HypertensionNCT06011213
Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG
A study testing Issuing health risk warning for a heat waves or cold spells, A digital heat or cold health risk early warning tool and Self-monitoring blood pressure and ECG device in people with Hypertension, run by Tiantian Li at 1 site in China.
Trial summary
This cluster-randomized trial, conducted in Tianjin, China, aims to evaluate the effectiveness of integrating a digital health risk early warning tool for heat with self-monitoring. Additionally, the study assesses the effectiveness of combining a digital health risk early warning tool for cold with self-monitoring. Read more about this study
- Who is it for?
- Ages 60 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Issuing health risk warning for a heat waves or cold spells, A digital heat or cold health risk early warning tool and Self-monitoring blood pressure and ECG device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 28 Feb 2024
- Phase
- Interventional
- 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 60 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 60 to 65 years Individuals with a diagnosis of hypertension Individuals with untreated blood pressure above 140/90 mm Hg
Who cannot join
- Having a history of coronary heart disease, heart failure, or stroke Unable to cooperate with follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
Beijing, 100021
About this study
Official title: Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and Electrocardiogram
This cluster-randomized trial, conducted in Tianjin, China, aims to evaluate the effectiveness of integrating a digital health risk early warning tool for heat with self-monitoring. Additionally, the study assesses the effectiveness of combining a digital health risk early warning tool for cold with self-monitoring. Communities from three districts will be randomly assigned to one of three groups: the combined intervention group (receiving health warnings via a WeChat mini-program and self-monitoring), the self-monitoring group (daily blood pressure (BP) and electrocardiogram (ECG) monitoring without warnings), and the control group (BP and ECG monitoring only during baseline and routine check-ups). The primary objective of the study is to evaluate the effectiveness of the intervention in improving blood pressure control and reducing the risk of electrocardiogram abnormalities, as well as understanding its underlying biological mechanisms.
Read the detailed description
This cluster-randomized trial will be conducted in various districts across Tianjin, China. As part of the early warning interventions for heat and cold, three communities from each of the two selected districts will be randomly chosen and assigned to one of three groups: the combined intervention group, the self-monitoring group, or the control group. The study will be divided into pre-intervention and intervention phases. The pre-intervention period for the heat wave health early-warning information intervention spans from July 1st, 2023, to July 7th, 2023, followed by the intervention period from July 8th to September 9th, 2023. Similarly, during the cold spell health early-warning information intervention, the pre-intervention phase occurs from December 1st, 2023, to December 7th, 2023, and the intervention.
Participants in the combined intervention group will receive heat health risk warnings via digital tools, specifically a WeChat mini-program, providing real-time updates on early warnings and health advisories. Additionally, they will be instructed to perform daily self-monitoring of their blood pressure (BP) and electrocardiogram (ECG) using automated home devices. Participants in the self-monitoring alone group will engage in daily BP and ECG monitoring but not receive any health warnings. In contrast, the control group will monitor their BP and ECG only during baseline assessments and routine health check-ups (the day after the first heat wave in July and August 2023, as well as following the first cold spell in January and February 2024).
All participants will be required to record their daily time-activity patterns. During the baseline and subsequent check-ups, data will be collected on participants' demographics, medical history, lifestyle factors (e.g., diet, smoking, physical activity), environmental exposures, sleep quality, mental health status (including stress levels, emotional stability, and psychological resilience), medication adherence, cardiovascular and cerebrovascular symptoms, respiratory system symptoms, and perceptions of heatwaves and cold spells. In addition, blood, urine, and stool samples will be gathered for further analysis.
- Conditions
- Hypertension
- Being tested
- Issuing health risk warning for a heat waves or cold spells, A digital heat or cold health risk early warning tool, Self-monitoring blood pressure and ECG device, Perform daily self-monitoring of their BP and ECG
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Issuing health risk warning for a heat waves or cold spellsBehavioural
Whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the combined intervention group will be alerted to the early warning information through the digital heat or cold health risk early warning tool.
A digital heat or cold health risk early warning toolDevice
A WeChat mini-program provides real-time updates on early warnings and health advisories.
Self-monitoring blood pressure and ECG deviceDevice
Devices for self-monitoring blood pressure and ECG
Perform daily self-monitoring of their BP and ECGBehavioural
Participants in the self-monitoring alone group were instructed to self-measure their BP three times each morning (from 6:00 a.m. to 8:00 a.m.) and evening (from 6:00 p.m. to 8:00 p.m.) at home, and to self-administer ECG measurements twice during the same morning and evening timeframes.
| Study group | Role | What they receive |
|---|---|---|
| Combined intervention | Experimental | Participants in the combined intervention group will receive real-time health risk warnings for heat waves and cold spells via a WeChat mini-program and will perform daily self-monitoring of BP and ECG using automated home devices. Receives: Behavioral: Issuing health risk warning for a heat waves or cold spells; Device: A digital heat or cold health risk early warning tool; Device: Self-monitoring blood pressure and ECG device; Behavioral: Perform daily self-monitoring of their BP and ECG |
| Self-monitoring alone | Other | Not described Receives: Device: Self-monitoring blood pressure and ECG device; Behavioral: Perform daily self-monitoring of their BP and ECG |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DBP
The DBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).
Measured: baseline, six months
Change from baseline in SBP
The SBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).
Measured: baseline, six months
Change from baseline in the risk of the overall warning level for abnormal ECG.
Overall warning level for abnormal ECG is measured by a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China). This device is employed to assess and report on the presence of abnormal ECG states.
Measured: baseline, six months
Secondary outcomes (24)
Change from baseline in the control rate of blood pressure (SBP/DBP <120/80 mm Hg)
The blood pressure was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China). The proportion of participants achieving a systolic blood pressure (SBP) below 120 mm Hg and a diastolic blood pressure (DBP) below 80 mm Hg is calculated by dividing the number of participants who meet these criteria by the total number of participants at baseline and each routine health check-up.
Measured: baseline, six months
Change from baseline in the control rate of blood pressure (SBP/DBP <140/90 mm Hg)
The blood pressure was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China). The proportion of participants achieving a systolic blood pressure (SBP) below 140 mm Hg and a diastolic blood pressure (DBP) below 90 mm Hg is calculated by dividing the number of participants who meet these criteria by the total number of participants at baseline and each routine health check-up.
Measured: baseline, six months
Change from baseline in left ventricular hypertrophy
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of left ventricular hypertrophy.
Measured: baseline, six months
Change from baseline in sinus arrhythmia
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of sinus arrhythmia.
Measured: baseline, six months
Change from baseline in right bundle branch block
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of right bundle branch block.
Measured: baseline, six months
Change from baseline in ventricular premature beats
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of ventricular premature beats.
Measured: baseline, six months
Change from baseline in atrial premature beats
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of atrial premature beats.
Measured: baseline, six months
Change from baseline in Q waves
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of Q waves.
Measured: baseline, six months
Change from baseline in T-wave changes
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of T-wave changes.
Measured: baseline, six months
Change from baseline in ST changes
The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of ST changes.
Measured: baseline, six months
Change from baseline in the heat wave and cold spell perception score
The heat wave and cold spell perception score is measured by the heat wave and cold spell perception questionnaire. This questionnaire captures participants' perceptions of heatwave-related health risks and their level of preparedness. Respondents rate their responses on a continuous scale from 0 to 100, with 0 representing "not at all" or "very low" and 100 representing "very much" or "very high," allowing them to express the degree of their perception and concern.
Measured: baseline, six months
Change from baseline in the PSQI score
The PSQI score is measured by the pittsburgh sleep quality index questionnaire. The PSQI consists of 19 individual items that assess seven key components of sleep: subjective sleep quality, sleep latency (the time it takes to fall asleep), sleep duration, habitual sleep efficiency (the ratio of total sleep time to time spent in bed), sleep disturbances, use of sleep medication, and daytime dysfunction.Each of the seven components is scored from 0 to 3, with the total PSQI score ranging from 0 to 21. A total score greater than 5 indicates poor sleep quality, while a lower score suggests good sleep quality.
Measured: baseline, six months
Change from baseline in the PHQ-9 score
The PHQ-9 score is measured by Patient Health Questionnaire-9. This questionnaire evaluates nine key symptoms of depression experienced over the past two weeks, including loss of interest or pleasure in activities, feeling down or hopeless, trouble sleeping, fatigue, poor appetite or overeating, feelings of worthlessness or failure, difficulty concentrating, physical agitation or slowing, and thoughts of self-harm or suicide. Each symptom is rated on a scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depression, respectively.
Measured: baseline, six months
Change from baseline in the MMSE score
The MMSE score is measured by the mini-mental state examination. This examination evaluates five main areas: orientation (to time and place), memory (short-term and long-term), attention and calculation (concentration and basic arithmetic), language (fluency and comprehension), and executive function (complex task performance). Each area is scored on a scale from 0 to 5, with a total score ranging from 0 to 30. Typically, a score above 24 indicates normal cognitive function, while a score below 24 may suggest cognitive impairment.
Measured: baseline, six months
Change from baseline in the GAD-7 score
The GAD-7 score is measured by the generalized anxiety disorder scale. This scale evaluates seven key symptoms of anxiety: feeling nervous, anxious, or on edge; not being able to stop or control worrying; worrying too much about different things; trouble relaxing; being so restless that it is hard to sit still; becoming easily annoyed or irritable; and feeling afraid as if something awful might happen. Each symptom is rated on a scale from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 21. A score of 5 or above indicates the presence of generalized anxiety disorder symptoms, with higher scores reflecting greater symptom severity.
Measured: baseline, six months
Change from baseline in the PSSS score
The PSSS score is measured by the perceived social support scale. This scale evaluates three key sources of support: family, friends, and significant others. It consists of 12 items, with four items each related to family, friends, and significant others. Participants rate their agreement with each statement on a scale from 1 (very strongly disagree) to 7 (very strongly agree), resulting in a total score ranging from 12 to 84, where higher scores indicate higher perceived social support.
Measured: baseline, six months
Change from baseline in time-activity patterns
The time-activity patterns is measured by the self-reported time-activity diaries questionnaire. This questionnaire captures duration spent in various settings (such as outdoor environments, workplaces, transportation, home, and other indoor areas) and at different intensity levels of physical activity were recorded.
Measured: baseline, six months
Change from baseline in HPSMBRS score
The HPSMBRS score is measured by the hypertension patient self-management behavior rating scale. The HPSMBRS consists of 33 individual items across six dimensions: medication management, condition monitoring, dietary management, exercise management, work-rest management, and emotional management. Each item is rated on a 1 to 5 Likert scale, with 1 indicating "never" and 5 indicating "always." The total score ranges from 33 to 165, with higher scores indicating better self-management. To ensure comparability across dimensions, individual scores are converted to standardized scores using the formula: standardized score = (actual ctual score of each factor / total score of each factor)×100. Self-management levels are categorized as low (<60), moderate (60~80), and high (>80) based on standardized scores.
Measured: baseline, six months
Change from baseline in HPMARS score
The HPMARS score is measured by the hypertension patient medication adherence rating scale. The HPMARS consists of 8 individual items that assess key components of medication adherence: forgetting to take medication, intentional non-adherence, reducing or stopping medication due to side effects without consulting a doctor, forgetting medication during travel, forgetting to take medication the previous day, reducing dosage after symptoms are controlled, inconvenience of daily medication with maintaining adherence, and the frequency of forgetting to take medication. Each item is scored as 1 or 0, with the total HPMARS score ranging from 0 to 8. A total score of 8 indicates high adherence, 6 to 7 indicates moderate adherence, and a score below 6 suggests low adherence.
Measured: baseline, six months
Changes in liver function biomarkers (e.g., albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), etc.) from baseline
This section evaluates changes in liver function biomarkers using appropriate omics technologies to explore their potential role in liver-related diseases.
Measured: baseline, six months
Changes in kidney function biomarkers (e.g., uric acid (UA), blood urea nitrogen (BUN), creatinine (CREA), etc.) from baseline
This section assesses changes in kidney function biomarkers through suitable omics techniques, investigating their involvement in kidney disorders.
Measured: baseline, six months
Changes in cardiovascular biomarkers (e.g., creatine kinase-MB (CK-MB), creatine kinase (CK), etc.) from baseline
This section assesses changes in cardiovascular function biomarkers through suitable omics techniques, investigating their involvement in cardiovascular diseases.
Measured: baseline, six months
Changes in inflammatory biomarkers (e.g., interleukin-6 (IL-6), interleukin-1β (IL-1β), etc.) from baseline
This section examines the alterations in inflammatory biomarkers using relevant omics approaches, aiming to uncover their potential role in inflammatory and immune responses.
Measured: baseline, six months
Changes in metabolic biomarkers (e.g., lactate dehydrogenase (LDH), high-density lipoprotein (HDL), low-density lipoprotein cholesterol (LDL) , etc.) from baseline
This section examines the alterations in metabolic biomarkers using relevant omics approaches, aiming to uncover their potential implications in metabolic processes and health outcomes.
Measured: baseline, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jul 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiantian Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tiantian Li, Centers for Disease Control and Prevention, China
- Investigators
- Tiantian Li, Study director, National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011213
- Sponsor's protocol ID
- 202361
- Status last verified
- Jan 2025
- First submitted
- 4 Jun 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and Electrocardiogram
- ClinicalTrials.gov ID
- NCT06011213
- Acronym / sponsor ID
- 202361
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Tiantian LiOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 25 Aug 2023 (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 cluster-randomized trial, conducted in Tianjin, China, aims to evaluate the effectiveness of integrating a digital health risk early warning tool for heat with self-monitoring. Additionally, the study assesses the effectiveness of combining a digital health risk early warning tool for cold with self-monitoring. Communities from three districts will be randomly assigned to one of three groups: the combined intervention group (receiving health warnings via a WeChat mini-program and self-monitoring), the self-monitoring group (daily blood pressure (BP) and electrocardiogram (ECG) monitoring without warnings), and the control group (BP and ECG monitoring only during baseline and routine check-ups). The primary objective of the study is to evaluate the effectiveness of the intervention in improving blood pressure control and reducing the risk of electrocardiogram abnormalities, as well as understanding its underlying biological mechanisms.
Detailed description
This cluster-randomized trial will be conducted in various districts across Tianjin, China. As part of the early warning interventions for heat and cold, three communities from each of the two selected districts will be randomly chosen and assigned to one of three groups: the combined intervention group, the self-monitoring group, or the control group. The study will be divided into pre-intervention and intervention phases. The pre-intervention period for the heat wave health early-warning information intervention spans from July 1st, 2023, to July 7th, 2023, followed by the intervention period from July 8th to September 9th, 2023. Similarly, during the cold spell health early-warning information intervention, the pre-intervention phase occurs from December 1st, 2023, to December 7th, 2023, and the intervention.
Participants in the combined intervention group will receive heat health risk warnings via digital tools, specifically a WeChat mini-program, providing real-time updates on early warnings and health advisories. Additionally, they will be instructed to perform daily self-monitoring of their blood pressure (BP) and electrocardiogram (ECG) using automated home devices. Participants in the self-monitoring alone group will engage in daily BP and ECG monitoring but not receive any health warnings. In contrast, the control group will monitor their BP and ECG only during baseline assessments and routine health check-ups (the day after the first heat wave in July and August 2023, as well as following the first cold spell in January and February 2024).
All participants will be required to record their daily time-activity patterns. During the baseline and subsequent check-ups, data will be collected on participants' demographics, medical history, lifestyle factors (e.g., diet, smoking, physical activity), environmental exposures, sleep quality, mental health status (including stress levels, emotional stability, and psychological resilience), medication adherence, cardiovascular and cerebrovascular symptoms, respiratory system symptoms, and perceptions of heatwaves and cold spells. In addition, blood, urine, and stool samples will be gathered for further analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined intervention | Experimental | Behavioral: Issuing health risk warning for a heat waves or cold spells, Device: A digital heat or cold health risk early warning tool, Device: Self-monitoring blood pressure and ECG device, Behavioral: Perform daily self-monitoring of their BP and ECGParticipants in the combined intervention group will receive real-time health risk warnings for heat waves and cold spells via a WeChat mini-program and will perform daily self-monitoring of BP and ECG using automated home devices. |
| Self-monitoring alone | Other | Device: Self-monitoring blood pressure and ECG device, Behavioral: Perform daily self-monitoring of their BP and ECG |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged 60 to 65 years Individuals with a diagnosis of hypertension Individuals with untreated blood pressure above 140/90 mm Hg
Key exclusion criteria (1 listed)
- Having a history of coronary heart disease, heart failure, or stroke Unable to cooperate with follow-up
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 |
|---|---|---|
| Issuing health risk warning for a heat waves or cold spellsWhenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the combined intervention group will be alerted to the early warning information through the digital heat or cold health risk early warning tool. | Behavioural | Combined intervention |
| A digital heat or cold health risk early warning toolA WeChat mini-program provides real-time updates on early warnings and health advisories. | Device | Combined intervention |
| Self-monitoring blood pressure and ECG deviceDevices for self-monitoring blood pressure and ECG | Device | Combined intervention, Self-monitoring alone |
| Perform daily self-monitoring of their BP and ECGParticipants in the self-monitoring alone group were instructed to self-measure their BP three times each morning (from 6:00 a.m. to 8:00 a.m.) and evening (from 6:00 p.m. to 8:00 p.m.) at home, and to self-administer ECG measurements twice during the same morning and evening timeframes. | Behavioural | Combined intervention, Self-monitoring alone |
Primary outcome
Change from baseline in DBP
Time frame: baseline, six months
The DBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).
Change from baseline in SBP
Time frame: baseline, six months
The SBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).
Change from baseline in the risk of the overall warning level for abnormal ECG.
Time frame: baseline, six months
Overall warning level for abnormal ECG is measured by a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China). This device is employed to assess and report on the presence of abnormal ECG states.
24 secondary outcomes
Change from baseline in the control rate of blood pressure (SBP/DBP <120/80 mm Hg)
Time frame: baseline, six months
Change from baseline in the control rate of blood pressure (SBP/DBP <140/90 mm Hg)
Time frame: baseline, six months
Change from baseline in left ventricular hypertrophy
Time frame: baseline, six months
Change from baseline in sinus arrhythmia
Time frame: baseline, six months
Change from baseline in right bundle branch block
Time frame: baseline, six months
Change from baseline in ventricular premature beats
Time frame: baseline, six months
Change from baseline in atrial premature beats
Time frame: baseline, six months
Change from baseline in Q waves
Time frame: baseline, six months
Change from baseline in T-wave changes
Time frame: baseline, six months
Change from baseline in ST changes
Time frame: baseline, six months
Change from baseline in the heat wave and cold spell perception score
Time frame: baseline, six months
Change from baseline in the PSQI score
Time frame: baseline, six months
Change from baseline in the PHQ-9 score
Time frame: baseline, six months
Change from baseline in the MMSE score
Time frame: baseline, six months
Change from baseline in the GAD-7 score
Time frame: baseline, six months
Change from baseline in the PSSS score
Time frame: baseline, six months
Change from baseline in time-activity patterns
Time frame: baseline, six months
Change from baseline in HPSMBRS score
Time frame: baseline, six months
Change from baseline in HPMARS score
Time frame: baseline, six months
Changes in liver function biomarkers (e.g., albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), etc.) from baseline
Time frame: baseline, six months
Changes in kidney function biomarkers (e.g., uric acid (UA), blood urea nitrogen (BUN), creatinine (CREA), etc.) from baseline
Time frame: baseline, six months
Changes in cardiovascular biomarkers (e.g., creatine kinase-MB (CK-MB), creatine kinase (CK), etc.) from baseline
Time frame: baseline, six months
Changes in inflammatory biomarkers (e.g., interleukin-6 (IL-6), interleukin-1β (IL-1β), etc.) from baseline
Time frame: baseline, six months
Changes in metabolic biomarkers (e.g., lactate dehydrogenase (LDH), high-density lipoprotein (HDL), low-density lipoprotein cholesterol (LDL) , etc.) from baseline
Time frame: baseline, six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
Tiantian Li study director
National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Issuing health risk warning for a heat waves or cold spells, A digital heat or cold health risk early warning tool and Self-monitoring blood pressure and ECG device in people with Hypertension, run by Tiantian Li 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: finished, as of the sponsor's last update on 24 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in DBP (time frame: baseline, six months). The study lists 3 primary outcomes in all. 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 24 Jan 2025.