F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.163362.1 Study Protocol Articles Acceptability and Scalability of an IT-based App for Risk Assessment of Non-Communicable Diseases by Lady Health Workers in Pakistan – Study Protocol for a Mixed Method Pilot Trial

[version 1; peer review: awaiting peer review]

 Jarrar Zeerak Conceptualization Data Curation Formal Analysis Funding Acquisition Investigation Methodology Project Administration Resources Software Supervision Validation Visualization Writing – Original Draft Preparation Writing – Review & Editing https://orcid.org/0000-0002-1530-8011 a 1 Sattar Saadia Data Curation Formal Analysis Investigation Methodology Project Administration 1 Usman Shaharyar Data Curation Investigation Project Administration https://orcid.org/0009-0000-8247-9091 1 Rind Ghulam Kubra Data Curation Investigation Project Administration 1 Naqvi Hassan Z. Data Curation Project Administration Resources Software 2 Yan Lijing L. Conceptualization Methodology Supervision Writing – Original Draft Preparation Writing – Review & Editing 3 Samad Zainab Funding Acquisition Methodology Supervision Writing – Review & Editing 4 Kamal Ayeesha Kamran Conceptualization Investigation Methodology Supervision Writing – Original Draft Preparation Writing – Review & Editing 5 Medicine, The Aga Khan University, Karachi, Sindh, 74800, Pakistan Institute for Global Health and Development, The Aga Khan University, Karachi, Sindh, 74800, Pakistan Global Health Research Center, Duke Kunshan University, Kunshan, Jiangsu, 215316, China Section of Cardiology, Department of Medicine, The Aga Khan University, Karachi, Sindh, 74800, Pakistan Section of Neurology, Department of Medicine, The Aga Khan University, Karachi, Sindh, 74800, Pakistan zeerak.jarrar@aku.edu

No competing interests were disclosed.

 5 6 2025 2025 14 560 9 5 2025 Copyright: © 2025 Jarrar Z et al. 2025 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The prevalence of non-communicable diseases (NCDs) is rising globally, especially in lower-middle-income countries, underscoring the need for effective public health interventions. There is limited evidence that mobile health interventions can assist in identifying the risk of NCDs in the community. Leveraging existing grassroots infrastructure, such as the Lady Health Worker (LHW) program, presents a promising opportunity to address this challenge. We developed a mHealth application to address this issue. This study protocol describes the design of a pilot study aimed at developing a mHealth application, assessing the feasibility, acceptability (barriers and facilitators), and usability to triage the risk of NCDs and pilot test it in the hands of the LHWs in Pakistan.

This study consists of three phases. In phase 1, we develop a comprehensive mHealth application incorporating validated tools for NCD assessment, including the Rose Angina Questionnaire, Questionnaire for Verifying Stroke-free Status, Risk Assessment of Pakistani Individuals for Diabetes, Global Adult Tobacco Survey, International Physical Activity Questionnaire, Refined Food Frequency Questionnaire, and WHO 5 Wellness Index. Phase 2 involves qualitative focus group discussions with LHWs to refine the prototype. Phase 3 entails piloting the application with a sample of 30 LHWs in Karachi and Hyderabad, followed by qualitative exit feedback from LHWs, supervisors, healthcare providers, and community members. The outcomes will be analyzed by means, standard deviation or median with interquartile range for continuous data based on the normality assumption. The frequency with percentages will be registered for the categorical variables to describe the risk identifiers using the NCD tool kit. Internal consistency as validity evidence of the assessment can be determined using Cronbach’s alpha and the content validation index. If deemed feasible or acceptable, our mHealth app will address gaps in the literature and advance NCD research by identifying and improving the quality of life of people in the community in developing countries like Pakistan. The functioning and dissemination of this MHealth application can be an essential step towards highly scalable NCD data collection for a population at high risk for developing NCDs.

