嚢胞性線維症の青年および若年成人の身体活動を促進するパーソナライズされたモバイルヘルスプラットフォーム (NUDGE)
The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity
Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:
- Set and review goals
- Self-monitor progress
- Provide feedback on goal attainment
- Revise future goals
調査の概要
詳細な説明
The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving NUDGE will then begin receiving intervention content for 6 months. AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit. Study visits will occur at Months 0, 3, and 6 with staff masked to treatment assignment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Florida
-
Jacksonville、Florida、アメリカ、32207
- Nemours Childrens Health
-
-
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
Inclusion Criteria:
- 13-25 years old
- Has a verified CF diagnosis or CF-related disorder
- Medically stable (i.e., FEV1>30%, not experiencing a CF-related exacerbation)
- Speaks and reads English
Exclusion Criteria:
- Have a comorbidity limiting PA participation (e.g., neurological condition)
- Have a significant cognitive impairment that interferes with study completion
- Have any oxygen, CPAP or BiPAP requirement
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 |
|---|---|
|
アクティブコンパレータ：教育
|
Individuals will receive educational materials about how to increase physical activity |
|
実験的：ナッジ
|
Individuals in this condition will receive intervention content to promote physical activity. |
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 |
|---|---|---|
|
Recruitment
時間枠：Baseline
|
Recruitment: Our recruitment goal is 30 AYAs with CF. |
Baseline
|
|
Retention
時間枠：3-month
|
Retention: Our criterion for success is no more than 20% attrition. |
3-month
|
|
Engagement
時間枠：3-month
|
Engagement: We will be considered engagement a success if AYAs in NUDGE respond to an average of 4/7 (57%) messages each week during the first 3 months that a participant uses NUDGE. |
3-month
|
|
Acceptability
時間枠：3-month
|
Acceptability: We will consider NUDGE acceptable if users report a satisfaction rating of ≥3 (mostly satisfied) on our modified Client Satisfaction Questionnaire and rate it as usable as ≥70% of other computerized systems on the System Usability Scale. We will also be attentive to themes in relation to the barriers and facilitators of using NUDGE and its success in promoting PA in interviews. |
3-month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Actigraphy
時間枠：Baseline, 3-month, and 6-month
|
We will objectively measure AYA's moderate-to-vigorous PA for 7-days via ActiGraph wGT3X-BT accelerometers. All data will be processed using Actilife software. We will remove periods of non-wear and sleep; days with >10-hours of valid data during waking hours will be retained. Data will be binned into 15 second epochs and processed using the Chandler algorithm. |
Baseline, 3-month, and 6-month
|
|
Lung Functioning
時間枠：Baseline, 3-month, and 6-month
|
Lung function will be assessed for 7-days via the AM1+ portable spirometer. AYAs will undergo a standardize training and complete three maximal effort blows every morning and evening. The main outcomes will be forced expiratory volume in one second (FEV1) percent predicted. |
Baseline, 3-month, and 6-month
|
|
CF Quality of Life
時間枠：Baseline, 3-month, and 6-month
|
AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised. |
Baseline, 3-month, and 6-month
|
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2158063
- 003780A122 (その他の助成金/資金番号：Cystic Fibrosis Foundation)
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
Plans to share IPD will need to be discussed with the IRB.
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
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