Hypertension
Conditions
Brief summary
The clinical trial aims to evaluate whether a community and primary care-based intervention linked with mobile technology (CoPILOT) is acceptable, effective, cost-effective, sustainable, and scalable in improving hypertension (HTN) control among individuals aged 30 to 70 in Nepal. The primary research questions include: Is the use of the application by Frontline Health Workers (FLHWs) and Female Community Health Volunteers (FCHVs) feasible and acceptable? Can FCHVs equipped with mHealth technology effectively increase the linkage of individuals with elevated blood pressure (BP) to health facilities? Does a mobile-based lifestyle intervention reduce or control BP? Can adherence to prescribed HTN treatments be improved among patients through this intervention?
Detailed description
The researcher will compare the intervention and control groups to assess changes in BP, quality of life (QoL), body mass index (BMI), medication adherence, and linkage to care. Participants in the intervention group will: Attend bi-monthly meetings conducted by FCHVs for BP measurement, facilitated through the mobile application. Receive healthy lifestyle awareness guidance provided by FCHVs via the mobile app and supplemented with text message reminders. Visit nearby health facilities for monthly follow up.
Interventions
OTHERFCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology
Our intervention utilizes FCHVs as a bridge between the community and health facilities to improve HTN care. FCHVs and FLHWs will receive 2 days of training to use an Android app. The app provides prompts for BP measurement and educational content on healthy lifestyles. For 3 months, FCHVs will conduct bimonthly meetings, measure BP, height, and weight, provide awareness and enter sociodemographic details of participants into the app. Participants with BP ≥130/85 mmHg (unmedicated) or ≥120/80 mmHg (on medication) will be referred to a nearby health facility by FCHVs. The data entered by FCHVs will be linked to FLHWs' terminals. FLHWs will enter required information about medication use, referrals, and follow-ups into the app and take necessary actions for the treatment of referred patients. The intervention includes 795 participants from 10 clusters with BP ≥130/85 mmHg. Data on BP, medication adherence, quality of life, and physical activity will be collected at baseline and endline.
Sponsors
Dhulikhel Hospital
Duke Kunshan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Hypertensive patient's should be in the range of 30 to 70 years old living in selected communities with HTN (systolic BP ≥ 130 mmHg or diastolic ≥ 85 mmHg or taking antihypertensive medication) * They should have been diagnosed previously and under medication. * They should agree to the informed consent * FCHVs should be working for the selected communities and agree to the informed consent * FLHWs should work for the health facilities in selected communities and agree to the informed consent.
Exclusion criteria
* Participants who are not able to respond during the data collection period. * Participants who are out of municipality during the data collection period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure (mmHg) | Three months intervention | Change in systolic and diastolic blood pressure (mmHg) among hypertensive patients in the intervention group will be measured using a validated digital blood pressure monitor at baseline and endline. The outcome will be reported as the mean change in systolic and diastolic blood pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index (BMI) (kg/m²) | Three months intervention period | Body Mass Index (BMI) will be calculated using the formula BMI = weight (kg) / height² (m²). The BMI values will be derived from the collected data and analyzed to assess changes. |
| Change in body weight(kg) | During baseline and endline (3 months intervention period) | Weight will be measured in kilograms using a weighing scale at health posts by healthcare providers or by FCHVs during group meetings. The measurements will be recorded in the application and later analyzed to assess changes in body weight. |
| Height (meters) | At baseline or endline (3 months intervention period) | FLHWs will measure the height (in meters) by using stadiometer at health posts. They will enter the data in the application. |
| Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS) | Three months intervention period | Quality of life will be assessed using the EuroQol Visual Analogue Scale (EQ VAS), administered by the study team at baseline and endline. Participants will rate their overall health on a vertical visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), and changes in these scores will be used to evaluate improvements in health-related quality of life. |
| Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS) | Three months intervention period | Medication adherence will be assessed using the Morisky Green Levine Medication Adherence Scale (MGLS), administered by the study team at baseline and endline. The MGLS is a 4-item self-report scale that assesses medication-taking behavior, with each item scored 1 for No and 0 for Yes. Total scores range from 0 to 4, with higher scores indicating better adherence. The outcome will be reported as the change in MGLS total score over the 3-month intervention period. |
| Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews | Three months intervention period | Empowerment will be assessed through qualitative semi-structured interviews conducted with FCHVs and FLHWs at both baseline and endline. Interview questions will explore changes in core dimensions of empowerment, including knowledge, confidence, and role perception, in relation to the hypertension mHealth intervention. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. The outcome will be reported as a summary of key themes and illustrative quotes that reflect perceived changes in empowerment over the 3-month intervention period. |
Countries
Nepal
Contacts
Primary ContactLijing Prof. Lijing Yan
Backup ContactDr. Abha Shrestha
Outcome results
None listed