HypertensionNCT02919033
Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China
A study testing Self-management and PCTM intervention in people with Hypertension, run by Xu Lei at 1 site in China.
Trial summary
This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Self-management and PCTM intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Aug 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21 years or older
- a clinical diagnosis of hypertension with uncontrolled BP in the previous three months, currently taking or about to take anti-hypertensive medications
- received high school or above level of education
- active user of smart phone (Android or Apple) and mobile Apps
- the average of three BP measurements during the screening visit at the CHC is ≥ 140/90 mm Hg, or ≥ 130/80 mm Hg if the patient has diabetes or renal diseases;
- being able to give informed consent.
Who cannot join
- acute coronary syndrome
- heart failure
- cardiac arrhythmia
- stroke within the past three months
- renal failure
- cancer
Show all 9Show fewer
- dementia, severe or acute psychiatric illness, pregnancy or intention to be pregnant in the next 18 months, and hospitalization within 3 months.
- additional exclusion criteria include participation in another clinical trial, arm
- circumference >32 centimeters that may affect the accuracy of BP measurement due to cuff size limit of the tele-monitor's, and unwillingness to comply with the 12 month intervention duration.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hostpital
Shanghai, Shanghai Municipality, 200030
Lei Xu, Master, 86-21-32260806, waqyl@126.com
About this study
Official title: A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.
Read the detailed description
Background: Hypertension is a major risk factor for cardiovascular diseases and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCP) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-Cardiologist model that applies telemedicine tools to facilitate community hypertension control in China.
Methods/Design: Hypertensive patients receiving care at four community healthcare centers (CHCs) that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have uncontrolled blood pressure in the previous three months and access to mobile internet. Study subjects are randomly assigned to three interventional groups: 1) usual care; 2) home-based BP tele-monitor with embedded GSM module and unlimited data plan, an App to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or 3) this plus coordinated PCP-Cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure (SBP) over a 12-month period. Secondary outcomes are changes of diastolic blood pressure (DBP), HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale MMAS.
Discussion: This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model (PCTM) that incorporates the lasted telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of uncontrolled hypertensive patients.
- Conditions
- Hypertension
- Being tested
- Usual care, Self-management, PCTM intervention
- Keywords
- randomized controlled trial, telemedicine, hypertension, primary care, medication adherence
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
The hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients.
Self-managementDevice
- Usual care
- Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging.
- All patients receive proficiency training in using the BP tele-monitor, and mobile App.
PCTM interventionOther
- Usual care
- Self-management
- PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs.
- PCPs and cardiologists receive training of the CareLinker website.
| Study group | Role | What they receive |
|---|---|---|
| Usual care (UC) | Placebo comparator | Patients are managed by their PCPs at the registered CHCs as usual. Receives: Other: Usual care |
| Self-management | Experimental | * BP tele-monitor \& App based self-management supports
* Patient proficiency training Receives: Device: Self-management |
| PCTM intervention | Experimental | * BP tele-monitor \& App-based self-management supports
* Patient proficiency training
* PCP \& cardiologist training of using Web-based analytics
* Proactive and interactive care by PCPs and cardiologists Receives: Other: PCTM intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean SBP
The primary endpoint of the trial is changes in mean SBP from baseline (T1) to 12 months (T3) measured using the BP tele-monitor (Bliss BL928). The 12 months BP readings will be determined by taking the average of three BP measurements at the follow-up visit to the CHC. All BP data are collected and uploaded simultaneously to the trial database.
Measured: From baseline (T1) to 12 months (T3)
Secondary outcomes (3)
Changes in mean DBP
Changes of DBP will be determined at the same time as SBP, as described in the session of "Primary Outcome Measure"
Measured: From baseline (T1) to 12 months (T3)
Hypertension control rate
Hypertension control rate defined as BP < 140/90 mm Hg or < 130/80 mm Hg (patients of diabetes or renal diseases) following the national guidelines, and changes in measures related to hypertension complications (HbA1C, BMI, and lipid levels) from baseline (T1) to 6 months (T2) and 12 months (T3).
Measured: From baseline (T1) to 6 months (T2) and 12 months (T3)
Anti-hypertensive medication adherence
Adherence is assessed by self-report, eight-item Morisky Medication Adherence Scale MMAS modified to focus on BP drugs at baseline (T1) and 12 months (T3).
Measured: At baseline (T1) and 12 months (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Lei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Lei, Shanghai Chest Hospital
- Investigators
- Lei Xu, Master, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919033
- Sponsor's protocol ID
- SHDC12015308
- Status last verified
- Sep 2016
- First submitted
- 23 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, Vos T, Wang H, Lopez AD, Murray CJ. Rapid health transition in China, 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Jun 8;381(9882):1987-2015. doi: 10.1016/S0140-6736(13)61097-1.
PubMed 23746901Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009 May 19;338:b1665. doi: 10.1136/bmj.b1665.
