RECOVER-ENERGIZE プラットフォーム プロトコル_付録 B (構造化ペーシング (PEM))
RECOVER-ENERGIZE: SARS-CoV-2 感染症の急性後遺症 (PASC) における運動不耐症に対する介入を評価するためのプラットフォーム プロトコル
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).
The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.
調査の概要
詳細な説明
Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence.
The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- All sites listed under NCT06404047
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix
Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria:
- Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
- Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND Answer of YES to either item 7 or 8 on Screening mDSQ-PEM, and response of >14 h in item 9.
or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of >14h in item 9.
Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria:
- Inability to attend in-person screening visit or participate in weekly visits (in-person [≥ 1] and remote)
- Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A
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：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 |
|---|---|
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実験的：Structured Pacing (PEM)
Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications. |
Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications. |
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他の：Usual Care
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
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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Change in Frequency of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)
時間枠：Baseline, week 12 (End Of Intervention, EOI)
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Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. |
Baseline, week 12 (End Of Intervention, EOI)
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Change in Severity of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)
時間枠：Baseline, week 12 (EOI)
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Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. |
Baseline, week 12 (EOI)
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Change in Duration of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)
時間枠：Baseline, week 12 (EOI)
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Ordinal categorical response: <=1 hour, 2-3 hours, 4-10 hours, 11-13 hours, 14-23 hours, >=24 hours. Reported as the number of participants who provided each response. |
Baseline, week 12 (EOI)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in PASC Symptoms, as Measured by the PROMIS-Cog Questionnaire
時間枠：Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PROMIS Short Form v.2.0 - Cognitive Function 8a (PROMIS-Cog) is the PROMIS Short Form to assess cognitive function and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. T-Scores in a healthy reference population have mean=50 and standard deviation = 10, with higher scores indicating higher functioning. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Quality of Life, as Measured by the PROMIS-29+2
時間枠：Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Quality of Life, as Measured by the EQ-5D 5L
時間枠：Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The EQ-5D is a standardized measure of health status. Mobility was measured on a scale from 1 (no problems in walking) to 5 (unable to walk). |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Step Count (Physical Activity) as Measured by Actigraphy
時間枠：Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Actigraphy will be measured by Fitbit. Participant steps were considered valid from days where they wore the Fitbit at least 10 waking hours. Average steps were calculated from subjects with at least 5 consecutive days of valid data within a week window of their expected visit dates. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Physical Activity, as Measured by the PROMIS SF-Physical Function (PROMIS-PF)
時間枠：Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. T-Scores in a healthy reference population have mean = 50 and standard deviation = 10, with higher scores indicating higher functioning. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Orthostatic Hypotension, as Measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)
時間枠：Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The Orthostatic Hypotension Questionnaire (OHQ) is a measure of orthostatic intolerance. The modified OHQ (mOHQ) measure used in this study includes a total of ten items related to daily activities and symptoms. The OHQ composite score ranges from 0 (no burden) to 10 (maximal burden). Higher scores are worse. The OHQ composite score includes 6 symptom items (OISA) and 4 daily activity items (OIDAS). |
Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in PASC Symptoms, as Measured by the PASC Symptom Questionnaire
時間枠：Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PASC Symptom Questionnaire is a 33-question survey for self-reporting multiple PASC-related symptoms across multiple systems. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Gary M Felker, MD、Duke Clinical Research Institute
- スタディチェア：Barry Make, MD、National Jewish Health
- スタディチェア：Lucinda Bateman, MD、Bateman Horne Center
- スタディチェア：Janna Friedly, MD, MPH、University of Washington
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00112409_B
- OT2HL156812 (米国 NIH グラント/契約)
- NHLBI Grant to RTI (その他の助成金/資金番号：RTI subcontracting with DCRI)
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
The summary of the results will be shared on the study website: https://recovercovid.org/
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。