GRAND Study: an observational study on home blood pressure monitoring in India
Not Applicable
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2023/02/049486
- Lead Sponsor
- OMRON HEALTHCARE Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients living in India.
2. Patients diagnosed with hypertension and on stable hypertension medication > 3 months.
3. Patients who are thoroughly informed about the study and signed an informed consent form.
Exclusion Criteria
1. Patients with Pregnancy-Induced Hypertension.
2. Shift workers or patients working for odd hours (working between 5 pm and 9 am).
3. Patients with arm circumference of < 22 cm or > 42 cm.
4. Patients deemed unfit to participate in the study due to a health condition.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of patients based on BP control status by the difference in the clinic and home BP thresholds into 4 categories: white-coat hypertension, masked hypertension, well-controlled hypertension, and sustainable uncontrolled hypertension. The BP control status will also be investigated by regions and expressed with graphical bars.Timepoint: At the end of data collection completion.
- Secondary Outcome Measures
Name Time Method Secondary outcomes / Clinical <br/ ><br>â?¢To find out the correlation of demographic, anthropometric, socioeconomic, medical condition, medication use, and lifestyle factors to BP control status and HR, including data collected from unique demographics in India. <br/ ><br>â?¢To examine BP and HR variability for visit-to-visit CBP, day-by-day HBP, morning HBP, and evening HBP. <br/ ><br>â?¢Comparison between the digitally recorded BP measurement and manually recorded. <br/ ><br>Secondary outcomes / Behavioural <br/ ><br>â?¢To investigate the knowledge, attitude and practice (KAP) of HBPM by hypertensive patients in India. <br/ ><br>â?¢Determine the association between KAP, physiciansâ?? instructions of HBPM and prescription usage to BP control among hypertensive patients. <br/ ><br>â?¢To investigate the change in patientâ??s KAP regarding HBP from visit1 patient Home BP survey and visit 2 feedback survey.ã?? <br/ ><br>Timepoint: At the end of data collection completion.