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VETERANS AFFAIRS AUGUSTA

17 augusti 2026 uppdaterad av: Companion IQ, Inc

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: My AI Companion
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptability
Tidsram: baseline, 3, 6, and 12 months
Net Promoter Score
baseline, 3, 6, and 12 months
Feasibility of Engagement
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain intensity, Enjoyment of life, General activity
Tidsram: baseline, 3, 6, and 12 months
PEG Scale (Pain intensity, Enjoyment of life, General activity)
baseline, 3, 6, and 12 months
Pain Interference
Tidsram: baseline, 3, 6, and 12 months
PROMIS Pain Interference Short Form
baseline, 3, 6, and 12 months
Loneliness
Tidsram: baseline, 3, 6, and 12 months
UCLA Loneliness Scale (short form)
baseline, 3, 6, and 12 months
Veteran-specific health-related quality of life
Tidsram: baseline, 3, 6, and 12 months
VR-12 (Veteran-specific health-related quality of life)
baseline, 3, 6, and 12 months
Depression and Anxiety
Tidsram: baseline, 3, 6, and 12 months
PROMIS Depression and Anxiety Short Forms
baseline, 3, 6, and 12 months
Sleep Disturbance Short Form
Tidsram: baseline, 3, 6, and 12 months
PROMIS Sleep Disturbance Short Form
baseline, 3, 6, and 12 months
Self-Efficacy for Managing Chronic Disease Scale
Tidsram: baseline, 3, 6, and 12 months
Self-Efficacy for Managing Chronic Disease Scale
baseline, 3, 6, and 12 months
Alcohol and drug use
Tidsram: baseline, 3, 6, and 12 months
AUDIT-C and DAST-10 (for alcohol and drug use)
baseline, 3, 6, and 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2026

Primärt slutförande (Beräknad)

1 augusti 2028

Avslutad studie (Beräknad)

1 augusti 2028

Studieregistreringsdatum

Först inskickad

7 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2026

Första postat (Faktisk)

20 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • Veterans Affairs: Augusta

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

IPD will only be shared when appropriate approvals are in place and applicable privacy and data-sharing requirements have been met

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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