PubMed 19454737Dickinson HO, Mason JM, Nicolson DJ, Campbell F, Beyer FR, Cook JV, Williams B, Ford GA. Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials. J Hypertens. 2006 Feb;24(2):215-33. doi: 10.1097/01.hjh.0000199800.72563.26.
PubMed 16508562Blood Pressure Lowering Treatment Trialists' Collaboration. Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data. Lancet. 2014 Aug 16;384(9943):591-598. doi: 10.1016/S0140-6736(14)61212-5.
PubMed 25131978Kumar N, Khunger M, Gupta A, Garg N. A content analysis of smartphone-based applications for hypertension management. J Am Soc Hypertens. 2015 Feb;9(2):130-6. doi: 10.1016/j.jash.2014.12.001. Epub 2014 Dec 11.
PubMed 25660364Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008 Jun;10(3):160-8. doi: 10.1089/dia.2008.0283.
PubMed 18473689Pfaeffli Dale L, Whittaker R, Jiang Y, Stewart R, Rolleston A, Maddison R. Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial. J Med Internet Res. 2015 Oct 21;17(10):e237. doi: 10.2196/jmir.4944.
PubMed 26490012Fernandez-Granero MA, Sanchez-Morillo D, Leon-Jimenez A. Computerised Analysis of Telemonitored Respiratory Sounds for Predicting Acute Exacerbations of COPD. Sensors (Basel). 2015 Oct 23;15(10):26978-96. doi: 10.3390/s151026978.
PubMed 26512667Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. doi: 10.2337/dc11-0366. Epub 2011 Jul 25.
PubMed 21788632Omboni S, Caserini M, Coronetti C. Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. High Blood Press Cardiovasc Prev. 2016 Sep;23(3):187-96. doi: 10.1007/s40292-016-0143-6. Epub 2016 Apr 12.
PubMed 27072129Omboni S, Gazzola T, Carabelli G, Parati G. Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. J Hypertens. 2013 Mar;31(3):455-67; discussion 467-8. doi: 10.1097/HJH.0b013e32835ca8dd.
PubMed 23299557Quinn CC, Gruber-Baldini AL, Shardell M, Weed K, Clough SS, Peeples M, Terrin M, Bronich-Hall L, Barr E, Lender D. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials. 2009 Jul;30(4):334-46. doi: 10.1016/j.cct.2009.02.004. Epub 2009 Feb 27.
PubMed 19250979Quinn CC, Sareh PL, Shardell ML, Terrin ML, Barr EA, Gruber-Baldini AL. Mobile Diabetes Intervention for Glycemic Control: Impact on Physician Prescribing. J Diabetes Sci Technol. 2014 Mar;8(2):362-370. doi: 10.1177/1932296813514503. Epub 2014 Feb 5.
PubMed 24876589Quinn CC, Shardell MD, Terrin ML, Barr EA, Park D, Shaikh F, Guralnik JM, Gruber-Baldini AL. Mobile Diabetes Intervention for Glycemic Control in 45- to 64-Year-Old Persons With Type 2 Diabetes. J Appl Gerontol. 2016 Feb;35(2):227-43. doi: 10.1177/0733464814542611. Epub 2014 Aug 6.
PubMed 25098253Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Pawloski PA, Sperl-Hillen JM, Trower NK, Tucker AD, Green BB. A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work? J Gen Intern Med. 2015 Nov;30(11):1665-72. doi: 10.1007/s11606-015-3355-x.
PubMed 25952653
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02919033
- Acronym / sponsor ID
- SHDC12015308
- Conditions
- Hypertension
- Keywords
- randomized controlled trial, telemedicine, hypertension, primary care, medication adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Xu LeiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- 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 three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.
Detailed description
Background: Hypertension is a major risk factor for cardiovascular diseases and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCP) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-Cardiologist model that applies telemedicine tools to facilitate community hypertension control in China.
Methods/Design: Hypertensive patients receiving care at four community healthcare centers (CHCs) that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have uncontrolled blood pressure in the previous three months and access to mobile internet. Study subjects are randomly assigned to three interventional groups: 1) usual care; 2) home-based BP tele-monitor with embedded GSM module and unlimited data plan, an App to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or 3) this plus coordinated PCP-Cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure (SBP) over a 12-month period. Secondary outcomes are changes of diastolic blood pressure (DBP), HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale MMAS.
