Mobile Health Application for Diabetes
17. oktober 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: 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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Annen: 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).
|
|
Annen: 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Scott Sittig, PhD, University of South Alabama
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2015
Primær fullføring (Faktiske)
1. januar 2017
Studiet fullført (Faktiske)
1. april 2017
Datoer for studieregistrering
Først innsendt
8. oktober 2019
Først innsendt som oppfylte QC-kriteriene
17. oktober 2019
Først lagt ut (Faktiske)
18. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1122 (Jian-jun Li)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The participant data from this study will not be shared with other researchers.
Findings of the study will be published however.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .