DockTales for Chronic Pain
Evaluating Feasibility and Acceptability of DockTales for Chronic Pain
調査の概要
詳細な説明
This is a fully remote, randomized crossover pilot clinical trial designed to evaluate the feasibility and acceptability of DockTales among adults with chronic pain. Chronic pain is defined as pain lasting for more than 3 months. A total of up to 60 participants will be enrolled.
Participants will be randomized in a 1:1 ratio to one of two study sequences. Participants assigned to Sequence 1 will complete 2 weeks of DockTales use followed by 2 weeks of REDCap-based daily monitoring. Participants assigned to Sequence 2 will complete 2 weeks of REDCap-based daily monitoring followed by 2 weeks of DockTales use. All participants will complete both study conditions.
Participants will complete questionnaires at baseline, after the first 2-week period, and after the second 2-week period. These assessments will evaluate feasibility, acceptability, usability, burden, engagement, technical issues, participant preference, and exploratory pain and sleep-related outcomes. Some participants may also complete an optional remote semi-structured interview after finishing both study conditions.
The primary outcomes are feasibility and acceptability. Feasibility will be assessed through recruitment, retention, adherence, completion of DockTales use, completion of REDCap monitoring, missing data, and technical issues. Acceptability will be assessed through satisfaction, engagement, perceived usefulness, ease of use, burden, willingness to use DockTales again, and preference between DockTales and REDCap monitoring.
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：Yang Wang, PhD
- 電話番号：410-706-7824
- メール：yang.wang@umaryland.edu
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland Baltimore School of Nursing
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主任研究者：
- Yang Wang, PhD
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コンタクト：
- Yang Wang
- 電話番号：410-706-7824
- メール：yang.wang@umaryland.edu
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コンタクト：
- Rachel Massalee, MS
- 電話番号：410-706-7824
- メール：rmassalee@umaryland.edu
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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:
- Age ( 18-88 years old)
- English speaker (written and spoken)
- Chronic pain for at least 3 months
- Smartphone/text messaging capability
Exclusion Criteria:
- Any personal history of mania, schizophrenia, or other psychoses
- Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
- Pregnancy or breast feeding
- Impaired or uncorrected hearing
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：DockTales first
This is a crossover-designed study with one arm of chronic pain participants.
All participants will complete both active (DockTales) and control (REDCap) interventions in a randomized sequence.
The first arm will complete 2 weeks of DockTales first, and 2 weeks of REDCap monitoring
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DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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|
他の：REDCap first
This is a crossover-designed study.
Participants in this arm will start with 2 weeks of REDCap monitoring, followed by 2 weeks of DockTales use
|
DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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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 |
|---|---|---|
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Enrollment rate
時間枠：At the enrollment
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Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
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At the enrollment
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Retention rate
時間枠：End of Week 4
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Retention rate: the proportion (%) of enrolled participants who finished the study
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End of Week 4
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Module completion rate
時間枠：End of Week 4
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Module rate: the proportion (%) of completed modules in the DockTales app.
The DockTales app contains 1) daily monitoring module; 2) navigation map module; 3) AI avatar companion module; and 4) daily dairy module.
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End of Week 4
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Daily survey completion rate
時間枠：End of Week 4
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Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
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End of Week 4
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Levels of satisfaction
時間枠：End of Week 2 and Week 4
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Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied.
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End of Week 2 and Week 4
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Levels of enjoyment
時間枠：End of Week 2 and Week 4
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Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed.
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End of Week 2 and Week 4
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Levels of engagement
時間枠：End of Week 2 and Week 4
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Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged.
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End of Week 2 and Week 4
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- HP-00119506
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。