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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Henrik Scheel
- 電話番号:650 804-5000
- メール:henrik@companioniq.org
研究場所
-
-
Georgia
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Augusta、Georgia、アメリカ、30904
- 募集
- VA Augusta Health Care System
-
コンタクト:
- Lisa Parker, MD
- 電話番号:(706) 733-0188
- メール:lisa.parker1@va.gov
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コンタクト:
- Raji Ponnala
- メール:Rajeshwari.Ponnala@va.gov
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:My AI Companion
|
My AI Companion is an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability
時間枠:baseline, 3, 6, and 12 months
|
Net Promoter Score
|
baseline, 3, 6, and 12 months
|
|
Feasibility of Engagement
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity, Enjoyment of life, General activity
時間枠:baseline, 3, 6, and 12 months
|
PEG Scale (Pain intensity, Enjoyment of life, General activity)
|
baseline, 3, 6, and 12 months
|
|
Pain Interference
時間枠:baseline, 3, 6, and 12 months
|
PROMIS Pain Interference Short Form
|
baseline, 3, 6, and 12 months
|
|
Loneliness
時間枠:baseline, 3, 6, and 12 months
|
UCLA Loneliness Scale (short form)
|
baseline, 3, 6, and 12 months
|
|
Veteran-specific health-related quality of life
時間枠:baseline, 3, 6, and 12 months
|
VR-12 (Veteran-specific health-related quality of life)
|
baseline, 3, 6, and 12 months
|
|
Depression and Anxiety
時間枠:baseline, 3, 6, and 12 months
|
PROMIS Depression and Anxiety Short Forms
|
baseline, 3, 6, and 12 months
|
|
Sleep Disturbance Short Form
時間枠:baseline, 3, 6, and 12 months
|
PROMIS Sleep Disturbance Short Form
|
baseline, 3, 6, and 12 months
|
|
Self-Efficacy for Managing Chronic Disease Scale
時間枠:baseline, 3, 6, and 12 months
|
Self-Efficacy for Managing Chronic Disease Scale
|
baseline, 3, 6, and 12 months
|
|
Alcohol and drug use
時間枠:baseline, 3, 6, and 12 months
|
AUDIT-C and DAST-10 (for alcohol and drug use)
|
baseline, 3, 6, and 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。