 Non-communicable Disease; Community Health Worker; Mobile Application MHealth Applications Digital Health Lady Health Workers (LHWS) National Institutes of Health D43TW011625 The research reported in this publication was supported by the Fogarty International Center (FIC) of the National Institutes of Health (NIH) under Award Number D43TW011625. Zeerak Jarrar reports working as an Instructor Research and a NIH Fogarty Fellow under 5D43TW011625-03. Zainab Samad reports grants or contracts from the Bill & Melinda Gates Foundation; Fogarty International Center of the National Institutes of Health (D43TW011625); National Institute for Health and Care Research; Yale University, Duke University; Certara; and PHRI; and payment from Cytokinetics as an advisor for participation in the Heart Failure Publication Committee meeting. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Abbreviations FGDs

Focus Group Discussions

 GATS

Global Adult Tobacco Survey

 Health

Mobile Health

 HQ

Household Questionnaire

 IPAQ

International Physical Activity Questionnaire

 LHWs

Lady Healthcare Workers

 NCDs

Non-Communicable Diseases

 QVSFS

Questionnaire for Verifying Stroke-Free Status

 RAPID

Risk Assessment of Pakistani Individuals for Diabetes

 RAQ

Rose Angina Questionnaire

 RFFQ

Refined Food Frequency Questionnaire

 WHO-5

World Health Organization-Five Well-Being Index

 Introduction

Population health statistics demonstrate that the risk of non-communicable diseases (NCDs) such as stroke and myocardial infarction in lower-middle-income countries (LMICs) is gradually increasing. 1 The Global Burden of Disease statistics for NCDs from 1990 to 2019 showed that ischemic heart disease was the second highest cause of mortality in Pakistan, stroke was the third highest, and diabetes stood at eighth highest. 2 Although there is an articulated national action plan for preventing and controlling NCDs, no examples of health system studies demonstrate a practical public health approach to NCDs. 3

Countries such as Brazil and India are experimenting with the provision of NCD care by utilizing community health workers for NCDs, such as cervical and breast cancer screening, 4 oral health, 5 dementia, 6 and blood pressure. 7 Lady health workers (LHWs) in Pakistan, who are women working within communities outside established healthcare centres and facilities, will play a crucial role in this study. They will undergo formal yet limited training for their tasks. 8 Moreover, LHWs already offer healthcare in the community within a pre-existing framework, usually focusing on maternal and child healthcare. An assessment of the LHW program in Sindh conducted by the United States Agency for International Development (USAID) reports the strengths and weaknesses of this program, showing its potential, but also points out that there is very little continued education and on-the-job training and oversight. 9 Therefore, the rationale for using mobile health (mHealth) applications along with pre-validated tools is to assist in algorithmic diagnosis and provide a platform for informed and rational NCD screening and risk assessment in the hands of LHWs.

 Objective

The objectives of the study are as follows:

Design and develop a mHealth application and alpha and beta tests for face, construct, content, and predictive validity for NCD risk, incorporating the feedback of LHWs on a test application.

Understand the perceptions of LHW regarding mobile health technology in NCDs and the mHealth application through Focus Group Discussions (to what extent they find it acceptable and user-friendly, barriers, and facilitators).

After feedback and modification, pilot testing and evaluation of the mHealth application in the community in the hands of LHWs.

Materials and methods

Study design: This will be a prospective, mixed-method study. The mHealth application will be developed and tested using the pre-validated NCD screening tools. This intervention will be set up in two major cities in Pakistan: Karachi and Hyderabad. Written informed consent will be obtained from all study participants. The active recruitment period for this study will be from June 2024 - August 2024. This study will be carried out in three phases.

Phase 1: Development of mobile health application

To ensure functionality, usability, and security, an organized approach will be taken during mobile application development. Firstly, a mobile framework will be developed, which will involve questionnaires regarding NCD risk factors. The user interface of the mobile application will involve validation checks (skip patterns, scoring algorithms, and a comprehensive data dictionary), ensuring adequacy in data collection. Android Studio will be used as the integrated development environment for the final application development to make coding, debugging, and deployment easier. Java and Kotlin will be used as the main programming languages to create the application’s architecture. A lightweight SQLite database will be utilized for offline data management, which is essential in environments with erratic internet connectivity. Custom APIs built with PHP, HTML, and AJAX connected the Android app to a web-based dashboard powered by MySQL for backend operations, ensuring real-time data synchronization. Strong encryption techniques like ACS-GCM-256 for data transit and SSL certificates for safe data synchronization between devices and servers demonstrated security’s top priority.

