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Heart’s Intervention Design Targeting Younger Adults & Ageing Population (HRIDAYA)

Co-Designing a Multi-level Intervention for the diagnosis, treatment and long-term care of hypertension and diabetes in three diverse cities in Nepal: Impact of the Heart’s Intervention Design Targeting Younger Adults & Ageing Population (HRIDAYA).

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000128392
Acronym
HRIDAYA
Enrollment
2050
Registered
2026-01-30
Start date
2026-02-02
Completion date
2026-04-30
Last updated
2026-02-09

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

Conditions

None listed

Brief summary

HRIDAYA is a pragmatic hybrid 2 implementation study comprising a multi-level evidence-based co-designed intervention specifically aimed to improve the continuum of care for NCDs in Nepal. The intervention is aimed at improving the current fragmentation in the primary health care and community settings through a series of interventions: i) community system strengthening by enhancing the capacity of CHWs to screen for risk factors and refer at-risk patients with support from a mobile-based application; ii) develop, expand and extend an enhanced model of care to augment health professional’s capacity for managing hypertension and diabetes across the municipalities; iii) establish a mechanism to integrate the community system with the primary health care system to improve the continuum of care for hypertension and diabetes; and iv) co-design and modify an existing system-base intervention to optimise monitoring and tracking of people with hypertension and diabetes.

Interventions

Health facility-level intervention 1. Training of primary health care workers on a package of essential non-communicable diseases (PEN) to improve diagnosis and initiation of blood pressure and diabetes medication 2. Training of health workers on the HRIDAYA mobile App 3. Female community health volunteers (FCHVs) and the health facility extended meeting to discuss tracking and follow-up. 4. Weekly visit tracking by the trained health workers Community-level intervention 5. Training FCHVs

