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Recruiting NCT06845007

PROMBot: a Web Platform for Collecting Outcomes for Hypertension Patients Via a Chatbot

Observational Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

PROMBot: a Web Platform for Collecting Patient-Reported Outcome Measures Via a Chatbot

Overview

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.

Detailed description

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:

1. To obtain a more continuous blood pressure history to personalize healthcare 2. To provide information to healthcare professionals about the knowledge acquired by the patient regarding the behavior to adopt 3. To evaluate improvements in participants' health-related knowledge and behaviors, such as salt consumption, physical exercise practices, medication adherence, and preparation of healthy meals 4. To study patient engagement levels with the chatbot and assess treatment adherence throughout the program 5. To evaluate the ease of use and perception of usefulness of the chatbot by participants.

Primary outcome measures

  • Semi-structured interview [Time frame: After interacting with the chatboot, which took place over 12 weeks.]
Secondary outcome measures (6)
  • Engagement [Time frame: After interacting with the chatboot, which took place over 12 weeks.]
  • Treatment Adherence [Time frame: After interacting with the chatboot, which took place over 12 weeks.]
  • Health Literacy [Time frame: After interacting with the chatboot, which took place over 12 weeks.]
  • Intra-Individual Effects [Time frame: After interacting with the chatboot, which took place over 12 weeks.]
  • Intra-Individual Effects [Time frame: After interacting with the chatboot, which took place over 12 weeks.]
  • Intra-Individual Effects [Time frame: After interacting with the chatboot, which took place over 12 weeks.]

Eligibility criteria

Inclusion criteria

  • Aged between 18 and 75 years old.
  • Diagnosed with hypertension, based on ICD-9 codes (401-401.9).
  • Independent in performing activities of daily living.
  • Ability to respond to SMS messages.

Exclusion criteria

  • Diagnosis of Parkinson's disease.
  • Refusal to sign the informed consent form.
  • Diagnosis of cancer.
  • Mobility limitations that prevent engaging in physical activity.
  • Lack of a smartphone with internet access.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Portugal · 1 center
  • CUF — Lisbon

Publications

  • 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. PMID 31314689
  • 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. PMID 33723721
  • 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. PMID 37353578
  • 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. PMID 21886870
  • 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. PMID 22283360
  • 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. PMID 33503681
  • 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. PMID 17329725
  • 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. PMID 27116181

Identifiers

NCT: NCT06845007 · VOH_PROMBOT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