- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07776600
VETERANS AFFAIRS AUGUSTA
Evaluating the Effectiveness of a Text/Telephone-Delivered Chatbot Intervention for Chronic Pain Management Among High- Utilizing Veterans
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Henrik Scheel
- Telefonnummer: 650 804-5000
- E-mail: henrik@companioniq.org
Studiesteder
-
-
Georgia
-
Augusta, Georgia, Forenede Stater, 30904
- Rekruttering
- VA Augusta Health Care System
-
Kontakt:
- Lisa Parker, MD
- Telefonnummer: (706) 733-0188
- E-mail: lisa.parker1@va.gov
-
Kontakt:
- Raji Ponnala
- E-mail: Rajeshwari.Ponnala@va.gov
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:Participants must meet all of the following eligibility criteria to be enrolled in the study:
- Be a Veteran receiving care at the VA Augusta Health Care System Pain Medicine Service.
- Be aged 18 or older.
- Have a documented diagnosis of chronic pain (defined as pain persisting longer than 3 months).
- Be classified as a high utilizer of VA in-person outpatient services, defined as having 4 or more in-person primary care, behavioral health, or pain-related visits within the past 6 months.
- Be English-speaking.
- Have access to a telephone (landline or cell phone).
- Have capacity to provide informed consent.
Exclusion Criteria:
Individuals will be excluded from the study if they:
- Have moderate to severe cognitive impairment that would interfere with the ability to engage with a text/telephone-based chatbot (as determined through medical record review or clinical judgment).
- Have active psychosis or acute psychiatric instability (e.g., recent psychiatric hospitalization in the past month) that would impair study participation.
- Are enrolled in another conflicting behavioral intervention study.
- Are non-English speaking, due to the current availability of the chatbot only in English.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: My AI Companion
|
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability
Tidsramme: baseline, 3, 6, and 12 months
|
Net Promoter Score
|
baseline, 3, 6, and 12 months
|
|
Feasibility of Engagement
Tidsramme: baseline, 3, 6, and 12 months
|
Measure feasibility through enrollment, retention, and chatbot engagement data (e.g., number of interactions, session duration).
|
baseline, 3, 6, and 12 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity, Enjoyment of life, General activity
Tidsramme: baseline, 3, 6, and 12 months
|
PEG Scale (Pain intensity, Enjoyment of life, General activity)
|
baseline, 3, 6, and 12 months
|
|
Pain Interference
Tidsramme: baseline, 3, 6, and 12 months
|
PROMIS Pain Interference Short Form
|
baseline, 3, 6, and 12 months
|
|
Loneliness
Tidsramme: baseline, 3, 6, and 12 months
|
UCLA Loneliness Scale (short form)
|
baseline, 3, 6, and 12 months
|
|
Veteran-specific health-related quality of life
Tidsramme: baseline, 3, 6, and 12 months
|
VR-12 (Veteran-specific health-related quality of life)
|
baseline, 3, 6, and 12 months
|
|
Depression and Anxiety
Tidsramme: baseline, 3, 6, and 12 months
|
PROMIS Depression and Anxiety Short Forms
|
baseline, 3, 6, and 12 months
|
|
Sleep Disturbance Short Form
Tidsramme: baseline, 3, 6, and 12 months
|
PROMIS Sleep Disturbance Short Form
|
baseline, 3, 6, and 12 months
|
|
Self-Efficacy for Managing Chronic Disease Scale
Tidsramme: baseline, 3, 6, and 12 months
|
Self-Efficacy for Managing Chronic Disease Scale
|
baseline, 3, 6, and 12 months
|
|
Alcohol and drug use
Tidsramme: baseline, 3, 6, and 12 months
|
AUDIT-C and DAST-10 (for alcohol and drug use)
|
baseline, 3, 6, and 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Veterans Affairs: Augusta
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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