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The present study is observational and aims to evaluate the PROMBot service in managing patients' hypertension, simplify the follow-up process, and empower patients to actively participate in their own care.
In the last two decades, research and development (R&D) efforts in remote patient monitoring (RPM) technologies have primarily focused on the technical challenges of providing care in unconventional settings. Several pilot initiatives have emerged, ranging from chronic disease management to episodic care, such as post-surgical follow-ups, to leverage the advantages of RPM. These benefits include improving the continuity of outpatient care, enabling more informed health decision-making, anticipating complications, and reducing costs. For instance, in the context of post-surgical follow-up, RPM has demonstrated significant potential in reducing severe complications and increasing patient safety during the critical period following hospital discharge. By enabling healthcare professionals to continuously monitor clinical indicators and patient-reported outcome measures (PROMs), RPM plays a vital role in ensuring effective surveillance.
A systematic review highlights evidence that chatbots could be effective tools for increasing physical activity, fruit and vegetable consumption, and improving sleep duration and quality. In a recent study, users of a chatbot for hypertensive patients demonstrated greater knowledge and skills in blood pressure (BP) monitoring and slightly better accuracy in BP measurements.
However, there is still little research on implementation studies. After the COVID-19 pandemic, there was an increase in demand for RPM-based services due to postponed surgeries and the shift from in-person to remote care. As a result, ongoing pilot initiatives increased without sufficient planning. This lack of time and resources poses risks to both accessibility and care quality. Research is needed to explore the characteristics of different RPM systems that drive high-value RPM services.
Existing literature consistently emphasizes three key components for an effective RPM system: care team organization, technology utilization, and patient engagement activities. Therefore, using participatory action research (PAR) methodologies, where clinical teams and patients are actively involved in the research, becomes essential to ensure that the technological solutions developed and deployed align with the needs and preferences of end users, thereby maximizing solution adoption.
The PROMBot was created using a PAR approach, incorporating feedback from various stakeholders, including patients, healthcare professionals, software developers, and researchers. This collaborative effort allowed for the suggestion, testing, and evaluation of the platform's functionalities, ensuring both effectiveness and usability. By adopting a PAR approach, the development and implementation of the PROMBot platform addressed real-world challenges and requirements associated with implementing digital health services.
This study will last for 6 months and aims to evaluate the PROMBot service The implementation of the PROMBot platform in CUF's services serves two primary purposes: 1) to help CUF design and assess various remote follow-up interventions, and 2) to explore different use cases for the application of PROMBot By leveraging PROMBot, patients will have the ability to conveniently record their health parameters and symptoms daily Additionally, the platform will provide a user-friendly digital interface that supports care teams throughout the follow-up process.
This study is an observational study that will contribute to the exploration of different use cases for the implementation of innovative patient-centered systems, potentially positioning the patient monitoring service as a model to be followed by other clinical departments, both nationally and internationally By using technology and remote monitoring, this study aims to enhance patient care and set new standards for remote follow-up in the context of CUF, improving outcomes and promoting patient-centered healthcare practices.
The specific objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertension Group | This study includes only one group. This group will consist of patients with hypertension, and after a patient is identified, they will be followed up using the PROMBot platform for the subsequent 12 weeks. In the first week, the patient will be required to record their diastolic and systolic blood pressure values daily and answer a quiz on hypertension-related topics. In the second week, the participant will continue recording their blood pressure values, but only every other day. From the third to the tenth week, the participant may choose to receive tips on nutrition recipes and exercises they can perform to increase physical activity. In the 11th week, the participant will again measure their blood pressure, but the values will only be recorded on the 1st, 3rd, 5th, and 7th days. Finally, in the 12th week, the participant will resume recording daily blood pressure values in PROMBot. |
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| Measure | Description | Time Frame |
|---|---|---|
| Semi-structured interview | The semi-structured interviews will be conducted by the research team and aim to gather participants' reactions and experiences with the chatbot. The questions included in the interview are:
| After interacting with the chatboot, which took place over 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement | The level of patient engagement will be measured by calculating a proxy based on the number of messages sent to the chatbot. | After interacting with the chatboot, which took place over 12 weeks. |
| Treatment Adherence |
| Measure | Description | Time Frame |
|---|---|---|
| Gender | Personal Identification : Gender, Male / Female | Before the interaction with the chatboot begins |
| Age | Personal Identification : Age (years). |
Inclusion Criteria:
Exclusion Criteria:
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All study participants must have hypertension, live in Portugal and be followed by a doctor at the CUF hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soraia Ferreira, PhD | Contact | 969307101 | soraia.ferreira@vohcolab.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CUF | Recruiting | Lisbon | Lisbon District | 1000 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31314689 | Background | Farias FAC, Dagostini CM, Bicca YA, Falavigna VF, Falavigna A. Remote Patient Monitoring: A Systematic Review. Telemed J E Health. 2020 May;26(5):576-583. doi: 10.1089/tmj.2019.0066. Epub 2019 Jul 17. | |
| 33723721 | Background | Echeazarra L, Pereira J, Saracho R. TensioBot: a Chatbot Assistant for Self-Managed in-House Blood Pressure Checking. J Med Syst. 2021 Mar 15;45(4):54. doi: 10.1007/s10916-021-01730-x. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The level of treatment adherence will be measured by calculating a proxy based on the number of messages sent following blood pressure measurements by the patient.
