An interventional study of FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology in Hypertension, sponsored by Duke Kunshan University. Not yet recruiting at 1 site in Nepal. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Duke Kunshan University · Not applicable, Interventional, and Prevention
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?
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 520 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Duke Kunshan University is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FCHVs and FLHWs will be given 2 days training on Android mobile-based application usage. The app includes prompts regarding patients' current BP measurements and educational content on dietary habits, the importance of physical activity, and the harmful effects of smoking and alcohol consumption. FCHVs will conduct bimonthly meetings with groups of hypertensive patients. They will measure BP, enter it in the app, provide awareness and refer to nearby health facilities if needed. Data entered by FCHVs will be synchronized with FLHWs' accounts, allowing them to view the data entered by FCHVs. After a patient visits a health facility, the FLHW will take action as needed and record it in the app, thereby creating a linkage between the community and the health facility. Patients registered in the app will also receive weekly health education text messages on their mobile phones.
Other: FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology
Usual care refers to the standard treatment that participants receive as part of their regular routine, without the research introducing any new interventions. The FCHVs and FLHWs in the usual care group will not receive training on application usage, and the participants will not receive text messages on their mobile phones.
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.
Change in blood pressure (mmHg)
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.
Time frame: Three months intervention
Change in body weight(kg)
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.
Time frame: During baseline and endline (3 months intervention period)
Height (meters)
FLHWs will measure the height (in meters) by using stadiometer at health posts. They will enter the data in the application.
Time frame: At baseline or endline (3 months intervention period)
Change in body mass index (BMI) (kg/m²)
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.
Time frame: Three months intervention period
Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS)
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.
Time frame: Three months intervention period
Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS)
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.
Time frame: Three months intervention period
Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews
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.
Time frame: Three months intervention period
Plan to share: No
Start is estimated for Aug 2025; primary completion for Oct 2025, 2 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 2 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Duke Kunshan University