Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
2016年2月11日 更新者：Children's Hospital Medical Center, Cincinnati
Study of the Usage, Usability, Acceptability, and Effect on Adherence and Clinical Outcomes of a Web Based Text Messaging System for Adolescents With Asthma- Phase 2
The purpose of this randomized crossover study is to determine the efficacy of participant designed medication reminders on asthma control, asthma related quality of life,and medication adherence.
In addition, this study will provide data regarding the usage, usability, acceptability of an online system designed for creating text message reminders.
It is hypothesized that the teens receiving text message reminders will report having greater quality of life related to their asthma, a reported increase in the control of their asthma, and increased adherence to their medication regimen compared to those teens that are not receiving the text message reminders.
調査の概要
詳細な説明
Adolescents are typically less adept at managing chronic illnesses and adhering to treatment plans than are parents of younger children.
Adolescents are also typically "early adopters" to technological solutions and text messages are integral in today's teen culture.
Text messages are gaining acceptance in health care both as appointment reminders and direct inquiries.
The purpose of this randomized crossover study is to examine the effect of participant designed medication reminders on asthma control, asthma related quality of life, and medication adherence.
In addition, this study will provide data regarding the usage, usability, and acceptability of an online system designed for creating text message reminders.
研究の種類
介入
入学 (実際)
61
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45229
- Cincinnati Children's Hospital Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～22年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Between the ages of 12 and 22
- Diagnosis of Persistent Asthma
- Receiving care at Cincinnati Children's Hospital Medical Center or affiliate
- Prescription of a controller medication
- Must have a cell phone that receives text messages
- Asthma is not well-controlled based on ACT score
- English Speaking
Exclusion Criteria:
- No diagnosis of persistent asthma
- Receiving asthma care other than at a Cincinnati Children's Hospital Medical Center or affiliate
- Asthma is well-controlled based on ACT score
- Does not have a cell phone that receives text messages or plans to change phones within the next 6 months
- Is not taking a daily asthma controller medication
- Is currently receiving asthma appointment or medication reminder text messages from another source
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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：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 |
|---|---|
|
介入なし：Comparison 1st
Not enrolled in the CMSText website text messaging system during last 3 months of study participation.
|
|
|
実験的：Participant 1st
Enrollment in the CMSText website text messaging system during first 3 months of study participation.
|
During baseline (Participant 1st Arm) or Month 3 Visit (Comparison 1st Arm), the study staff member will demonstrate for the teen how to log-on to the calendar system and set up reminders.
Teens will be able to set their own reminders and add other reminders in addition to those that are asthma related.
|
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 |
|---|---|---|
|
Asthma Control Test (ACT)
時間枠：Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
|
The teen will complete the Asthma Control Test (ACT), a validated 5-item Likert scale test that asks them to detail their asthma symptoms.
These are questions consistent with those that would be asked by a clinician (i.e., how many times have you used your fast-acting inhaler in the past four weeks, how often does asthma limit your activities).
The responses to these questions will also be used to calculate the teen's asthma control.
|
Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)
時間枠：Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
|
This assessment measures how much asthma has been a problem for them in the last month (i.e., "It is hard for me to be responsible for my medications.",
"I worry about my asthma.")
|
Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
|
|
Adherence
時間枠：Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
|
Adherence to medication regimen will be monitored with the Smartinhaler Tracker developed by Nexus 6 ltd.
It will record the adherence to medication administered through metered-dose inhalers, which include medication such as Qvar and Flovent.
The Smartinhaler records the time and date medications were taken, whether the canister was shaken appropriately prior to inhalation, and how much the medication was inhaled.
|
Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Maria T Britto, M.D., M.P.H.、Children's Hospital Medical Center, Cincinnati
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年11月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2012年12月1日
試験登録日
最初に提出
2010年11月29日
QC基準を満たした最初の提出物
2010年12月2日
最初の投稿 (見積もり)
2010年12月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年2月12日
QC基準を満たした最後の更新が送信されました
2016年2月11日
最終確認日
2016年2月1日
詳しくは
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。