Mobile Health Application for Diabetes
2019年10月17日 更新者：Scott Sittig、University of South Alabama
Incorporating Behavioral Trigger Measures Into a Mobile Health (mHealth) App Design for Chronic Disease Management: Pilot Study in Diabetes
Creation of a mobile health application for individuals with type II diabetes.
This application was designed to improve knowledge, self-efficacy and self-care.
The application delivered educational material and provided push notifications (messages).
It also allowed for the participants to key in blood glucose levels, carbohydrate consumption and daily exercise.
調査の概要
詳細な説明
capABILITY (the mobile health application) was designed to cover three main diabetes content areas which the investigators call modules: diet (module 1), exercise (module 2) and self-management (module 3) (i.e. medication adherence, glucose monitoring). The length of the study was 9 weeks in duration with three weeks of content per module. Within each module new material was delivered each week through capABILITY. Essentially, every Monday started a new week's worth of educational material that was intended to last until Sunday. Each participant was randomly assigned to either the control group (no triggers), spark trigger group or facilitator trigger group. At the beginning of each module the participants would be randomly assigned to one of the three aforementioned classification groups (this was a 2-Factor Cross-Over Design).
The investigators utilized the Perceived Diabetes Self-Efficacy Scale , Diabetes Knowledge Test developed by Michigan University, and the Summary of Diabetes Self-Care Activities Measures scale (SDSCA) . All the participants completed the perceived diabetes self-efficacy scale along with the knowledge test and SDSCA Pre/Post intervention. In addition, the participants answered one self-efficacy, knowledge, self-care and goal question at the conclusion of each week within capABILITY.
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
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
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Must be at least 21 years of age or older
- Current diagnosis of type II diabetes
- Must have access to a smartphone and daily internet (WiFi)
Exclusion Criteria:
- Anyone with gestational diabetes
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：他の
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- 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：Control
This was the control group for the messaging component of the study (push notifications).
These participants only received the mobile health application called capABILITY without messages.
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他の：Facilitator Message Group
This group of participants received the mobile health application called capABILITY and received three facilitator messages per week.
Facilitator messages are designed to help people who lack ability to do something.
|
All participants utilized the designed capABILITy application.
The application consisted of education material and persuasive messaging.
There were two types of messaging components named facilitators and sparks.
This created three groups consisting of: control, facilitators and sparks.
Participants spent 1 month in each group (total duration of the study was three months).
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他の：Spark Trigger Group
This group of participants received the mobile health application called capABILITY and received three spark messages per week.
Spark messages are designed to help people who lack ability to do something.
|
All participants utilized the designed capABILITy application.
The application consisted of education material and persuasive messaging.
There were two types of messaging components named facilitators and sparks.
This created three groups consisting of: control, facilitators and sparks.
Participants spent 1 month in each group (total duration of the study was three months).
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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 |
|---|---|---|
|
20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
時間枠：9 Weeks
|
Participants completed the Perceived Diabetes Self-Management Scale at baseline and post intervention to measure their self-efficacy.
The measure (scale) consists of eight questions ranging from strongly disagree (1) to strongly agree (5).
All items are scored so that high scores equals higher perceived self-efficacy.
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9 Weeks
|
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20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
時間枠：9 Weeks
|
Participants completed the Brief Diabetes Knowledge Test (DKT2) at baseline and post intervention to measure their overall type II diabetes knowledge.
The measure (scale) consists of twenty- three multiple choice knowledge questions.
The score was calculated based on the number of questions answered correctly with higher scores representing a higher knowledge level.
|
9 Weeks
|
|
20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
時間枠：9 Weeks
|
Participants completed the Summary of Diabetes Self-Care Activities Questionnaire at baseline and post intervention to measure their diabetes self-care.
The measure (scale) consists of twenty five questions ranging from a score of 1 (days per week) to 7 (days per week).
All items are scored so that high scores equals higher self-care.
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9 Weeks
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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 |
|---|---|---|
|
Participants will login and use capABILITY quicker (time measured in seconds) after receiving a behavioral trigger message than those participants who don't receive a behavioral trigger.
時間枠：9 Weeks
|
Participants will engage quicker with capABILITY after they receive behavioral triggers (Sparks and Facilitators) than those participants who don't receive behavioral triggers.
Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am.
Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY.
The smaller the number in seconds the quicker the login time from push notification delivery.
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9 Weeks
|
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Participants who receive a Spark trigger message will login and use capABILITY quicker (time measured in seconds) than those participants who receive Facilitator trigger message.
時間枠：9 Weeks
|
Participants will engage quicker with capABILITY after they receive Spark trigger messages than those who receive a Facilitator trigger message.
Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am.
Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY.
The smaller the number in seconds the quicker the login time from push notification delivery.
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9 Weeks
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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。
捜査官
- 主任研究者：Scott Sittig, PhD、University of South Alabama
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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 (実際)
2015年1月1日
一次修了 (実際)
2017年1月1日
研究の完了 (実際)
2017年4月1日
試験登録日
最初に提出
2019年10月8日
QC基準を満たした最初の提出物
2019年10月17日
最初の投稿 (実際)
2019年10月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月18日
QC基準を満たした最後の更新が送信されました
2019年10月17日
最終確認日
2019年10月1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?
いいえ
IPD プランの説明
The participant data from this study will not be shared with other researchers.
Findings of the study will be published however.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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