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Mobile Health Application for Diabetes

17. Oktober 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

20

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Sonstiges: 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.
Verhalten: capABILITY
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).
Sonstiges: 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.
Verhalten: capABILITY
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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Zeitfenster: 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.
9 Weeks
20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Zeitfenster: 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.
Zeitfenster: 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.
9 Weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.
9 Weeks
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.
Zeitfenster: 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.
9 Weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of South Alabama

Ermittler

  • Hauptermittler: Scott Sittig, PhD, University of South Alabama

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2015

Primärer Abschluss (Tatsächlich)

1. Januar 2017

Studienabschluss (Tatsächlich)

1. April 2017

Studienanmeldedaten

Zuerst eingereicht

8. Oktober 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Oktober 2019

Zuerst gepostet (Tatsächlich)

18. Oktober 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Oktober 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Oktober 2019

Zuletzt verifiziert

1. Oktober 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1122 (Jian-jun Li)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

The participant data from this study will not be shared with other researchers. Findings of the study will be published however.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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