Health facility-level intervention 1. Training of primary health care workers on a package of essential non-communicable diseases (PEN) to improve diagnosis and initiation of blood pressure and diabetes medication 2. Training of health workers on the HRIDAYA mobile App 3. Female community health volunteers (FCHVs) and the health facility extended meeting to discuss tracking and follow-up. 4. Weekly visit tracking by the trained health workers Community-level intervention 5. Training FCHVs on hypertension monitoring, non-communicable diseases (NCD) risk factors and lifestyle counselling 6. Distribution of digital blood pressure monitors for ongoing blood pressure monitoring 7. Training of FCHVs on HRIDAYA mobile App 8. IVR messaging for follow-up for confirmatory test at two weeks of screening 9. Phone follow-up by FCHVs three weeks after screening for the confirmatory test. 10. Mobile app for the FCHVs for clinical decision support and monitoring of NCD risk factors and blood pressure recording 11. Quarterly home visit by FCHV and lifestyle counselling, measurement and monitoring of blood pressure, review of medication adherence and adherence counselling and referral for those with uncontrolled blood pressure 12. App-based IVR 1 week following the first and third FCHV home-visit 1. Training of primary health care workers on package for essential non-communicable diseases (PEN) to improve diagnosis and initiation of blood pressure and diabetes medication: Training of primary health care workers on package for essential non-communicable diseases (PEN) to improve diagnosis and initiation of blood pressure and diabetes medication: Those primary health care workers currently working in the health posts and primary healthcare centres will be provided with a four-day consecutive standard training on PEN. The training will be facilitated by PEN-accredited trainers (Certified Medical doctors with a minimum of MBBS) through in-person lectures and practical sessions using the Government of Nepal training module. In addition, the last day of the training will be focused on the process for measuring blood pressure at the screening camps. All the PEN trainings will be completed before two months of actual careening. An additional half-day in-person training after two months of four-day standard training, or two weeks prior to actual screening camps will be provided by Nepal Development Society Project Officers for the primary health care workers on the use of the HRIDAYA mobile App. After the training, health workers will be mobilised in coordination with the municipal health section to undertake screening sessions at the individual wards. 2. Training of health workers on the HRIDAYA app HRIDAYA App will be used to collect data at baseline, and 12 months follow-up and 24 months follow-up. The HRIDAYA App is an mobile App developed in the Commcare platform that will collect and store deidentified data on the participants sociodemographic information, behavioural information, data on blood pressure and blood glucose measurements. The App will support Female Community Health Volunteers (FCHVs) for clinical decision-making and referral at the health facilities during household visit. Further the app will also send interactive voice recording (IVR) for reminding participants to visit health facilities. Health workers will track participants visit at health facility through the HRIDAYA App. Half-day (consecutive 4 hours) in-person training will be provided to health professionals after two months of four-day standard training, and two weeks prior to actual screening camps for tracking and monitoring participants' visits to health facilities using HRIDAYA App. 3. FCHVs and the health facility extended the meeting to discuss tracking and follow-up Currently monthly meeting of primary health care workers and FCHVs (usually 1.5 hours) are undertaken for reporting on maternal and child health. This meeting will be extended by another half an hour for targeted discussion on the follow-up, tracking and monthly target setting for hypertension and diabetes cases. The extended meeting will be undertaken for 24 months in the intervention cluster. 4. Weekly visit tracking by the trained health workers The primary health care workers will use the mobile App to track referral and visit of participants to health facility. The standard training to health workers and female community health workers will be conducted only once during the 24 months intervention. However, on-day review and refresher training (eight hours) will be provided to both health professionals and community health workers after 12 months of intervention. Separate attendance sheets will be developed for each of the training and refresher trainings. Participants are only refunded the travel cost once they complete the entire training. Meeting minutes with participants signature will be also maintained at the health facility. Further, weekly visit tracking will be monitored through HRIDAYA mobile App. Community-level intervention 5. Training FCHVs on hypertension monitoring, NCD risk factors and lifestyle counselling FCHVs are the lowest unit of the health care system in Nepal. They are minimally trained lay health providers. Nepal has a wide network of more than 52,000 female community health workers who are assigned the responsibility of community-based health services, including community outreach for immunisation, health education and supply of family planning commodities. Before two-months of screening of participants, all FCHVs with a minimum of secondary education will be invited to a five-day in-person training, including didactic lectures covering non-communicable diseases with a focus on hypertension and diabetes. The training is divided into two categories. The first four-day standard training will be consecutive training and comprise practical sessions for blood pressure measurement with digital devices, motivational interviewing, use of the referral checklist and logistics program. The training will be facilitated by a physician, the project coordinator, resource persons (the health coordinators, health sector senior staff, and Nepal Development Society staff), and the data manager. On the fourth day of the training, CHWs will undergo an evaluation process to assess their knowledge and skills in blood pressure measurement, lifestyle counselling, and referral procedures to health facilities. FCHVs who score above 85% will be certified and authorised to participate in the HRIDAYA ongoing management during the intervention phase. They will also receive a certificate of completion. FCHVs who score less than 85% will be asked to assist their nearest certified FCHVs in disseminating information about the screening camps but will not be engaged in the ongoing monitoring. All the standard training will be completed two months prior to actual intervention. All participants will be awarded a certificate of participation in the training. Those participants who scored above 85% in the standard training will be invited for one day training on data collection using the HRIDAYA mobile application and decision-support system. The one-day training on the HRIDAYA mobile APP will be undertaken two weeks before the screening camps. Other existing FCHVs without secondary educational qualifications or who did not score 85% or above will be provided a one-day orientation about the HRIDAYA program two weeks before the screening camps and will be mobilised to assist during the camps but will not participate in the in-person ongoing monitoring. Paper-based attendance sheet will be maintained for each training including FCHV training and the participants will only be reimbursed for travel after completion of training or orientation to maintain adherence. 