Pre-validated NCDs tools for mobile health application:

These tools have been selected for their reliability, validity, and efficiency. They have been cross-culturally validated and adapted, translated into Urdu (the native language in Pakistan), and ethically appropriated to ensure that the research participants are not subjected to unnecessary risks or burdens. Together, these tools form a coherent set for assessing the risk of NCDs in the community, and the estimated time for administering the whole toolkit takes 15 to 20 minutes. The pre-validated tools are as follows:

The Rose Angina Questionnaire (RAQ ) 10 : The RAQ was adapted to detect ischemic heart pain (angina pectoris and myocardial infarction) for epidemiological field surveys. The rationale for its selection lies in its widespread use and validation in various settings as a tool for detecting coronary heart disease in epidemiological studies. 11– 13 The scoring criterion involves three stages: 1 (no pain), 2 (rose angina grade 1), and 3 (rose angina grade 2), with stage 3 considered severe. Seven questions determine the stage. Stage 1 indicates no pain, while stages 2 and 3 involve pain, with latter differentiated by pain occurring at an ordinary pace. The RAQ will be added to the application with the questions and relevant logic.

Questionnaire for Verifying Stroke-Free Status (QVSFS) 14 : The QVSFS has previously undergone translation and validation in Pakistan. Scores range from 0 (indicating no positive questions) to 8 (all eight optimistic questions). Subjects were classified as QVSFS-negative (free from stroke/TIA) if their total score was 0. Conversely, if any of the eight items were positive (resulting in a sum score of 1 to 8), the QVSFS was considered positive (indicating not stroke/TIA free). Any question answered as “unknown” was scored as a negative response. The QVSFS will be added to the application to assess the community’s stroke risk.

Risk Assessment of Pakistani Individuals for Diabetes (RAPID) 15 : The RAPID tool was developed in Pakistan to predict individuals at high risk of developing type 2 diabetes. This scoring system is designed for use within the population to assess their diabetes risk. It utilises four easily obtainable factors to predict those at high risk and can serve as a mass screening tool for undiagnosed type 2 diabetes in Pakistan. The risk score is determined based on age, waist circumference, and a positive family history of diabetes. Ages between 40 and 50 years are assigned 1 point, while ages more significant than 50 are assigned 3 points. A waist circumference equal to or greater than the specified cut-off point (80 cm for females and 90 cm for males) is allocated 2 points, and a positive family history of diabetes is assigned 1 point. Individuals with a score equal to or more fantastic than four are considered at risk of diabetes (54.5%). The RAPID tool will be incorporated as the first tool in the application to assess the risk in the community.

Global Adult Tobacco Survey (GATS) 16 : GATS, launched in February 2007 as a new component of the ongoing Global Tobacco Surveillance System (GTSS), is a nationally representative household survey. It is a crucial part of the WHO framework to reduce tobacco-related diseases worldwide. 17 GATS enables countries to gather data on adult tobacco use and critical control measures. The survey covers various topics, including tobacco use prevalence (both smoking and smokeless tobacco products), exposure to second-hand tobacco smoke and related policies, cessation practices, as well as knowledge, attitudes, and perceptions regarding tobacco. Additionally, it assesses exposure to media related to tobacco and its economic aspects. The GATS questionnaire consists of a household questionnaire (HQ) to be completed by one adult residing in each selected household. 16 The HQ determines whether the chosen household meets the eligibility requirements of GATS and compiles a roster of all eligible household members. From this roster, an individual is randomly chosen to complete the individual questionnaire (IQ). The IQ gathers information on background characteristics, tobacco smoking habits, smokeless tobacco use, cessation attempts, exposure to second-hand smoke, economic factors, media exposure, and knowledge, attitudes, and perceptions related to tobacco. In Pakistan, the GATS was validated in 2014. 18 We will add this tool to our application to assess the community’s tobacco consumption risk.

International Physical Activity Questionnaire (IPAQ) 19 : The IPAQ consists of four questionnaires, including long (featuring five activity domains asked independently) and short (comprising four generic items) versions suitable for telephone or self-administered methods. These questionnaires are designed to gather internationally comparable data on health-related physical activity. They aim to assess the types and intensity of physical activity and sitting time in individuals’ daily lives, providing estimates of total physical activity in MET minutes per week and the duration spent sitting. A study conducted in Pakistan utilizing the IPAQ revealed that urbanization and modernization have led to an increase in sedentary lifestyles due to reduced levels of physical activity. 20 This validated questionnaire has been translated into Urdu in Pakistan. 21 IPAQ will be added to the application to gauge the level of physical activity in an individual’s life.

Refined Food Frequency Questionnaire (RFFQ) 22 : The RFFQ is a specialized tool for assessing dietary intake, focusing on foods and beverages. It includes a frequency response section where subjects report how often each item was consumed over a specified period. Portion size information is not collected in non-quantitative FFQs. In Pakistan, a study was conducted using the FFQ to assess the dietary intake of adult females. 23 Additionally, in Saudi Arabia, an FFQ was developed to evaluate the dietary intake of obese young children. 24 The purpose for RFFQ is to assess unhealthy diet which is a direct risk factor to NCDs in the community.

WHO 5 Wellness Index 25 : The World Health Organization-Five Well-Being Index (WHO-5) is a straightforward self-reported measure of current mental well-being. It consists of five statements, which respondents rate based on a scale reflecting their experiences over the past two weeks. The total raw score, ranging from 0 to 25, is multiplied by 4 to yield the final score. A score of 0 indicates the worst imaginable well-being, while 100 signifies the best imaginable well-being. The WHO-5 is freely accessible and does not require permission to use. In Pakistan, it has been employed to evaluate the subjective well-being of patients who may necessitate further assessment for depression or other mental disorders. 26 Moreover, this tool has been pre-validated in Urdu and is available online. 27 This tool will assist us in assessing the community’s mental well-being level.

Phase 2: Focus group discussions (FGDs)

FGDs will be conducted regarding risk factors for angina, stroke, diabetes, food frequency, tobacco use, and mental health. This will be achieved based on consolidated criteria for reporting qualitative research (COREQ) checklist, and all its items will be checked when FGDs are carried out. 28 A prototype of the mobile application will also be shown to take feedback. FGDs will be conducted in the following stages ( Figure 1):

Recruitment strategy:

Diagram Illustrating the 3 phases of the study.

LHWs residing in Karachi and Hyderabad will be identified using purposive sampling to conduct FGD. For conducting the FGDs, discussions will be held with district health officers and deputy district health officers to identify rural and urban sites in the selected locations after accounting for the urban-rural disparity. This part will consist of 15 Focus Group Discussions with the LHWs. Each group will consist of at least 10-12 LHWs per FGD tentatively until thematic saturation is reached in terms of their knowledge, attitude, and perspective about using mobile applications for NCD risk assessment.

Qualitative implementation:

Each FGD will last about 40 to 60 minutes and will be moderated by a team member skilled in qualitative research. An FGD guide with probes will be developed and translated into the local language (Urdu and Sindhi). The data collected from the FGD will be transcribed, and thematic analysis will be done to identify themes that emerge from the FGD. The information gained from these FGDs will then guide us towards the modification of the mobile health application.

