VETERANS AFFAIRS AUGUSTA
17 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
200
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Henrik Scheel
- Telefoonnummer: 650 804-5000
- E-mail: henrik@companioniq.org
Studie Locaties
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Georgia
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Augusta, Georgia, Verenigde Staten, 30904
- Werving
- VA Augusta Health Care System
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Contact:
- Lisa Parker, MD
- Telefoonnummer: (706) 733-0188
- E-mail: lisa.parker1@va.gov
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Contact:
- Raji Ponnala
- E-mail: Rajeshwari.Ponnala@va.gov
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: My AI Companion
|
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acceptability
Tijdsspanne: baseline, 3, 6, and 12 months
|
Net Promoter Score
|
baseline, 3, 6, and 12 months
|
|
Feasibility of Engagement
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain intensity, Enjoyment of life, General activity
Tijdsspanne: baseline, 3, 6, and 12 months
|
PEG Scale (Pain intensity, Enjoyment of life, General activity)
|
baseline, 3, 6, and 12 months
|
|
Pain Interference
Tijdsspanne: baseline, 3, 6, and 12 months
|
PROMIS Pain Interference Short Form
|
baseline, 3, 6, and 12 months
|
|
Loneliness
Tijdsspanne: baseline, 3, 6, and 12 months
|
UCLA Loneliness Scale (short form)
|
baseline, 3, 6, and 12 months
|
|
Veteran-specific health-related quality of life
Tijdsspanne: baseline, 3, 6, and 12 months
|
VR-12 (Veteran-specific health-related quality of life)
|
baseline, 3, 6, and 12 months
|
|
Depression and Anxiety
Tijdsspanne: baseline, 3, 6, and 12 months
|
PROMIS Depression and Anxiety Short Forms
|
baseline, 3, 6, and 12 months
|
|
Sleep Disturbance Short Form
Tijdsspanne: baseline, 3, 6, and 12 months
|
PROMIS Sleep Disturbance Short Form
|
baseline, 3, 6, and 12 months
|
|
Self-Efficacy for Managing Chronic Disease Scale
Tijdsspanne: baseline, 3, 6, and 12 months
|
Self-Efficacy for Managing Chronic Disease Scale
|
baseline, 3, 6, and 12 months
|
|
Alcohol and drug use
Tijdsspanne: baseline, 3, 6, and 12 months
|
AUDIT-C and DAST-10 (for alcohol and drug use)
|
baseline, 3, 6, and 12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2026
Primaire voltooiing (Geschat)
1 augustus 2028
Studie voltooiing (Geschat)
1 augustus 2028
Studieregistratiedata
Eerst ingediend
7 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 augustus 2026
Eerst geplaatst (Werkelijk)
20 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Veterans Affairs: Augusta
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
IPD will only be shared when appropriate approvals are in place and applicable privacy and data-sharing requirements have been met
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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