HypertensionLIGHTNCT03636334
Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT)
A study testing Computer-based decision support system in people with Hypertension, run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial summary
This trial aims to evaluate the effectiveness of a guideline-based decision support system for hypertension management by physicians at primary health care (PHC) centers in China in order to improve the delivery of appropriate treatment and blood pressure (BP) control for hypertensive individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Computer-based decision support system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 3 sitesChina
- Study dates
- 21 Aug 2019to 30 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one drug available from each of the four classes of recommended antihypertensive drugs are provided at clinic:
- A: Angiotensin-converting enzyme inhibitors (ACEI; e.g., captopril and nalapril) or angiotensin receptor blockers (ARB; e.g., losartan and valsartan)
- B: β-blockers (e.g., atenolol and metoprolol)
- C: Calcium antagonists (e.g., nitrendipine, nifedipine, and amlodipine)
- D: Diuretics (e.g., hydrochlorothiazide and indapamide)
- Has an outpatient clinic for hypertension treatment and staff willing to take part in the study
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- Electronic data collection system is routinely used at clinic for hypertension management
- At least 100 individuals with hypertension can attend the clinic every 3 months.
- Scheduled or unscheduled visit for hypertension treatment or prescription for antihypertensive medications
- Visit for elevated blood pressure or adverse effect of antihypertensive medications
- Visit for other cardiovascular diseases such as diabetes, stroke, PAD, or newly diagnosed of CKD, CAD and heart failure regardless of individuals' blood pressure level.
- Age ≥18 years
- Local resident of the community/township who attend the PHC clinic for hypertension management
- Established diagnosis of essential hypertension (defined as systolic blood pressure≥140 mmHg, diastolic blood pressure ≥90 mmHg, or both, measured on at least 3 separate visits; or currently taking antihypertensive medications)
- Taking 0-2 types of antihypertensive medications (not including B)
Who cannot join
- Patients with SBP≥180 mmHg and/or DBP≥110 mmHg
- History of coronary heart disease (i.e., angina, MI, coronary artery bypass grafting [CABG], percutaneous coronary intervention [PCI], >50% stenosis of coronary artery, or positive stress test)
- Physician- diagnosed heart failure
- Physician-diagnosed or self-reported CKD, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis
- Physician-diagnosed secondary hypertension
- Intolerance to at least two classes of antihypertensive medications among A, C or D
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- Other serious medical illness such as malignant cancer, hepatic dysfunction, et al
- Currently at the acute phase of any disease
- Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period
Trial locations and contacts
3 sites in 1 country.
China3 sites, 1 recruiting
- Completed
Luoyang Oriental hospital
Beijing, Henan
- Recruiting
Center for chronic disease control
Shenzhen, Shenzhen
Xin Zheng
- Active, not recruiting
Yankuang Hospital
Zoucheng, Shandong
About this study
Official title: Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT): A Staged Cluster Randomized Trial
This trial aims to evaluate the effectiveness of a guideline-based decision support system for hypertension management by physicians at primary health care (PHC) centers in China in order to improve the delivery of appropriate treatment and blood pressure (BP) control for hypertensive individuals.
Read the detailed description
The LIGHT trial aims to assess the effectiveness of decision support system (DSS) for hypertension treatment in cluster clinics. At each stage, the main randomization will occur at the PHC center level. During the first 3 months (baseline period), the physicians at all sites will use an electronic data collection system to collect information about the individuals who attend the clinic. After site randomization, physicians at control sites will continue to deliver usual care, and physicians at intervention sites will receive training and support on the use of the DSS. And the DSS will recommend antihypertensive medications according to the assigned protocol. All individuals will be asked to attend the clinic at least once every 3 months.
- Conditions
- Hypertension
- Being tested
- Computer-based decision support system
- Keywords
- Hypertension, Decision support system, Staged cluster randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based decision support systemBehavioural
At intervention sites, physicians will receive training and support on use of the DSS, which will be installed on their local IT system. Individuals eligible for DSS at Intervention sites will be randomized or assigned to different drug sequence protocols for BP-lowering therapy using their current antihypertensive medications, co-morbidities, and intolerance to medications and according to the assignment plan in the Algorithm. If the protocol is not suitable for the patient because of new co-morbidities, medication intolerance or contraindication, the DSS will recommend switching to a new protocol.
| Study group | Role | What they receive |
|---|---|---|
| Computer-based decision support system | Experimental | Computer-based decision support system for BP management, with appropriate training of local PHC doctors. Receives: Behavioral: Computer-based decision support system |
| Control | No intervention | After site randomization, physicians at the control sites will manage their patients with hypertension by usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of visits with ideal appropriate treatment provided among all the eligible hypertension visits within the period of observational follow-up
ideal appropriate treatment means guideline-accordant treatment
Measured: Baseline; 1 year
Secondary outcomes (3)
The average change in SBP from first visit after randomization to the last visit among the eligible participants during the period of 9-month observation.
the average change in SBP from first visit after randomization to the last visit among enrolled patients.
Measured: Baseline; 1 year
The percentage of participants with BP<140/90 mmHg at the last visit among the eligible participants during the period of 9-month observation.
The individuals' last blood pressure measurement during the 9-month observation phase will be used for assessment
Measured: Baseline; 1 year
The proportion of visits with acceptable appropriate treatment among all the eligible hypertension visits.
Acceptable appropriate treatments is defined as the recommendations offered by the doctors who are not following DSS on reasonable conditions, such as patient-reported normal home-measured blood pressure, hypotension or syncope before the visit.
Measured: Baseline; 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start21 Aug 2019
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xin Zheng, MD, PhD, Principal investigator, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636334
- Sponsor's protocol ID
- 2016-I2M-1-006-1
- Acronym
- LIGHT
- Status last verified
- Apr 2021
- First submitted
- 3 Jul 2018
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song J, Liu Y, Shang Q, Liu J, Zhang H, Zhou Z, Wang W, Lu J, Zheng X. Clinical Decision Support System, Antihypertensive Treatment Intensification, and Blood Pressure Control: A Post Hoc Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2026 May 1;9(5):e2614858. doi: 10.1001/jamanetworkopen.2026.14858.
PubMed 42201734Song J, Wang X, Wang B, Ge Y, Bi L, Jing F, Jin H, Li T, Gu B, Wang L, Hao J, Zhao Y, Liu J, Zhang H, Li X, Li J, Ma W, Wang J, Normand ST, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial. BMJ. 2024 Jul 23;386:e079143. doi: 10.1136/bmj-2023-079143.
PubMed 39043397Yi J, Wang L, Song J, Liu Y, Liu J, Zhang H, Lu J, Zheng X. Development of a machine learning-based model for predicting individual responses to antihypertensive treatments. Nutr Metab Cardiovasc Dis. 2024 Jul;34(7):1660-1669. doi: 10.1016/j.numecd.2024.02.014. Epub 2024 Mar 4.
PubMed 38555240Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials. 2022 May 16;23(1):412. doi: 10.1186/s13063-022-06374-x.
PubMed 35578345
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT): A Staged Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03636334
- Acronym / sponsor ID
- LIGHT / 2016-I2M-1-006-1
- Conditions
- Hypertension
- Keywords
- Hypertension, Decision support system, Staged cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 17 Aug 2018 (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 trial aims to evaluate the effectiveness of a guideline-based decision support system for hypertension management by physicians at primary health care (PHC) centers in China in order to improve the delivery of appropriate treatment and blood pressure (BP) control for hypertensive individuals.
Detailed description
The LIGHT trial aims to assess the effectiveness of decision support system (DSS) for hypertension treatment in cluster clinics. At each stage, the main randomization will occur at the PHC center level. During the first 3 months (baseline period), the physicians at all sites will use an electronic data collection system to collect information about the individuals who attend the clinic. After site randomization, physicians at control sites will continue to deliver usual care, and physicians at intervention sites will receive training and support on the use of the DSS. And the DSS will recommend antihypertensive medications according to the assigned protocol. All individuals will be asked to attend the clinic at least once every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-based decision support system | Experimental | Behavioral: Computer-based decision support systemComputer-based decision support system for BP management, with appropriate training of local PHC doctors. |
| Control | No intervention | –After site randomization, physicians at the control sites will manage their patients with hypertension by usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- At least one drug available from each of the four classes of recommended antihypertensive drugs are provided at clinic:
- Has an outpatient clinic for hypertension treatment and staff willing to take part in the study
- Electronic data collection system is routinely used at clinic for hypertension management
- At least 100 individuals with hypertension can attend the clinic every 3 months.
