Study design and participants

The research conducted a comparative analysis to assess the clinical outcomes of individuals diagnosed with COPD before and after onboarding patients on the MyTatva app embedded with the algorithm. The study involved a sample of 10 COPD patients, evaluating key parameters such as Forced Expiratory Volume in 1 s (FEV1), Forced Vital Capacity (FVC), Weight, Body Mass Index (BMI), Fat free mass index (FFMI) and Distance Covered during the 6-Minute Walk Test (6MWT). Data collection occurred at two distinct time points: pre and post onboarding of the patients in the MyTatva app. Statistical analysis was performed to determine the significance of the differences in these parameters. The primary aim of this comparative analysis was to assess the algorithm’s efficacy in improving COPD management and enhancing the clinical outcomes of the participants within the MyTatva app environment.

The eligibility criteria for the study included adults aged between 40 and 75 years with diagnosed cases of COPD confirmed by spirometry results (FEV1/FVC ratio < 0.7 post-bronchodilator). Participants were required to be capable of understanding and consistently using the MyTatva app and willing to adhere to the dietary, lifestyle, and monitoring interventions outlined in the study protocol. The study excluded individuals with unstable comorbidities, such as heart failure or acute infections, pregnant or lactating women, patients with cognitive impairments that could hinder adherence to the study requirements, and those already engaged in other conflicting clinical trials.

Research objective

The study aims to develop and implement an algorithm within the MyTatva app to enhance clinical outcomes for patients with COPD. The research objective focuses on evaluating the impact of the algorithm on COPD patients by assessing key parameters such as lung function, weight, body composition, and exercise capacity before and after the algorithm’s implementation in the MyTatva app. The algorithm, centered around nutrition and diet intervention, aims to improve various aspects of COPD management within the app. The key components of the algorithm include strategies for weight normalization, improvement in Body Mass Index (BMI) and wight management, monitoring the 6-Minute Walk Test (6MWT) through smart wearables, facilitating diet adherence via an in-app food diary, and monitoring Forced Expiratory Volume in 1 s (FEV1) rates using a Bluetooth-enabled spirometer. While these components may seem overlapping in their focus on health and COPD management, they collectively contribute to a comprehensive approach to addressing COPD symptoms and improving patients’ quality of life. The 6-Minute Walk Test (6MWT) was used to assess physical performance as it is a widely validated, simple, and non-invasive measure of functional exercise capacity, reflecting the overall endurance and physical capabilities of COPD patients in real-world settings. Fat-Free Mass Index (FFMI) was used to assess body composition as it provides a reliable indication of muscle mass, which is crucial for evaluating nutritional status and sarcopenia, both of which significantly impact respiratory function and overall health in COPD patients.

Search strategy

A rigorous literature search was conducted, focusing on articles published in scholarly databases such as PubMed, Google Scholar, ScienceDirect, and Web of Science. The search string employed was as follows: “(Digital therapeutics OR DTx, FDA OR SaMD OR MDD OR MDR, Digital health OR Healthcare, Smartphone OR Application, diet, dietary factor, food, nutrition, nutrient, antioxidant, calorie intake, dietary pattern, food pattern, eating habit, lung function, CAT score, MUST score, weight management, 6MWT, FEV1, chronic obstructive pulmonary disease, and COPD)”. It is important to note that the search was limited to articles that could be identified using this specific search string. Articles from other sources, such as research protocols, conference abstracts, theses, preprints, news articles, and workshop proceedings, were excluded. This was done to ensure that the selected articles were published in reputable sources and met high standards of scientific research.

Algorithm development

The process of algorithm development involved thorough research in nutrition-based outcome studies conducted in COPD patients. These studies yielded invaluable insights and served as a fundamental basis for establishing pre-existing timelines that were further substantiated by literature evidence. This approach ensured that the selected outcomes were solely related to the impact of nutrition on COPD management. To establish the timelines for assessing these outcomes, the expected timeframes within which nutrition-based interventions typically show measurable effects were considered. This involved examining the duration of dietary interventions in the literature and determining when significant changes in the selected outcomes were observed. These timelines were then incorporated into the algorithm to guide healthcare professionals in monitoring and evaluating the effectiveness of nutrition interventions for COPD patients.

Patient onboarding on the Mytatva app

Once a COPD patient is onboarded on the My Tatva app, they undergo a comprehensive health assessment to understand various aspects of their well-being. This includes measuring BMI, muscle mass, and fat free mass index, conducting spirometry to measure FEV1 score, observing CAT and MUST scores, recording comorbidities, and performing a nutritional assessment covering dietary preferences, food allergies, and lifestyle habits.

Based on this assessment, a personalized dietary plan was developed by a clinical nutritionist. The plan includes specific instructions tailored to the patient’s requirements, such as macronutrient distribution, portion sizes, and food choices. It also incorporates practical elements such as recipes and recommendations for nutrient-rich snacks.

Patients have the opportunity to engage with the nutritionist through voice or video communication, allowing for further discussion and setting health objectives. Bimonthly chat sessions are conducted to track progress, address concerns, and answer any questions.

Throughout the process, patients are encouraged to log their food intake, water consumption, sleep patterns, physical activity, respiration metrics, and ambulatory strides using the My Tatva app. The app provides timely reminders for appointments and meal schedules to improve adherence.

