Evaluating the Acceptability, Feasibility and Usability of Various Digital Biopsychosocial Conversational Data Collection Software in a Patient Population With Chronic Pain
Trial ID: NCT07336537
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-10-03
Completion date: 2026-07-31
Sponsor: AugMend Health Inc.
Conditions: Chronic Pain; Mental Health Disorders; Behavioral Health Challenges; Ecological Momentary Assessment Best Practices
Interventions: Digital Biopsychosocial Conversational Data Collection Software; Standard Digital Questionnaire Data Collection
Locations: AugMend Health at MIT.nano Immersion Lab
Countries: United States
Enrollment: 100
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
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

Outcomes:
Acceptability; Usability; Technical Feasibility; Implementation Feasibility; Data Collection Feasibility