VA Augusta Health Care System
Augusta, Georgia, 30904, United States
Location status: Recruiting
NCT Number: NCT07776600
Chronic pain is a prevalent and debilitating condition among Veterans, often accompanied by depression, anxiety, sleep disturbances, and social isolation. Despite the availability of behavioral interventions many Veterans-particularly those with high in-person healthcare utilization-face barriers to accessing non-pharmacological pain management strategies. These barriers include limited clinician availability, geographic constraints, and digital exclusion among older or underserved populations.
This study aims to evaluate the feasibility, acceptability, and preliminary impact of My AI Companion, an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans. The intervention offers a low-barrier approach to promoting symptom tracking, patient activation, and engagement in coping strategies-without requiring Internet access or clinician time.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Augusta, Georgia, 30904, United States
Location status: Recruiting
This is a prospective cohort study with a retrospective matched comparison group. We will enroll 200 Veterans receiving care at VA Augusta Health Care System who meet criteria for high in-person healthcare utilization and have a diagnosis of chronic pain. One hundred participants will use the chatbot over a 12-month period and complete assessments at baseline, 3, 6, and 12 months. Primary outcomes include pain interference (PEG Scale), quality of life (VR-12), patient activation (PAM), self-efficacy, depression and anxiety symptoms (PROMIS), sleep disturbance (PROMIS), loneliness (UCLA), and substance use (AUDIT-C, DAST-10). We will also collect data on employment, caregiving roles, and opioid prescriptions. A retrospective comparison group will be identified from medical records to assess relative changes in healthcare utilization. The remaining 100 participants will act as the comparison group in this study is primarily identified through retrospective chart data, we will proactively invite a subset of these Veterans to complete the same self-reported measures as the intervention group (e.g., PEG, VR-12, PROMIS Depression/Anxiety, Sleep, Self-Efficacy, UCLA Loneliness, AUDIT-C, and DAST- 10). This approach will strengthen our ability to compare patient-reported outcomes across groups and provide valuable insights into the impact of the chatbot intervention. We will identify Veterans in the comparison group based on matched characteristics (e.g., high in-person healthcare utilization, chronic pain diagnosis, and demographic/clinical factors) and invite them to participate in survey assessments at baseline, 3, 6, and 12 months. Outreach will include an initial letter or email invitation explaining the study purpose, eligibility criteria, and procedures, followed by phone calls from the research team to answer questions, obtain consent, and support survey completion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following eligibility criteria to be enrolled in the study:
Exclusion criteria
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.
Time frame: baseline, 3, 6, and 12 months
Net Promoter Score
Time frame: baseline, 3, 6, and 12 months
Measure feasibility through enrollment, retention, and chatbot engagement data (e.g., number of interactions, session duration).
Time frame: baseline, 3, 6, and 12 months
PEG Scale (Pain intensity, Enjoyment of life, General activity)
Time frame: baseline, 3, 6, and 12 months
PROMIS Pain Interference Short Form
Time frame: baseline, 3, 6, and 12 months
UCLA Loneliness Scale (short form)
Time frame: baseline, 3, 6, and 12 months
VR-12 (Veteran-specific health-related quality of life)
Time frame: baseline, 3, 6, and 12 months
PROMIS Depression and Anxiety Short Forms
Time frame: baseline, 3, 6, and 12 months
PROMIS Sleep Disturbance Short Form
Time frame: baseline, 3, 6, and 12 months
Self-Efficacy for Managing Chronic Disease Scale
Time frame: baseline, 3, 6, and 12 months
AUDIT-C and DAST-10 (for alcohol and drug use)
Contact information is provided by the study sponsor or research team.
Companion IQ, Inc
Industry
Evaluating the Effectiveness of a Text/Telephone-Delivered Chatbot Intervention for Chronic Pain Management Among High- Utilizing Veterans
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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