Clinical trial NCT06845007: PROMBot: a Web Platform for Collecting Outcomes for Hypertension Patients Via a Chatbot
Official title: PROMBot: a Web Platform for Collecting Patient-Reported Outcome Measures Via a Chatbot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Keywords: Chatbot
Web plataform
PROMBot
Patient Monitoring
Lead sponsor: Value for Health CoLAB
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants must have hypertension, live in Portugal and be followed by a doctor at the CUF hospital.

Brief summary: 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.

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.

Primary outcomes:
measure: Semi-structured interview
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
Secondary outcomes:
measure: Engagement
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
measure: Treatment Adherence
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
measure: Health Literacy
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
measure: Intra-Individual Effects
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
measure: Intra-Individual Effects
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
measure: Intra-Individual Effects
timeFrame: After interacting with the chatboot, which took place over 12 weeks.
Other outcomes:
measure: Gender
timeFrame: Before the interaction with the chatboot begins
measure: Age
timeFrame: Before the interaction with the chatboot begins
measure: Education Level
timeFrame: Before the interaction with the chatboot begins
measure: Primary Diagnosis
timeFrame: Before the interaction with the chatboot begins
measure: Blood Pressure
timeFrame: Before the interaction with the chatboot begins
measure: Behavioral assessment - Medication
timeFrame: Before the interaction with the chatboot begins
measure: Physical exercise engagement
timeFrame: Before the interaction with the chatboot begins
measure: Healthy recipes engagement
timeFrame: Before the interaction with the chatboot begins
Locations:
city: Lisboa
country: Portugal
facility: CUF
Study officials:
References:
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