Regular assessments are conducted to evaluate progress, including changes in weight, improvements in symptoms, adherence to the dietary plan, Fat-Free Mass Index, 6-Minute Walk Test, and Forced Expiratory Volume in 1 s rate. This ongoing support and monitoring aim to effectively manage COPD and enhance the patient’s overall health and well-being.

The My Tatva app provides a comprehensive approach to personalized nutrition therapy, ensuring that COPD patients receive tailored care and support throughout their journey (Fig. 2).

Fig. 2

Patient journey’s on the MyTatva app

Patients’ safety

The MyTatva app incorporates an incident reporting feature that empowers patients to promptly report any adverse events they may experience during the course of the intervention.

Patient feedback surveys

To evaluate customer satisfaction at various stages of the MyTatva care plan, a structured CSAT survey was conducted after key interactions. The survey consisted of targeted questions to assess satisfaction levels and user experiences through a CSAT survey form (refer to annexure 1).

Implementation of algorithm in Mytatva app

The management of COPD has traditionally focused on pharmacological treatment. However, there is growing recognition of the importance of incorporating diet and nutrition-based interventions to improve patient outcomes. As highlighted in the introduction, research has shown that nutritional counseling, dietary supplementation, and antioxidant-rich diets can address malnutrition, improve symptom management, and enhance Body Mass Index (BMI) among COPD patients. These interventions also have the potential to positively influence the quality of life of COPD patients and reduce healthcare costs associated with the disease.

To optimize patient outcomes, a comprehensive nutritional intervention algorithm has been developed and integrated into the MyTatva application, as described in the methodology section. This algorithm facilitates clinical nutritionists in creating a personalized patient profile by conducting a thorough assessment of clinical, lifestyle, and nutritional factors. Following the patient registration on the MyTatva platform, a detailed assessment is performed of their clinical history, lifestyle factors, and nutritional status.

The algorithm employs a comprehensive evaluation of five essential factors to create patient profiles. This includes analyzing the patient’s BMI and weight management using a BCA machine, as well as capturing Forced Expiratory Volume in 1 s (FEV1) readings with a Bluetooth-enabled spirometer to assess COPD severity. By considering these factors, clinical nutritionists can develop personalized nutritional recommendations that improve patient outcomes and reduce healthcare costs.

The MyTatva application utilizes electronic patient-reported outcomes (ePROs) to calculate COPD Assessment Test (CAT) and Malnutrition Universal Screening Tool (MUST) scores. These scores help identify potential malnutrition risks and the severity of COPD, as outlined in the introduction. The 24-h dietary recall captures information on the patient’s diet, food frequency, regional cuisine, and food allergies. The patient’s BMI is categorized to determine appropriate caloric intake and nutritional requirements. The CAT score categorizes the impact of COPD on the patient’s life, while the MUST score stratifies the risk of malnutrition. Comorbidities such as hypertension, diabetes, dyslipidemia, and cardiovascular disease are also considered for specific nutritional modifications.

The algorithm also takes into account the patient’s lifestyle data, including smoking, alcohol, sleep, and stress habits. This information is gathered through a lifestyle challenge questionnaire on the MyTatva app. It helps create a comprehensive patient profile for initiating nutrition therapy, as described in the methodology section.

A customized diet plan, referred to as Diet Plan 1, is developed to meet the patient’s specific nutritional requirements while aligning with their preferences. The algorithm respects cultural and regional food habits, incorporating specific area-dominated diets to promote patient satisfaction and adherence.

Monitoring patient progress is an integral part of the algorithmic approach. Regular assessments, including lifestyle, nutritional, and clinical evaluations, are conducted from day 1 to track patient progress, as mentioned in the methodology. These assessments provide valuable feedback on the effectiveness of the diet plan and allow for necessary adjustments.

The initial diet plan, Diet Plan 1, spans a 15-day program. If the patient adheres to the plan with at least 80% compliance, improvements in symptoms, weight, and weight management are assessed. If positive improvements are observed, the patient progresses to Diet Plan 2, which lasts for one month. Diet Plan 2 builds upon the initial plan by incorporating more specific goals and adjustments based on the patient’s progress and feedback. Throughout Diet Plan 2, the patient continues to follow the personalized diet plan while receiving ongoing support and guidance from the clinical nutritionist. Regular assessments are conducted to monitor adherence to the plan and track progress in terms of symptoms, weight, and weight management.

The MyTatva application plays a crucial role in facilitating communication and monitoring between the patient and the clinical nutritionist, as described in the methodology. Patients can record their food diary on the app, providing valuable information for assessing adherence to the diet plan. The app also allows patients to track their progress, including symptoms, weight, and weight management, and communicate any concerns or feedback to the clinical nutritionist.

The algorithmic approach employed in this study ensures a systematic and structured process for managing COPD through diet- and nutrition-based interventions. By considering various factors, such as clinical data, lifestyle habits, dietary preferences, and regional considerations, the algorithm helps create personalized diet plans tailored to the individual needs of each patient, as outlined in the methodology (Fig. 3).

Fig. 3

COPD patient approach algorithm on the MyTatva App

Statistical analysis

Statistical analysis was performed using SPSS version 25. Continuous variables, such as FEV1, BMI, and 6MWT distance, were analyzed using the Wilcoxon signed-rank test to compare pre- and post-intervention values, as the sample size was small and data distribution non-normal. Results were summarized as medians with interquartile ranges, and a p-value < 0.05 was considered statistically significant. Descriptive statistics were used for baseline characteristics, and categorical data were presented as frequencies and percentages.