Discussion: This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model (PCTM) that incorporates the lasted telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of uncontrolled hypertensive patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care (UC) | Placebo comparator | Other: Usual carePatients are managed by their PCPs at the registered CHCs as usual. |
| Self-management | Experimental | Device: Self-management* BP tele-monitor \& App based self-management supports * Patient proficiency training |
| PCTM intervention | Experimental | Other: PCTM intervention* BP tele-monitor \& App-based self-management supports * Patient proficiency training * PCP \& cardiologist training of using Web-based analytics * Proactive and interactive care by PCPs and cardiologists |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 21 years or older
- a clinical diagnosis of hypertension with uncontrolled BP in the previous three months, currently taking or about to take anti-hypertensive medications
- received high school or above level of education
- active user of smart phone (Android or Apple) and mobile Apps
- the average of three BP measurements during the screening visit at the CHC is ≥ 140/90 mm Hg, or ≥ 130/80 mm Hg if the patient has diabetes or renal diseases;
Key exclusion criteria (9 listed)
- acute coronary syndrome
- heart failure
- cardiac arrhythmia
- stroke within the past three months
- renal failure
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 |
|---|---|---|
| Usual careThe hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients. | Other | Usual care (UC) |
| Self-management* Usual care * Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging. * All patients receive proficiency training in using the BP tele-monitor, and mobile App. | Device | Self-management |
| PCTM intervention* Usual care * Self-management * PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs. * PCPs and cardiologists receive training of the CareLinker website. | Other | PCTM intervention |
Primary outcome
Changes in mean SBP
Time frame: From baseline (T1) to 12 months (T3)
The primary endpoint of the trial is changes in mean SBP from baseline (T1) to 12 months (T3) measured using the BP tele-monitor (Bliss BL928). The 12 months BP readings will be determined by taking the average of three BP measurements at the follow-up visit to the CHC. All BP data are collected and uploaded simultaneously to the trial database.
3 secondary outcomes
Changes in mean DBP
Time frame: From baseline (T1) to 12 months (T3)
Hypertension control rate
Time frame: From baseline (T1) to 6 months (T2) and 12 months (T3)
Anti-hypertensive medication adherence
Time frame: At baseline (T1) and 12 months (T3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Background: PubMed 23746901Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, Vos T, Wang H, Lopez AD, Murray CJ. Rapid health transition in China, 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Jun 8;381(9882):1987-2015. doi: 10.1016/S0140-6736(13)61097-1.
- Background: PubMed 19454737Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009 May 19;338:b1665. doi: 10.1136/bmj.b1665.
- Background: PubMed 16508562Dickinson HO, Mason JM, Nicolson DJ, Campbell F, Beyer FR, Cook JV, Williams B, Ford GA. Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials. J Hypertens. 2006 Feb;24(2):215-33. doi: 10.1097/01.hjh.0000199800.72563.26.
- Background: PubMed 25131978Blood Pressure Lowering Treatment Trialists' Collaboration. Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data. Lancet. 2014 Aug 16;384(9943):591-598. doi: 10.1016/S0140-6736(14)61212-5.
- Background: PubMed 25660364Kumar N, Khunger M, Gupta A, Garg N. A content analysis of smartphone-based applications for hypertension management. J Am Soc Hypertens. 2015 Feb;9(2):130-6. doi: 10.1016/j.jash.2014.12.001. Epub 2014 Dec 11.
- Background: PubMed 18473689Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008 Jun;10(3):160-8. doi: 10.1089/dia.2008.0283.
- Background: PubMed 26490012Pfaeffli Dale L, Whittaker R, Jiang Y, Stewart R, Rolleston A, Maddison R. Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial. J Med Internet Res. 2015 Oct 21;17(10):e237. doi: 10.2196/jmir.4944.
- Background: PubMed 26512667Fernandez-Granero MA, Sanchez-Morillo D, Leon-Jimenez A. Computerised Analysis of Telemonitored Respiratory Sounds for Predicting Acute Exacerbations of COPD. Sensors (Basel). 2015 Oct 23;15(10):26978-96. doi: 10.3390/s151026978.
- Background: PubMed 21788632Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. doi: 10.2337/dc11-0366. Epub 2011 Jul 25.
- Background: PubMed 27072129Omboni S, Caserini M, Coronetti C. Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. High Blood Press Cardiovasc Prev. 2016 Sep;23(3):187-96. doi: 10.1007/s40292-016-0143-6. Epub 2016 Apr 12.
- Background: PubMed 23299557Omboni S, Gazzola T, Carabelli G, Parati G. Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. J Hypertens. 2013 Mar;31(3):455-67; discussion 467-8. doi: 10.1097/HJH.0b013e32835ca8dd.
- Background: PubMed 19250979Quinn CC, Gruber-Baldini AL, Shardell M, Weed K, Clough SS, Peeples M, Terrin M, Bronich-Hall L, Barr E, Lender D. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials. 2009 Jul;30(4):334-46. doi: 10.1016/j.cct.2009.02.004. Epub 2009 Feb 27.
- 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.
Lei Xu, Master principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management and PCTM intervention in people with Hypertension, run by Xu Lei 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 6 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 29 Sep 2016. 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. Some participants in this study may receive a placebo. 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 Lei Xu, Master (86-21-32260806, waqyl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean SBP (time frame: From baseline (T1) to 12 months (T3)). 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 NCT02919033, which also lists 52 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 29 Sep 2016.