Mobile Health Application for Diabetes
17 ottobre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
20
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
21 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: 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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Altro: 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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Altro: 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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Lasso di tempo: 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.
Lasso di tempo: 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.
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9 Weeks
|
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20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Scott Sittig, PhD, University of South Alabama
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2015
Completamento primario (Effettivo)
1 gennaio 2017
Completamento dello studio (Effettivo)
1 aprile 2017
Date di iscrizione allo studio
Primo inviato
8 ottobre 2019
Primo inviato che soddisfa i criteri di controllo qualità
17 ottobre 2019
Primo Inserito (Effettivo)
18 ottobre 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 ottobre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 ottobre 2019
Ultimo verificato
1 ottobre 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1122 (Jian-jun Li)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
The participant data from this study will not be shared with other researchers.
Findings of the study will be published however.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .