HypertensionNCT04718857
Chronic Disease Health Management Information Platform
An observational study of Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Based on the combination of domestic and foreign experience and the needs of patients as the orientation, this research gives full play to the hospital's advantages in chronic disease management, and uses network information technology to develop a systematic and intelligent system that integrates prevention… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Online education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to Dec 2021
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Young and middle-aged patients with essential hypertension in the Cardiovascular Outpatient Department of a tertiary A general hospital
Who may be able to join
- Patients who are 18 to 59 years old according to the World Health Organization (WHO) age classification criteria, meet the diagnostic criteria for hypertension published in the "Guidelines for the Prevention and Control of Hypertension in China", and are diagnosed with essential hypertension;
- Patients are conscious and possess Normal reading, comprehension and expression skills;
- use a smart phone to surf the Internet and send and receive information, accept and use the outpatient chronic disease health management platform services;
- Informed consent, voluntarily participate in this research.
Who cannot join
- Patients with severe organic heart disease and other cardiovascular and cerebrovascular diseases;
- Chronic liver and kidney failure;
- Patients with malignant tumors;
- Persons who have participated in other forms of Internet + health management.
Trial locations and contacts
1 site in 1 country.
China1 site
Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: The Construction and Empirical Research of Hospital Chronic Disease Health Management Information Platform From the Perspective of Internet
Based on the combination of domestic and foreign experience and the needs of patients as the orientation, this research gives full play to the hospital's advantages in chronic disease management, and uses network information technology to develop a systematic and intelligent system that integrates prevention, diagnosis and treatment, follow-up, and education.
Read the detailed description
Patients with hypertension are showing a trend of getting younger and younger, and high-normal blood pressure is increasing rapidly among the young and middle-aged people aged less than 65 years.
Young and middle-aged patients with hypertension have a lower absolute short-term cardiovascular risk, but their lifetime risk is higher.
Studies have shown that the awareness rate, treatment rate and control rate ("three rates") of young and middle-aged hypertensive patients in my country need to be improved urgently.
Improving the knowledge and behavior of young and middle-aged hypertensive patients with disease, treatment compliance and self-health management has become the focus of research.
"Internet + medical" through information network technology, innovative service models have become a trend.
- Conditions
- Hypertension
- Being tested
- Online education
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online educationBehavioural
health education
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy level
The individual's ability to acquire, understand, evaluate and exchange information in different environments throughout the life process to improve, maintain and improve health
Measured: 1 YEAR
Self-management behavior ability
The self-management behavior assessment scale for hypertensive patients includes six dimensions of medication management, condition monitoring, diet management, exercise management, rest and work management, and emotional management, as well as the assessment of the total level of self-management. There are 33 items in total, the sum of the scores of each item For the final total score of the scale, the items use Likert 5-level scoring method, which is always (5 points), often (4 points), sometimes (3 points), rarely (2 points), never (1 point).
Measured: 1 YEAR
Blood pressure compliance rate
The "Guidelines for the Prevention and Treatment of Hypertension in China (2018 Revised Edition)" recommends that blood pressure be reduced to <140/90 mmHg. In this study, the blood pressure compliance rate means that the patient's blood pressure measurement value is less than 140/90mmHg and stable for more than one month. Blood pressure compliance rate = number of people meeting blood pressure/total number of people receiving chronic disease management in outpatient clinics * 100%.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Sep 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Intervention change
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FANG LIANGYU, Study director, Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718857
- Sponsor's protocol ID
- 2020-701
- Status last verified
- Jan 2021
- First submitted
- 3 Dec 2020
- Last updated
- 15 Mar 2023
- Results posted
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction and Empirical Research of Hospital Chronic Disease Health Management Information Platform From the Perspective of Internet
- ClinicalTrials.gov ID
- NCT04718857
- Acronym / sponsor ID
- 2020-701
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Intervention change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Jan 2021 (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.
Based on the combination of domestic and foreign experience and the needs of patients as the orientation, this research gives full play to the hospital's advantages in chronic disease management, and uses network information technology to develop a systematic and intelligent system that integrates prevention, diagnosis and treatment, follow-up, and education.
Detailed description
Patients with hypertension are showing a trend of getting younger and younger, and high-normal blood pressure is increasing rapidly among the young and middle-aged people aged less than 65 years.
Young and middle-aged patients with hypertension have a lower absolute short-term cardiovascular risk, but their lifetime risk is higher.
Studies have shown that the awareness rate, treatment rate and control rate ("three rates") of young and middle-aged hypertensive patients in my country need to be improved urgently.
Improving the knowledge and behavior of young and middle-aged hypertensive patients with disease, treatment compliance and self-health management has become the focus of research.
"Internet + medical" through information network technology, innovative service models have become a trend.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young and middle-aged patients with essential hypertension in the Cardiovascular Outpatient Department of a tertiary A general hospital
Key inclusion criteria (4 listed)
- Patients who are 18 to 59 years old according to the World Health Organization (WHO) age classification criteria, meet the diagnostic criteria for hypertension published in the "Guidelines for the Prevention and Control of Hypertension in China", and are diagnosed with essential hypertension;
- Patients are conscious and possess Normal reading, comprehension and expression skills;
- use a smart phone to surf the Internet and send and receive information, accept and use the outpatient chronic disease health management platform services;
- Informed consent, voluntarily participate in this research.
Key exclusion criteria (4 listed)
- Patients with severe organic heart disease and other cardiovascular and cerebrovascular diseases;
- Chronic liver and kidney failure;
- Patients with malignant tumors;
- Persons who have participated in other forms of Internet + health management.
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 |
|---|---|---|
| Online educationhealth education | Behavioural | – |
Primary outcome
Health literacy level
Time frame: 1 YEAR
The individual's ability to acquire, understand, evaluate and exchange information in different environments throughout the life process to improve, maintain and improve health
Self-management behavior ability
Time frame: 1 YEAR
The self-management behavior assessment scale for hypertensive patients includes six dimensions of medication management, condition monitoring, diet management, exercise management, rest and work management, and emotional management, as well as the assessment of the total level of self-management. There are 33 items in total, the sum of the scores of each item For the final total score of the scale, the items use Likert 5-level scoring method, which is always (5 points), often (4 points), sometimes (3 points), rarely (2 points), never (1 point).
Blood pressure compliance rate
Time frame: 1 YEAR
The "Guidelines for the Prevention and Treatment of Hypertension in China (2018 Revised Edition)" recommends that blood pressure be reduced to <140/90 mmHg. In this study, the blood pressure compliance rate means that the patient's blood pressure measurement value is less than 140/90mmHg and stable for more than one month. Blood pressure compliance rate = number of people meeting blood pressure/total number of people receiving chronic disease management in outpatient clinics * 100%.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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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.
FANG LIANGYU study director
Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine
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 Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Mar 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Health literacy level (time frame: 1 YEAR). 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 15 Mar 2023.