Simplified regimen for better blood pressure control with tele-medicine and home blood pressure monitoring: a multicenter, open-label, randomized trial

SimplifIed regiMen for better blood Pressure controL with tele-mEdicine and home blood pressure monitoring (SIMPLE): a multicenter, open-label, randomized trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037217

Enrollment

Unknown

Registered

2020-08-27

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

simplified regimen with tele-medicine and home blood pressure monitoring group:The patients will use a fingerprint-recognized home blood pressure monitoring to automatically upload blood pressure, and

control group:Routine blood pressure clinic visit

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 and 75 years; 2. Primary hypertension under medical treatment with uncontrolled blood pressure (SBP > 140 mm Hg or DBP > 90 mm Hg); 3. Willing to participate the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Office SBP > 180 mm Hg or DBP > 100 mm Hg; 2. Secondary hypertension; 3. Taking over three different antihypertensive agents; 4. Atrial fibrillation or arrhythmia making oscillometric BP measurement unreliable; 5. Any diagnosed Type I or II diabetes, renal dysfunction (eGFR of less than 30 mL/min/1.73m2 at screening using the MDRD formula), coronary heart disease, heart failure or a past history of stroke or myocardial infarction; 6. Any serious medical condition; 7. Participation in any other trial; 8. Amnesia or dementia; 9. Diagnosed with severe valvular heart disease; 10. Spouse already participated in the study; 11. Not own a mobile phone for remote communication; 12. Conditions determined unfit for the study by investigators.

Design outcomes

Primary

Measure	Time frame
change in office SBP at baseline and 6-month follow-up;	—

Secondary

Measure	Time frame
change in office DBP at baseline and 6-month follow-up;change in office SBP and DBP at baseline and 3-month follow-up;blood pressure compliance rate at 3-month/6-month follow-up;accuracy of patients’ BP diary compared to uploaded BP;the assessment of drug adherence;treatment expectation;disease awareness;lifestyle (drinking, diet, exercise, smoking);the assessment of quality of life;	—

Countries

China

Contacts

Public ContactYi Zhang

Shanghai Tenth People's Hospital

yizshcn@gmail.com+86 21 66308182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026