| After interacting with the chatboot, which took place over 12 weeks. |
| Health Literacy | During the program, patients will be assessed on their knowledge of health literacy content related to hypertension in the following areas (self-reported): Health Literacy Knowledge Assessment on Hypertension Topics: Salt Consumption; Engagement in Physical Exercise. The questions will be multiple choice, with one correct answer for each question. | After interacting with the chatboot, which took place over 12 weeks. |
| Intra-Individual Effects | To evaluate the intra-individual effect of using PROMBot, participants will be invited to respond to four questions before and one week after the program to assess salt consumption habits, frequency of blood pressure measurement, and physical activity: Question 1: In the past week, how many days did you engage in physical exercise or any physical activity for 30 minutes or more? Possible response: 0 - None, 1 - 1 day, 2 - 2 days, 3 - 3 days, 4 - 4 days, 5 - 5 days, 6 - 6 days, 7 - 7 days. Question 2: In the past week, how many days did you record your blood pressure? Possible response: 0 - None, 1 - 1 day, 2 - 2 days, 3 - 3 days, 4 - 4 days, 5 - 5 days, 6 - 6 days, 7 - 7 days. The minimum value on this scale is 0 and the maximum value is 7. A higher score means a better result. | After interacting with the chatboot, which took place over 12 weeks. |
| Intra-Individual Effects | To evaluate the intra-individual effect of using PROMBot, participants will be invited to respond to four questions before and one week after the program to assess salt consumption habits, frequency of blood pressure measurement, and physical activity: Question 3: In the past week, how often did you add salt to your food? Possible response (Likert scale): 1 - Never or almost never, 2 - Sometimes, 3 - Most of the time, 4 - Always. The minimum value on this scale is 0 and the maximum value is 4. A higher score means a worse result. | After interacting with the chatboot, which took place over 12 weeks. |
| Intra-Individual Effects | To evaluate the intra-individual effect of using PROMBot, participants will be invited to respond to four questions before and one week after the program to assess salt consumption habits, frequency of blood pressure measurement, and physical activity: Question 4: In the past week, how often did you take your blood pressure medication as prescribed by your doctor? Possible response: 1 - Never, 2 - Rarely, 3 - Sometimes, 4 - Always. The minimum value on this scale is 0 and the maximum value is 4. A higher score means a better result. | After interacting with the chatboot, which took place over 12 weeks. |
| Before the interaction with the chatboot begins |
| Education Level | Personal Identification : Education Level. | Before the interaction with the chatboot begins |
| Primary Diagnosis | Current Condition: Primary Diagnosis: Essential high blood pressure; Secondary high blood pressure | Before the interaction with the chatboot begins |
| Blood Pressure | Current Condition: Blood Pressure (Systolic and diastolic) values recorded throughout the program. | Before the interaction with the chatboot begins |
| Behavioral assessment - Medication | Number of days the patient adhered to prescribed medication during the program (number of days). Na primeira semanas perguntamos 2 vezes ao dia (dia e noite). Na 2ª senana, 1º 4º 7º. nas semanas de intervalo pode receber ou não | Before the interaction with the chatboot begins |
| Physical exercise engagement | Days on which the patient requested information about exercise (number of days) | Before the interaction with the chatboot begins |
| Healthy recipes engagement | Days on which the patient requested information about exercise (number of days) | Before the interaction with the chatboot begins |
| 37353578 | Background | Singh B, Olds T, Brinsley J, Dumuid D, Virgara R, Matricciani L, Watson A, Szeto K, Eglitis E, Miatke A, Simpson CEM, Vandelanotte C, Maher C. Systematic review and meta-analysis of the effectiveness of chatbots on lifestyle behaviours. NPJ Digit Med. 2023 Jun 23;6(1):118. doi: 10.1038/s41746-023-00856-1. |
| 21886870 | Background | Park DK, Jung EY, Park RW, Lee YH, Hwang HJ, Son IA, Hu MH. Telecare system for cardiac surgery patients: implementation and effectiveness. Healthc Inform Res. 2011 Jun;17(2):93-100. doi: 10.4258/hir.2011.17.2.93. Epub 2011 Jun 30. |
| 22283360 | Background | Pekmezaris R, Mitzner I, Pecinka KR, Nouryan CN, Lesser ML, Siegel M, Swiderski JW, Moise G, Younker R Sr, Smolich K. The impact of remote patient monitoring (telehealth) upon Medicare beneficiaries with heart failure. Telemed J E Health. 2012 Mar;18(2):101-8. doi: 10.1089/tmj.2011.0095. Epub 2012 Jan 27. |
| 33503681 | Background | Baginski BN, Byrne KA, Vaz DG, Barber R, Blackhurst D, Tibbett TP, Guichard JL. Development and implementation of a remote patient monitoring program for heart failure: a single-centre experience. ESC Heart Fail. 2021 Apr;8(2):1349-1358. doi: 10.1002/ehf2.13214. Epub 2021 Jan 27. |
| 17329725 | Background | Pare G, Jaana M, Sicotte C. Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc. 2007 May-Jun;14(3):269-77. doi: 10.1197/jamia.M2270. Epub 2007 Feb 28. |
| 27116181 | Background | Vegesna A, Tran M, Angelaccio M, Arcona S. Remote Patient Monitoring via Non-Invasive Digital Technologies: A Systematic Review. Telemed J E Health. 2017 Jan;23(1):3-17. doi: 10.1089/tmj.2016.0051. Epub 2016 Apr 26. |