Evaluating the Acceptability, Feasibility and Usability of Various Conversational Data Collection Software
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Digital Biopsychosocial Conversational Data Collection Software, Standard Digital Questionnaire Data Collection.
- Кому может быть актуально
- Состояния в реестре: Chronic Pain, Mental Health Disorders, Behavioral Health Challenges, Ecological Momentary Assessment Best Practices. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Evaluating the Acceptability, Feasibility and Usability of Various Digital Biopsychosocial Conversational Data Collection Software in a Patient Population With Chronic Pain
Обзор
This research study is being conducted to evaluate digital software tools that collect health information through conversations. The study will test how acceptable, feasible, and usable these conversational software programs are for patients with chronic pain. Purpose of the Study: The goal is to understand whether digital conversational tools can effectively gather biopsychosocial information (biological, psychological, and social factors related to health) from patients experiencing chronic pain. Biopsychosocial information includes details about your physical symptoms, emotional well-being, social circumstances, and how these factors interact to affect your health. These digital tools are designed to have conversation-like interactions with patients to collect this comprehensive health data in a more natural and engaging way. What Participation Involves: If you join this study, you will interact with digital conversational software that will ask you questions about your health, pain experience, and related factors. The software is designed to communicate with you in a conversational manner, similar to talking with a healthcare provider, to gather information about your condition. You will be asked about various aspects of your chronic pain experience, including how it affects your daily life, your emotional state, and your social interactions. Who Can Participate: This study is looking for participants who have chronic pain conditions. Medical providers who treat patients with chronic pain are encouraged to refer eligible patients to this study. Healthcare providers interested in referring patients or learning more about the study can contact the study sponsor, AugMend Health Inc. Why This Research Matters: Chronic pain affects millions of people and understanding the full scope of how it impacts patients requires collecting detailed information about physical, psychological, and social factors. Traditional methods of collecting this information can be time-consuming and may not capture the complete picture. Digital conversational tools offer a potential new approach to gathering comprehensive health information in a more efficient and patient-friendly manner. This research will evaluate whether patients find these tools acceptable to use, whether they work practically in real-world clinical settings, and whether they are user-friendly and accessible for people with chronic pain. Study Location: The study is being conducted at AugMend Health in Cambridge, Massachusetts. Study Sponsor: This study is sponsored by AugMend Health Inc. Healthcare providers or potential participants who would like more information about the study or wish to make a referral can contact AugMend Health Inc. Participation in this study is voluntary, and you can choose to stop participating at any time without affecting your regular medical care.
Подробное описание
Study Design and Methodology:
This is a research study designed to systematically evaluate various digital biopsychosocial data collection software platforms in a population of patients with chronic pain. The study will assess three key dimensions: acceptability (whether patients find the tools appropriate and are willing to use them), feasibility (whether the tools can be practically implemented in real-world clinical settings), and usability (how easy and intuitive the tools are for patients to interact with).
The study employs a comparative design to rigorously evaluate different approaches to collecting biopsychosocial information from patients with chronic pain. Participants will be assigned to use different data collection methods, allowing researchers to compare the effectiveness, user experience, and practical implementation considerations across multiple approaches. This comparative framework is essential for determining which methods work best for patients and healthcare systems.
Background and Rationale:
Chronic pain is a complex, multifaceted condition that requires comprehensive assessment of biological, psychological, and social factors to effectively understand and manage. The biopsychosocial model of pain recognizes that pain experiences cannot be fully understood by examining biological factors alone. Psychological factors such as mood, stress, coping strategies, and pain-related beliefs significantly influence pain perception and disability. Social factors including work status, family support, social isolation, and economic circumstances also play crucial roles in the chronic pain experience.
Traditional data collection methods in clinical settings often rely on paper-based questionnaires, structured interviews, or electronic forms that may not capture the nuanced, contextual information needed for holistic pain management. These conventional approaches have several limitations: they may be time-consuming for both patients and providers, can suffer from incomplete responses, may not adapt to individual patient circumstances, and often fail to capture the interconnected nature of biopsychosocial factors. Additionally, patients may experience questionnaire fatigue when faced with lengthy assessment batteries, potentially compromising data quality.
The emergence of digital health technologies has created new opportunities for patient-centered data collection. Digital platforms can potentially offer more engaging, adaptive, and comprehensive methods for gathering biopsychosocial information. However, before such tools can be widely adopted in clinical practice, it is essential to rigorously evaluate whether they meet the needs of both patients and healthcare providers. Key questions include: Do patients find these tools acceptable? Can they be practically implemented in various settings? Are they intuitive and easy for patients to use? How do they compare to existing methods?