- Scheduled or unscheduled visit for hypertension treatment or prescription for antihypertensive medications
Key exclusion criteria (9 listed)
- Patients with SBP≥180 mmHg and/or DBP≥110 mmHg
- History of coronary heart disease (i.e., angina, MI, coronary artery bypass grafting [CABG], percutaneous coronary intervention [PCI], >50% stenosis of coronary artery, or positive stress test)
- Physician- diagnosed heart failure
- Physician-diagnosed or self-reported CKD, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis
- Physician-diagnosed secondary hypertension
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 |
|---|---|---|
| Computer-based decision support systemAt intervention sites, physicians will receive training and support on use of the DSS, which will be installed on their local IT system. Individuals eligible for DSS at Intervention sites will be randomized or assigned to different drug sequence protocols for BP-lowering therapy using their current antihypertensive medications, co-morbidities, and intolerance to medications and according to the assignment plan in the Algorithm. If the protocol is not suitable for the patient because of new co-morbidities, medication intolerance or contraindication, the DSS will recommend switching to a new protocol. | Behavioural | Computer-based decision support system |
Primary outcome
The proportion of visits with ideal appropriate treatment provided among all the eligible hypertension visits within the period of observational follow-up
Time frame: Baseline; 1 year
ideal appropriate treatment means guideline-accordant treatment
3 secondary outcomes
The average change in SBP from first visit after randomization to the last visit among the eligible participants during the period of 9-month observation.
Time frame: Baseline; 1 year
The percentage of participants with BP<140/90 mmHg at the last visit among the eligible participants during the period of 9-month observation.
Time frame: Baseline; 1 year
The proportion of visits with acceptable appropriate treatment among all the eligible hypertension visits.
Time frame: Baseline; 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 42201734Song J, Liu Y, Shang Q, Liu J, Zhang H, Zhou Z, Wang W, Lu J, Zheng X. Clinical Decision Support System, Antihypertensive Treatment Intensification, and Blood Pressure Control: A Post Hoc Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2026 May 1;9(5):e2614858. doi: 10.1001/jamanetworkopen.2026.14858.
- Derived from this study: PubMed 39043397Song J, Wang X, Wang B, Ge Y, Bi L, Jing F, Jin H, Li T, Gu B, Wang L, Hao J, Zhao Y, Liu J, Zhang H, Li X, Li J, Ma W, Wang J, Normand ST, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial. BMJ. 2024 Jul 23;386:e079143. doi: 10.1136/bmj-2023-079143.
- Derived from this study: PubMed 38555240Yi J, Wang L, Song J, Liu Y, Liu J, Zhang H, Lu J, Zheng X. Development of a machine learning-based model for predicting individual responses to antihypertensive treatments. Nutr Metab Cardiovasc Dis. 2024 Jul;34(7):1660-1669. doi: 10.1016/j.numecd.2024.02.014. Epub 2024 Mar 4.
- Derived from this study: PubMed 35578345Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials. 2022 May 16;23(1):412. doi: 10.1186/s13063-022-06374-x.
- Individual participant dataSharing planned: Undecided
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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.
Xin Zheng, MD, PhD principal investigator
National Center for Cardiovascular Diseases
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based decision support system in people with Hypertension, run by China National Center for Cardiovascular Diseases at 3 sites 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 15 inclusion and 9 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Xin Zheng, MD, PhD (+86 60866813, xin.zheng@fwoxford.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of visits with ideal appropriate treatment provided among all the eligible hypertension visits within the period of observational follow-up (time frame: Baseline; 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636334, which also lists 4 linked publications.
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 Apr 2021.