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Study to evaluate the efficacy of mobile health application Phablecare in Indian adults with uncontrolled hypertension

Efficacy of digital therapeutic intervention via MAP (Mobile health Application Phablecare) in Indian adults with Uncontrolled Hypertension: A 12-week prospective single arm study. - MAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038779
Enrollment
125
Registered
2021-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: patients own data from baseline visit: patients own data before using the app at baseline will be compared with the data post 3 months of app usage.

Sponsors

Terrals Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients aged � 30 to 65 years. 2.Able to give written informed consent. 3.Diagnosed and under treatment cases of Primary Hypertension, with Blood Pressure levels either > 140 mmHg systolic or > 90 mmHg diastolic. 4.Grades of Hypertension: Grade 1, 2, and 3(ESC/EHS Guidelines). 5.Owning a smart phone and the ability to use it, sufficient literacy, aspiration to participate in the trial. 6.With or without other comorbidities such as coronary heart disease, diabetes, hyperlipidaemia etc

Exclusion criteria

Exclusion criteria: 1.Patients associated with any other Hypertension/Chronic Disease intervention program via digital therapeutic channels. 2.Illiteracy and no ability to use smart phone. 3.Bedridden and/or severely compromised patients (Chronic kidney disease, HIV, post-surgery, Covid, severe cardio pulmonary disorders etc.) 4.Pre and post-partum women. 5.Handicap restricting physical movements. 6.Patients who received previous such digital therapeutic intervention.

Design outcomes

Primary

MeasureTime frame
1.Percentage change in mean systolic & diastolic BP levels as recorded through MAP (Day 1 & Day 90). 2. Improvement in treatment compliance. (Day 1 & Day 90 via Part A of Questionnaire). 3. Increase in self-monitoring of own health condition (amount of data shared on app, as per the protocol schedule assessed via data on google sheets). (Day 1 & Day 90). 4. Subjective perception of the patient with respect to hypertension awareness, management of blood pressure (medical/non-medical), diet & exercise, prevention of complications, etc., as derived from pre & post questionnaire (Part B). Timepoint: Day 1 and Day 90

Secondary

MeasureTime frame
1.Consultation and Patient load management by the Principal Investigator ââ?¬â?? Incremental Time spent by the physician per patient during typical clinical intervention period (Total time spent by the physician on a patient in routine clinical visits against Sum of physician consultation time (Apart from screening if needed) plus time spent on mobile app for remote health management) via PI feedback questionnaire. 2. Change in ongoing oral anti-hypertensive medicines (Day 1 to Day 90). 3. Change in lipid levels (Total cholesterol, HDL, LDL) (Day 1 & Day 90). Timepoint: Day 1 and Day 90

Countries

India

Contacts

Public ContactMr Sohal Pendse

ProRelix Services LLP

sthasma@prorelixresearch.com8124806366

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026