NCT07336537 · AugMend Health Inc.
Evaluating the Acceptability, Feasibility and Usability of Various Conversational Data Collection Software
(CADS)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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, and creates an interactive experience that mimics clinical interviews. Some implementations may utilize virtual reality (VR) environments to create immersive data collection experiences at the MIT.nano Immersion Lab. Participants interact with the software either at home using provided devices or at the MIT.nano Immersion Lab. The AI-driven platform standardizes data collection while maintaining conversational flexibility, collecting comprehensive biopsychosocial data through natural language
OTHER
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 without conversational elements or follow-up prompts. This represents traditional electronic data collection methods commonly used in clinical and research settings. Participants complete the questionnaires either at home using their own devices or provided equipment, or at designated study locations. This method provides a comparison baseline against which to evaluate newer digital data collection approaches, representing current standard practice for gathering patient-reported health informat
Primary outcome measures
Acceptability
Time frame: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)
Acceptability will be measured using the Acceptability, Feasibility and Usability Survey (AFUS) - Acceptability Subscale, a researcher-developed instrument. This subscale includes items from Part 1 (Core Assessment Experience), Part 2 (culture), Part 3 (Future Use \& Preference), Part 4 (Privacy \& Trust), and Part 5 (Medical Disclosure Comfort). Items are rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). Subscale scores will be calculated as the mean of all acceptability items. Higher scores indicate greater acceptability. Subscale breakdown will be accessible in supplemental figures of publications.
Usability
Time frame: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)
Usability will be measured using the Acceptability, Feasibility and Usability Survey (AFUS) - Usability Subscale (Part 6), a researcher-developed instrument adapted from established usability frameworks. The subscale consists of 10 items rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). Negatively-worded items are reverse-scored. The total score is calculated as the mean of all items. Higher scores indicate better usability.
Technical Feasibility
Time frame: Assessed throughout study participation (typically within 1-2 weeks of enrollment)
Technical feasibility will be measured by the proportion of data collection sessions completed without significant technical failures. A significant technical failure is defined as any system error, software malfunction, connectivity interruption, hardware issue, or other technical problem that results in early termination of the session. Technical success rate will be calculated as the number of sessions without significant technical failures divided by total sessions attempted, expressed as a percentage. Higher percentages indicate greater technical feasibility.
Implementation Feasibility
Time frame: Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)
Implementation feasibility will be measured using the Acceptability, Feasibility and Usability Survey (AFUS) - Future Use \& Preference Subscale (Part 3). Items assess participant willingness to use the data collection method again, likelihood of recommending it to others, and trust in the method for ongoing health evaluation. Items are rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). The subscale score is calculated as the mean of all items. Higher scores indicate greater implementation feasibility.
Data Collection Feasibility
Time frame: Assessed at completion of all data collection procedures (typically within 1-2 weeks of enrollment)
Feasibility of comprehensive data collection will be measured by the proportion of biopsychosocial domains for which data was successfully collected across all sessions. Domain coverage will be calculated as the number of domains with complete data divided by total possible domains, expressed as a percentage. Domains include biological (pain characteristics, sleep, physical function, nutrition), psychological (mood, cognition, coping, trauma, pain catastrophizing), and social (relationships, support, work, identity). Higher percentages indicate more comprehensive data collection.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Cambridge, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 13, 2026 · Source of record for eligibility and locations