6. Distribution of BP sets for blood pressure monitoring Those FCHVs with at least secondary level education and completed the FCHV training will be provided with OMRON BP monitors for ongoing monitoring during household visit. 7. Training of FCHVs on HRIDAYA App The FCHVs will be trained to use and record on HRIDAYA App during their household visit. The HRDAYA app would enable better decision support for blood pressure monitoring and referral. The last day of the FCHV training will focus on the use of HRIDAYA app. One day training will only be provided to those FCHVs who complete four-day standard training and score more than 85%. The App training will be provided two weeks before the actual screening. 8. Interactive voice response (IVR) messaging for follow-up for confirmatory test at two weeks of screening IVR messages will be sent to the participants two weeks after the screening to all participants to remind them of their confirmatory tests. All participants will receive an automated call to inquire if they visited for the confirmatory tests and to reinforce the need to visit health facility for confirmatory tests. 9. Phone follow-up by FCHVs three weeks after screening for the confirmatory test. For those not responding to the IVR and those responding that they have not visited the health facility for the confirmatory tests, FCHVs will follow-up via phone call and encourage them to go for a confirmatory test. 10. Mobile app for the FCHVs for clinical decision support and monitoring of NCD risk factors and blood pressure recording Research Assistants will provide access to HRIDAYA mobile App to FCHVs which will enable them to record NCD risk factors and blood pressure measurements. 11. Quarterly home visit by FCHV and lifestyle counselling, measurement and monitoring of blood pressure, review of medication adherence and adherence counselling and referral for those with uncontrolled BP. Data will be monitored every week by our Project Officers at NeDS to ensure the FCHV visits and ensure data reporting and quality. Project Officers will also have a biweekly data review with FCHVs and field observations (monthly). The trained FCHVs will visit participants in the intervention wards every four months where they will be providing lifestyle counselling and blood pressure monitoring. They will use HRIDAYA app to support decision making and refer those with uncontrolled blood pressure. 12. App-based IVR 1 week following the first and third FCHV home-visit After a week of first and third FCHV visit, an automated IVR will be sent to assess participants response on the recent FCHV household visit. The community-based interventions will be provided for 12 months in the intervention clusters and expand to usual care clusters for another 12 months. Therefore, participants in the intervention clusters will receive 24 months of intervention and those in usual care cluster will receive 12 months of intervention from 12-24 months. To select and adapt HRIDAYA intervention components to the local municipal context, several formative research activities were conducted during the first phase of the study, including a rapid health facility assessment using the Service Availability and Readiness Assessment, in-depth interviews, and co-design workshops. This was facilitated through the formation of technical and consumer advisory committees at each municipality. The technical advisory committees each comprise two local policy makers (i.e., mayor, deputy mayor, or other local leaders), one municipality health focal person, two primary-level healthcare workers on rotation, three Female Community Health Volunteers (FCHVs) on a rotation basis, three ward chairs on a rotation basis, one registered pharmacist, one member of the consumer advisory committee, and two members from Nepal Development Society (NeDS). The members from the wards shall be nominated in consultation with elected representatives. The composition is flexible, allowing the addition or reduction of members as the project evolves and new needs arise. The consumer advisory committees include nine to twelve individuals living with either hypertension or diabetes, or both, within each municipality. The advisory committee were established to have will have proportionate representation from nearer and farther wards (distance from hospitals), those from disadvantaged ethnicities, and men and women. The technical and consumer advisory committee will be engaged at each stage to ensure their perspectives, knowledge and input are included in all stages of research. In the formative research, we aim to identify the current gaps in the continuum of care for hypertension and diabetes; identify potential barriers and enablers for improving diagnosis, treatment and long-term care for hypertension and diabetes; and co-develop HRIDAYA interventions through in-depth interviews with people living with hypertension and focus group discussion with FCHVs. Further key informant interviews were undertaken with primary health care providers and policy makers. Guided by the updated Consolidated Framework for Implementation Research (CFIR), main implementation barriers and facilitators will be mapped to proposed intervention components and implementation strategies. Codesign workshops: The codesign workshop was undertaken with those participating in the interviews and focus group discussion to identify and finalise set of interventions for the HRIDAYA project. One day implementation workshop was undertaken in each of the three participating municipalities. Participants from the in-depth interviews were invited to the co-design workshop, In the co-design workshops where barriers and facilitators were mapped to Capability, Opportunity, motivation and Behaviour (COM-B) framework and priorities were identified. The codesign workshop enabled adaptation of and existing systems of care for diagnosis and management of hypertension and diabetes. The workshops were undertaken four months before the actual intervention delivery. This enabled enough time for planning and refining the codesigned intervention strategies.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
30 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

• Age 30 to 69 years, and a permanent resident of the implementing municipalities (Changunarayan, Kageshwori Manohara and Madhyanepal) • Meeting at least one of the following conditions: -Hypertension: defined as blood pressure greater than and equal to 130/90 mmHg at screening and confirmatory tests -Type 2 diabetes: defined as fasting glucose greater than or equal to 126 mg/dl at camp and HbA1c% greater than or equal to 6.5 at the follow-up visit

Exclusion criteria

• Blood pressure greater than or equal to180/120 mmHg • Blood glucose greater than or equal to 400 mg/dl • Diagnosed with secondary hypertension by health professionals • Diagnosed with other diabetes other than type 2 by health professionals • Currently taking anti-hypertensive medications • Currently taking anti-diabetic medication • Presenting with acute symptoms that may require hospitalizations, which include but not limited to: -Nausea, vomiting, diarrhea -Abdominal pain -Loss of motor or sensory function -Altered mental status -Chest pain, chest tightness -Dyspnea, shortness of breath -Fever • Diagnosed with terminal illness by a health professional, defined as a life expectancy of 6 months or less. • Individuals that are mentally compromised and unable to give informed consent • Currently pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026