 Phase 3: Pilot phase

A total of 30 LHWs will be recruited for this study, with an equal distribution of 15 in Karachi and 15 in Hyderabad. These LHWs will undergo targeted training for the pilot implementation of the mHealth application. To minimize bias, the LHWs trained to use the application will not overlap with those participating in the FGDs. The pilot phase will be conducted in the following stages:

Training of lady health workers:

A 3-day training program will be carried out to equip LHWs regarding NCDs. The curriculum will include concise information on NCDs (Cardiovascular disease, Diabetes, Stroke, Mental Health, Tobacco, physical activity, and diet) and mHealth application. This will be done to enhance their capability to use the mobile application. A pre-test and post-test will be carried out consisting of two aspects. Firstly, to understand the extent of knowledge regarding NCDs prior to training and secondly towards identification of knowledge gaps. The LHWs will be provided with informative brochures that will include definitions, causes, symptoms, and prevention of NCDs. For efficient execution of activities, refresher training sessions will be scheduled at three-week intervals for the LHWs.

Pilot implementation:

After training, LHWs will conduct a pilot test within their respective communities, gathering data through the application. The mHealth tool will provide risk stratification, categorizing patients into three groups: very high risk, high risk, and moderate-low risk. Patients classified as very high risk will be referred to a Basic Health Unit (BHU) for further consultation and disease-specific screening. High-risk patients will also be referred for consultation and screening, with an additional focus on lifestyle modification. Those in the moderate-low risk group will primarily receive guidance on lifestyle changes ( Figure 2 and Figure 3).

Stages of implementation of focus group discussion. Schematic representation of the pilot phase of the study. Data collection and management procedure

The data will be meticulously collected by the LHWs, underscoring their crucial role in this process. They will directly enter the data into the mHealth application with the NCD toolkit. This comprehensive process will determine the patient’s risk, the referral pathway, and the steps for the specific patient. Data entry can be performed online and offline, ensuring smooth processing and making the application flexible and easy to use. Data accuracy, completeness, and consistency will be guaranteed through training and refresher training and an extensive verification system. Data will be downloaded into spreadsheets, ensuring a thorough and reliable data management process.

 Statistical analysis plan

Quantitative analysis: Stata version 18 will be used for the statistical analysis. Means and standard deviation or median with interquartile range will be reported for continuous data based on the normality assumption. The frequency with percentages will be registered for the categorical variables to describe the risk identifiers using the NCD tool kit, a crucial tool in our study. Internal consistency as validity evidence of the assessment can be determined using Cronbach’s alpha and the content validation index.

Qualitative analysis: Two researchers will perform the content analysis of the FGD. These FGDs will follow the COREQ checklist mentioned in the method section. 28 The audio-recorded interview will be transcribed. The transcribed verbatim will be verified against the recording by the researchers. Both researchers agree with Morse and Niehaus’s steps 29 of content analysis to analyse the narrative data. Initially, both researchers will read the transcripts several times to familiarise themselves with the data. Next, they will organise the transcript’s content under their respective questions. Then, they will focus on each question separately to generate initial codes (reduced sentences into meaningful phrases and words). They will cluster all the primary-level codes following axial coding to create categories. The entire research team will review the process of coding and content analysis. The research team will arbitrate all discrepancies. During content analysis, both researchers will record relevant participants’ excerpts to ensure the trustworthiness of the data. Strict privacy and confidentiality will be maintained for data and recordings of the interviews. The anonymity of research participants will be held by using pseudonyms throughout transcription and analysis.

 Results

The study will consist of the following outcomes:

The qualitative study will generate thematic data and incorporate the users’ suggestions. The first version of the application will be a discussion version only. They will comment on the idea of the App, the use of tech, the content, the language used, and any other points that have not been considered, given the novelty of the innovation.

A developed app with pre-validated tools for NCDs and a dashboard to monitor active data collection and processes as the data is collected live.

Process outcomes that will be measured by checking the frequency of use of the NCD pre-validated tool, the number of times the questionnaires were visited, the most visited and the least visited section of the mHealth application, and any technical issues or glitches that were faced during the use of the application.

Qualitative Exit feedback will be taken from members of the community to gauge their understanding of their risk of NCDs after the use of the pre-validated tools and then with any doctors available at the Basic Health Unit, the LHW coordinator, Lady Health Visitors, and the LHWs after the intervention. Community members will also capture end-user experiences for details on the features and functions of the mHealth application.