Study Procedures and Participant Experience:
Participants enrolled in this study will engage with digital software platforms designed to collect biopsychosocial data relevant to their chronic pain condition. The software will gather information about various aspects of their pain experience, physical functioning, emotional well-being, social circumstances, and other relevant health factors.
Depending on their assigned study group, participants may interact with the data collection tools in different settings and formats. Some participants will complete study procedures at home using their own devices or equipment provided by the study team. Other participants will visit the MIT.nano Immersion Lab, a specialized research facility designed for studying human-technology interactions in controlled environments. The MIT.nano Immersion Lab provides advanced technical infrastructure and a setting specifically designed to evaluate innovative data collection approaches.
The flexibility in study locations allows researchers to evaluate how different environmental contexts may affect the data collection experience. Home-based participation offers convenience and the comfort of a familiar environment, while the laboratory setting provides controlled conditions and access to specialized equipment. Understanding how location affects acceptability, feasibility, and usability is an important aspect of determining how these tools might be deployed in real-world clinical practice.
Throughout their participation, patients will be asked to provide comprehensive feedback on their experience with the data collection methods. This feedback will help researchers understand the acceptability of the tools from the patient perspective, including factors such as comfort level with the technology, perceived relevance of the information being collected, ease of use, time required, and overall satisfaction with the experience. Participants may be asked to complete questionnaires, provide verbal feedback, or participate in debriefing sessions to share their perspectives.
Comprehensive Evaluation Framework:
The study will employ multiple methods and metrics to thoroughly evaluate the digital data collection software:
Acceptability Assessment: Researchers will evaluate whether patients find the software acceptable for collecting sensitive health information. Acceptability encompasses multiple dimensions including appropriateness (whether patients feel the method is suitable for collecting health data), comfort (whether patients feel at ease during the data collection process), willingness (whether patients are open to using this method in the future), and trust (whether patients feel confident that their information is being handled appropriately). The study will systematically document patient attitudes, preferences, concerns, and suggestions for improvement.
Acceptability may vary across different patient subgroups, and the study will examine whether factors such as age, prior technology experience, pain severity, or other characteristics influence how patients respond to the data collection methods. Understanding these variations is crucial for ensuring that new tools are accessible and acceptable to diverse patient populations.
Feasibility Assessment: The study will examine practical considerations related to implementing these tools in clinical settings and real-world environments. Feasibility assessment includes evaluating technical requirements (such as hardware, software, and internet connectivity needs), integration with existing healthcare workflows and electronic health record systems, time required for patient interactions, staff training needs, technical reliability and system stability, cost considerations, and any barriers to implementation that emerge during the study.
Feasibility is assessed from multiple perspectives including the patient viewpoint (Can patients realistically use these tools given their circumstances?), the provider perspective (Can healthcare teams incorporate these tools into their practice?), and the systems level (Can healthcare organizations successfully deploy and maintain these technologies?). The study will document technical issues, logistical challenges, and resource requirements to provide a realistic assessment of implementation feasibility.
Usability Assessment: Researchers will assess how easy the software is for patients to use and how well the design meets user needs. Usability evaluation draws on established frameworks from human-computer interaction and user experience research. Key usability dimensions include learnability (how quickly can new users understand how to use the system?), efficiency (how rapidly can users complete tasks?), memorability (can users easily use the system again after a period of not using it?), error prevention and recovery (does the system help prevent errors and allow users to recover when errors occur?), and satisfaction (how pleasant is the system to use?).
The study will identify specific usability issues that patients encounter, such as confusing instructions, unclear navigation, technical difficulties, or design elements that create frustration. This detailed feedback will inform iterative improvements to the software design. Special attention will be paid to ensuring that the tools are usable for patients with varying levels of technical proficiency and those who may have physical or cognitive limitations related to their chronic pain condition.
Population Focus and Clinical Context:
The study specifically focuses on patients with chronic pain because this population faces unique challenges in healthcare data collection and represents a significant public health concern. Chronic pain affects an estimated 20-50% of the adult population in developed countries and is one of the most common reasons for seeking medical care. The economic burden of chronic pain is substantial, including direct medical costs, lost productivity, and reduced quality of life.
Chronic pain patients often have complex medical histories involving multiple healthcare providers, various treatment approaches, and numerous medications. Many have comorbid conditions such as depression, anxiety, sleep disorders, or other chronic illnesses that interact with their pain condition. The multidimensional nature of chronic pain makes it an ideal condition for evaluating comprehensive biopsychosocial data collection tools.
Furthermore, chronic pain patients frequently interact with healthcare systems over extended periods, often for years or decades. This longitudinal nature of care makes efficient, effective, and patient-friendly data collection particularly valuable. If patients find data collection burdensome or irrelevant, engagement with care may suffer. Conversely, if data collection is perceived as valuable and manageable, it may enhance the therapeutic relationship and improve outcomes.
The chronic pain population also exhibits significant heterogeneity in terms of pain conditions (back pain, neuropathic pain, fibromyalgia, arthritis, etc.), age ranges, functional status, and psychosocial circumstances. This diversity provides an excellent opportunity to evaluate whether digital data collection tools work across different patient subgroups or whether certain approaches are better suited to specific populations.
Clinical Significance and Healthcare Impact:
The findings from this study have the potential to significantly impact how patient information is gathered in clinical settings. Current healthcare practice faces multiple challenges related to data collection: providers have limited time with patients, electronic health records are often cumbersome to use, patient-reported information may be incomplete, and the biopsychosocial factors crucial for understanding chronic conditions are frequently under-documented.
If the digital software platforms evaluated in this study prove to be acceptable, feasible, and usable for chronic pain patients, they could represent a significant advancement in healthcare data collection. Potential benefits include: reducing administrative burden on healthcare providers by automating aspects of data collection; improving the completeness and quality of patient data by using systematic collection methods; enhancing patient engagement in their own care by providing more interactive and meaningful data collection experiences; enabling more frequent monitoring of patient status between clinical visits; providing richer, more nuanced insights into the biopsychosocial factors affecting health outcomes; and creating structured data that can be more easily analyzed to identify patterns and inform treatment decisions.
Beyond chronic pain, the lessons learned from this study may have broader applicability to other chronic conditions that require comprehensive biopsychosocial assessment, such as mental health disorders, cardiovascular disease, diabetes, and cancer. The methodological approaches used in this study to ev
Вмешательства
- Другое Digital Biopsychosocial Conversational Data Collection Software
This intervention involves participants interacting with digital conversational software that uses artificial intelligence and natural language processing to collect biopsychosocial health information. The software engages participants in dialogue-based interactions, asking questions about their chronic pain experience, physical functioning, emotional well-being, and social circumstances. The conversational interface adapts to participant responses, can ask follow-up questions for clarification - Другое Standard Digital Questionnaire Data Collection
This intervention involves participants completing standard digital questionnaires or surveys to provide biopsychosocial health information. Participants respond to predetermined, fixed-format questions about their chronic pain experience, physical functioning, emotional well-being, and social circumstances. The data collection uses conventional electronic forms or surveys with static question sets that do not adapt based on participant responses. Questions are presented in a standard sequence
Первичные конечные точки
- Acceptability [Срок оценки: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)]
- Usability [Срок оценки: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)]
- Technical Feasibility [Срок оценки: Assessed throughout study participation (typically within 1-2 weeks of enrollment)]
- Implementation Feasibility [Срок оценки: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)]
- Data Collection Feasibility [Срок оценки: Assessed at completion of all data collection procedures (typically within 1-2 weeks of enrollment)]
Вторичные конечные точки (5)
- Participant Experience & Satisfaction [Срок оценки: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)]
- Patient Engagement - Session Duration [Срок оценки: Measured during each data collection session (typically within 1-2 weeks of enrollment)]
- Patient Engagement - Response Elaboration [Срок оценки: Measured during each data collection session (typically within 1-2 weeks of enrollment)]
- Perceived Therapeutic Alliance [Срок оценки: Assessed immediately after completion of conversational data collection (typically within 1-2 weeks of enrollment)]
- Immersion and Comfort [Срок оценки: Assessed immediately after completion of immersive data collection (typically within 1-2 weeks of enrollment)]
Критерии участия
Критерии включения
- Adults aged 18 years or older
- Diagnosis of chronic pain (pain lasting 3 months or longer)
- Able to read and understand English
- Able to provide informed consent
- Willing and able to complete study procedures either at home or at the MIT.nano Immersion Lab
- Access to necessary technology for home-based participation (if assigned to home-based group), or ability to travel to the MIT.nano Immersion Lab (if assigned to laboratory-based group)
- Cognitively able to interact with digital data collection software and provide feedback
Критерии исключения
- Under 18 years of age
- Unable to provide informed consent
- Non-English speaking
- Acute pain only (pain lasting less than 3 months)
- Cognitive impairment that would prevent meaningful interaction with data collection software or ability to provide valid feedback
- Unable or unwilling to complete study procedures in assigned setting (home or laboratory)
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with the participant's ability to complete study procedures
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- AugMend Health at MIT.nano Immersion Lab — Cambridge
Идентификаторы
NCT: NCT07336537 · 0001