- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Henrik Scheel
- Telefonnummer: 650 804-5000
- E-post: henrik@companioniq.org
Studiesteder
-
-
Georgia
-
Augusta, Georgia, Forente stater, 30904
- Rekruttering
- VA Augusta Health Care System
-
Ta kontakt med:
- Lisa Parker, MD
- Telefonnummer: (706) 733-0188
- E-post: lisa.parker1@va.gov
-
Ta kontakt med:
- Raji Ponnala
- E-post: Rajeshwari.Ponnala@va.gov
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: My AI Companion
|
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Veterans Affairs: Augusta
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .