Lifestyle AlterationNCT04550312
The Impact of Lifestyle Changes on Non-COVID Deaths
An observational study of Lifestyle Alteration and Non-COVID Deaths, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Alteration, Non-COVID Deaths
- How many people
- 80,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to Oct 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all cases of non-Covid-19 deaths in Xuzhou region between 2018 and 2020
Who may be able to join
- All cases of death reported to the Xuzhou CDC during the study period
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Medical University affiliated Hospital
Xuzhou, Jiangsu, 221000
Ming Chu, PHD
Chenzong Li, PHD
About this study
Official title: The Impact of Lifestyle Alteration by Strict Prevention Measures on Non-COVID Deaths in the Region With Low COVID-19 Transmission Rate
The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.
Read the detailed description
Background The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.
Methods The number of registered deaths among 8.8 million permanent residents with specific causes from January 2018 to June 2020 were sourced from the Xuzhou Center for Disease Control and Prevention, Jiangsu Province, China. Death rates were calculated and compared by weeks, months, and years with a focus on the period of COVID-19 pandemic from Jan 24 to March 27, 2020. Numeric values of all-cause death and the death rates of non-COVID diseases were compared in time series at different time scales.
- Conditions
- Lifestyle Alteration, Non-COVID Deaths
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric values of all-cause death and the death rates of non-COVID diseases
Measured: from January 2018 to June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle AlterationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- minglong chen, PHD, Principal investigator, Xuzhou Medical University affiliated hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550312
- Sponsor's protocol ID
- XYFY2020-KL142-01
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lifestyle Alteration by Strict Prevention Measures on Non-COVID Deaths in the Region With Low COVID-19 Transmission Rate
- ClinicalTrials.gov ID
- NCT04550312
- Acronym / sponsor ID
- XYFY2020-KL142-01
- Conditions
- Lifestyle Alteration, Non-COVID Deaths
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 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.
The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.
Detailed description
Background The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.
Methods The number of registered deaths among 8.8 million permanent residents with specific causes from January 2018 to June 2020 were sourced from the Xuzhou Center for Disease Control and Prevention, Jiangsu Province, China. Death rates were calculated and compared by weeks, months, and years with a focus on the period of COVID-19 pandemic from Jan 24 to March 27, 2020. Numeric values of all-cause death and the death rates of non-COVID diseases were compared in time series at different time scales.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all cases of non-Covid-19 deaths in Xuzhou region between 2018 and 2020
Key inclusion criteria (1 listed)
- All cases of death reported to the Xuzhou CDC during the study period
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric values of all-cause death and the death rates of non-COVID diseases
Time frame: from January 2018 to June 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
minglong chen, PHD principal investigator
Xuzhou Medical University affiliated 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 Lifestyle Alteration and Non-COVID Deaths, run by The First Affiliated Hospital with Nanjing Medical 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 16 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 ming chu, PHD (86-2568136965, chuming@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric values of all-cause death and the death rates of non-COVID diseases (time frame: from January 2018 to June 2020). 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 16 Sep 2020.