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NCT Number: NCT06845007

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CUF

Lisbon, Lisbon District, 1000, Portugal

Location status: Recruiting

Location contact

Ana

CONTACT

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Semi-structured interview

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    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:

    • Do you consider PROMBot easy to use?
    • Do you consider PROMBot useful? Please answer yes or no.
    • Which types of messages from PROMBot were the most useful for you?
    • What improvements would you suggest for PROMBot?
    • Was interacting with PROMBot enjoyable?
    • Would you like to continue using PROMBot to record your blood pressure values? Why? Please briefly justify your reasons for wanting to continue or not.
    • Would you like to continue using PROMBot to receive medication reminders? Why? Please briefly justify your reasons for wanting to continue or not.
    • Would you like to continue using PROMBot to receive tips on healthy habits? Why? Please briefly justify your reasons for wanting to continue or not.

Secondary outcomes

  1. Engagement

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    The level of patient engagement will be measured by calculating a proxy based on the number of messages sent to the chatbot.

  2. Treatment Adherence

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    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.

  3. Health Literacy

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    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.

  4. Intra-Individual Effects

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    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.

  5. Intra-Individual Effects

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    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.

  6. Intra-Individual Effects

    Time frame: After interacting with the chatboot, which took place over 12 weeks.

    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.

Other outcomes

  1. Gender

    Time frame: Before the interaction with the chatboot begins

    Personal Identification : Gender, Male / Female

  2. Age

    Time frame: Before the interaction with the chatboot begins

    Personal Identification : Age (years).

  3. Education Level

    Time frame: Before the interaction with the chatboot begins

    Personal Identification : Education Level.

  4. Primary Diagnosis

    Time frame: Before the interaction with the chatboot begins

    Current Condition: Primary Diagnosis: Essential high blood pressure; Secondary high blood pressure

  5. Blood Pressure

    Time frame: Before the interaction with the chatboot begins

    Current Condition: Blood Pressure (Systolic and diastolic) values recorded throughout the program.

  6. Behavioral assessment - Medication

    Time frame: Before the interaction with the chatboot begins

    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

  7. Physical exercise engagement

    Time frame: Before the interaction with the chatboot begins

    Days on which the patient requested information about exercise (number of days)

  8. Healthy recipes engagement

    Time frame: Before the interaction with the chatboot begins

    Days on which the patient requested information about exercise (number of days)

Study contacts

Contact information is provided by the study sponsor or research team.

Soraia Ferreira, PhD

CONTACT

[email protected]

969307101

Sponsors and collaborators

Lead sponsor

Ana Rita Londral

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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