Discussion

NCDs are a major global health challenge, straining public health systems worldwide. Diseases like stroke, ischemic heart disease, cancer, diabetes, mental health, and respiratory disorders are influenced by a multitude of factors. NCDs are responsible for the deaths of more than 41 million people each year. Moreover, 17 million people die of NCDs before reaching the age of 70, 86% of which deaths have been reported from low-middle income countries. 30

This study will primarily focuses on assessing the acceptability and scalability of an IT-based mobile health application for risk assessment of non-communicable diseases using LHWs. Many mobile applications have been utilised in healthcare systems for better health outcomes and patient management. Such applications include One Drop Health 31 for diabetes management. While such applications are gaining traction globally, Pakistan faces significant challenges. As a resource-constrained, low-middle-income country, it struggles with limited funding, inadequate technical expertise, socio-cultural barriers, and other obstacles to development and implementation.

Currently, various initiatives have been introduced by the government to mitigate the prevalence of NCDs. Firstly, the National Action Plan for Prevention and Control of Non-communicable Diseases and Health Promotion in Pakistan 32 (NAP-NAD) was introduced in 2004 and revised in 2014. The framework behind NAP-NAD identified risk factors associated with NCDs and promoted healthy lifestyles. Secondly, the National Tobacco Control Cell (NTCC) 33 was established in 2007 to ban smoking in public places, raise taxes, and regulate the advertisement of tobacco products. Despite aiming to reduce the burden of NCDs, these initiatives had a limited impact in Pakistan due to various technical and systemic challenges.

As a result, LHWs in Pakistan can be empowered and equipped with mobile health applications to overcome such challenges. Community health workers empowerment will benefit Pakistan’s urban areas and, more importantly, target the rural areas where most of the population resides. Recently, one government-led initiative was the introduction of the Sehat Card 34 to provide health insurance to low-income and vulnerable populations. The introduction of LHWs and Sehat Card initiatives highlights the significant impact workforce innovations can have on improving healthcare delivery.

Keeping this in mind, integrating a mHealth application to develop a digitally-driven healthcare system through LHWs can help identify and mitigate the disease burden of NCDs in Pakistan. Moreover, such mobile applications can help identify the gaps in the country’s unique challenges, including socio-cultural factors, infrastructure already in place, practices of healthcare professionals, and lack of knowledge and awareness regarding NCDs. The development of mobile applications based on the Pakistani context can lead to their acceptability and scalability, potentially reducing the burden of NCDs in the future.

 Ethics Statement

This is a low-risk study of an IT-based application for risk assessment of non-communicable diseases by lady health workers.

Ethical approval was obtained from the Ethical Review Committee, The Aga Khan University, Karachi, Pakistan. Approval number: ERC# 2023-8215-24899, and the National Bioethics Committee, Islamabad, Pakistan, NBC# 4-87/NBC-976/23/104.

This study will involve human participants, the researchers will ensure that they will follow all the ethical principles laid down by the World Medical Association as the Declaration of Helsinki (World Medical Association, 2013). Hence the researcher will ensure that there is no breach of rights of participants during the conduct of the study.

All participants will provide written consent before participating in the study. All data collected will be handled confidentially and anonymized to safeguard participants’ identities. Data will be recorded on user-specific and password-protected computers, synced daily, and stored on a central server. Only the PI and Co-PIs will have access to the data. Data entry errors will be checked routinely. We plan to disseminate the results to participants and researchers involved in this pilot study. The findings will also inform future large-scale studies for NCD management in resource-limited settings. We plan to publish our findings in peer-reviewed publications, journals and academic conferences.

 Consent for publication

Consent will be given willfully.

 Availability of data and materials

No data are associated with this article.

 Acknowledgements

We want to acknowledge the Lady Healthcare Workers, Lady Health Supervisors, and District Health Office for taking time from their busy schedules and contributing to facilitating the ongoing study. We want to thank the Aga Khan administration, transport, nutrition and food Services for their support.

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