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

March 10, 2025 updated by: Ana Rita Londral

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Lisboa, Portugal, 1000
        • Recruiting
        • CUF
        • Contact:
          • Ana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Do you consider PROMBot easy to use?
  2. Do you consider PROMBot useful? Please answer yes or no.
  3. Which types of messages from PROMBot were the most useful for you?
  4. What improvements would you suggest for PROMBot?
  5. Was interacting with PROMBot enjoyable?
  6. 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.
  7. Would you like to continue using PROMBot to receive medication reminders? Why? Please briefly justify your reasons for wanting to continue or not.
  8. 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.
After interacting with the chatboot, which took place over 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.

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
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.
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.

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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Before the interaction with the chatboot begins
Personal Identification : Gender, Male / Female
Before the interaction with the chatboot begins
Age
Time Frame: Before the interaction with the chatboot begins
Personal Identification : Age (years).
Before the interaction with the chatboot begins
Education Level
Time Frame: Before the interaction with the chatboot begins
Personal Identification : Education Level.
Before the interaction with the chatboot begins
Primary Diagnosis
Time Frame: Before the interaction with the chatboot begins
Current Condition: Primary Diagnosis: Essential high blood pressure; Secondary high blood pressure
Before the interaction with the chatboot begins
Blood Pressure
Time Frame: Before the interaction with the chatboot begins
Current Condition: Blood Pressure (Systolic and diastolic) values recorded throughout the program.
Before the interaction with the chatboot begins
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
Before the interaction with the chatboot begins
Physical exercise engagement
Time Frame: Before the interaction with the chatboot begins
Days on which the patient requested information about exercise (number of days)
Before the interaction with the chatboot begins
Healthy recipes engagement
Time Frame: Before the interaction with the chatboot begins
Days on which the patient requested information about exercise (number of days)
Before the interaction with the chatboot begins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana Rita Londral

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOH_PROMBOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe