, vital capacity, tooth condition, hearing condition, visual acuity, ECG, etc.
Special examinations include the blood, urine, and stool specimens. Imageological examination like MRI, fundus photography, and optical coherence tomography will also be conducted.
- Conditions
- the Health Status of the Oldest Old
- Keywords
- oldest-old; epidemiology; population-based; cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
observational study without intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The incidence of death during the study period
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Health Status of the Oldest OldStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Principal investigator, Chun Zhang, Peking University
- Investigators
- chun Zhang, doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553874
- Sponsor's protocol ID
- IRB00006761-M2020021
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status of the Oldest-old Population: a Population-based, Cohort Study
- ClinicalTrials.gov ID
- NCT04553874
- Acronym / sponsor ID
- IRB00006761-M2020021
- Conditions
- the Health Status of the Oldest Old
- Keywords
- oldest-old; epidemiology; population-based; cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the health status of the oldest-old population and to explore the key factors associated with their quality of life The study will select all the elderly aged 85 years and above from Lanqiying Community, Qinghuayuan Street, Haidian District, Beijing, and enroll them after informed consent. Demographic, sociological, economic, physiological information and disease-related records will be collected through questionnaire interviews, scales, and examinations.
After the first survey, the participants will be followed for 2 years to collect information about deaths or major health events. The baseline survey will be re-conducted two years later.
Detailed description
This study is a population-based cohort study. Oldest-old people (aged 80 and over) will be enrolled.
Data collection Social economics information include: name, gender, age, nationality, marital status, personal habits, occupation, level of education, family living situation, monthly income, way to go to a doctor and medical payment, etc The health status and disease will be obtained by review the medical records as well as the narration of the subjects and their family members. We will focus on diseases with high disability mortality, high social burden. Multiple indicators or abilities will be evaluated through the scale, including life or acting ability, nutritional status, cognitive ability, psychological status, social support, quality of life self-assessment, etc., so as to comprehensively understand the comprehensive information of the participants.
Basic physical examination and special clinical examination will be performed to obtain multiple objective indicators reflecting the subject's physical function The basic health examination includes; Blood pressure, respiration, heart rate, pulse; Height, weight, waist circumference, hip circumference, arm circumference, calf circumference, grip strength, vital capacity, tooth condition, hearing condition, visual acuity, ECG, etc.
Special examinations include the blood, urine, and stool specimens. Imageological examination like MRI, fundus photography, and optical coherence tomography will also be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All the people aged 80 years and above in the target community in Beijing will be enrolled, and people who were hospitalized for long period (6 months or more) or at the end of their lives were excluded.
Key inclusion criteria (1 listed)
- All the people aged 80 years and above in the target community in Beijing
Key exclusion criteria (1 listed)
- People who were hospitalized for long period (6 months or more) or at the end of their lives were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study without intervention | Other | – |
Primary outcome
Death
Time frame: 3 years
The incidence of death during the study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chun Zhang, doctor principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Health Status of the Oldest Old, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chun zhang, doctor (8618601031059, zhangc1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.