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临床试验/NCT06845007
NCT06845007已完成不适用

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

Ana Rita Londral1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Semi-structured interview

研究概览

简要总结

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.

详细描述

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 and technology utilization. Therefore, the use of participatory action research (PAR) methodologies, which actively involve clinical teams in the research process, is essential to ensure that the technological solutions developed and implemented align with users' needs and preferences, thereby maximizing their adoption.

The PROMBot was created using a PAR approach, incorporating feedback from various stakeholders, including 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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Semi-structured interview

时间窗: 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.

次要结局

  • Engagement(After interacting with the chatboot, which took place over 12 weeks.)
  • Health Literacy(After interacting with the chatboot, which took place over 12 weeks.)
  • Treatment Adherence(After interacting with the chatboot, which took place over 12 weeks.)
  • Intra-Individual Effects(After interacting with the chatboot, which took place over 12 weeks.)

研究者

发起方
Ana Rita Londral
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ana Rita Londral

Investigator

Value for Health CoLAB

研究点 (1)

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