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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in China

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 groups in NCT06011213
Study groupRoleWhat they receive
Combined interventionExperimentalParticipants 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 aloneOtherNot described
Receives: Device: Self-monitoring blood pressure and ECG device; Behavioral: Perform daily self-monitoring of their BP and ECG
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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.

  1. First posted25 Aug 2023
  2. Study start1 Jul 2023
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

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)
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

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.

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