A Mobile Phone Based Medication Reminder Program
27 januari 2017 bijgewerkt door: Duke University
A Mobile Phone Based Medication Reminder Program for Patients in China With Coronary Heart Disease: A Pilot Study
This study evaluates the feasibility and acceptability of using mobile applications to improve medication adherence.
Participants in the experimental group will receive educational materials and daily reminders through mobile applications.
While, participants in the control group will receive only educational materials.
After the intervention, interviews will be conducted among participants through phone calls.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study is to improve medication adherence for Chinese patients with coronary heart disease (CHD) by using mobile applications.
An exploratory randomized controlled trial (RCT, N=49) and interviews (n=15) will be included in this pilot study.
The RCT will compare the effects of the medication adherence (MA, n=24) intervention and control condition (n=25) on the MA score (percent of prescribed antihypertensive drugs taken), and health outcomes (SBP and DBP obtained) of patients.
The health outcomes will be assessed at enrollment and every three days after the intervention begins for thirty days.
Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through focus group interviews.
All analyses will be performed using SAS 9.3 (Cary, NC).
The potential risks of this study are minimal.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
49
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion criteria for participants are:
- having a medical diagnosis of CHD
- being eighteen years old or older
- having an antihypertensive medication regimen that lasts for forty-nine days or more at the enrollment
- being able to read messages through mobile phone
- having a mobile phone which can receive messages from WeChat, and can receive daily reminders from BB Reminder
- having no obvious cognitive impairment
- patients with comorbidities can be included in the study, but during the study, antihypertensive medications are their only prescribed medications (this will be screened by the cardiologist).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Mobile App Group
Participants in the experimental group will receive daily reminders and educational materials from mobile applications.
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Reminders.
Participants will receive medication-taking reminders from the researcher.
These reminders are sent through the mobile application-BB Reminder on an unencrypted external device (a phone borrowed from Duke University School of Nursing and is used specifically for this study by the researcher).
BB Reminder has the function that after inputting a patient's phone number and prescriptions, participants can receive reminders through text messages of the name, dosage, function, and administration route for every dose of his/her medications.
The daily reminders will be sent to participants 15 minutes before every dose of their medications.
Educational materials.
Participants will receive educational materials from the researcher.
These educational materials will be sent through the mobile application-WeChat.
The educational materials include short articles (< 500 words) and/or pictures.
They will be retrieved from the Chinese Cardiovascular Disease-Prevention Information Website (www.healthyheart-china.com), which is governed by the Chinese Ministry of Health.
The validity of information from it is guaranteed.
The retrieved educational materials will be screened by the cardiologist, the head nurse, and the researcher, before sending to participants.
The educational materials will be sent to participants every other day at any time during 8 am and 10 pm.
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Actieve vergelijker: Control Group
The control group will receive the same educational materials, but no daily reminder.
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Educational materials.
Participants will receive educational materials from the researcher.
These educational materials will be sent through the mobile application-WeChat.
The educational materials include short articles (< 500 words) and/or pictures.
They will be retrieved from the Chinese Cardiovascular Disease-Prevention Information Website (www.healthyheart-china.com), which is governed by the Chinese Ministry of Health.
The validity of information from it is guaranteed.
The retrieved educational materials will be screened by the cardiologist, the head nurse, and the researcher, before sending to participants.
The educational materials will be sent to participants every other day at any time during 8 am and 10 pm.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in medication adherence score
Tijdsspanne: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
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Percent of prescribed antihypertensive drugs taken during the past three days.
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baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
|
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Change in systolic blood pressure (SBP)
Tijdsspanne: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
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baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
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|
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Change in diastolic blood pressure (DBP)
Tijdsspanne: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
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baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility as measured by patient enrollment
Tijdsspanne: approximately seven weeks
|
Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).
|
approximately seven weeks
|
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Feasibility as measured by patient retention
Tijdsspanne: approximately seven weeks
|
Feasibility will be determined by retention (percent of patients who complete the study)
|
approximately seven weeks
|
|
Acceptability as measured by patient interviews
Tijdsspanne: approximately seven weeks
|
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.
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approximately seven weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
11 juli 2016
Primaire voltooiing (Werkelijk)
19 september 2016
Studie voltooiing (Werkelijk)
12 november 2016
Studieregistratiedata
Eerst ingediend
3 juni 2016
Eerst ingediend dat voldeed aan de QC-criteria
7 juni 2016
Eerst geplaatst (Schatting)
8 juni 2016
Updates van studierecords
Laatste update geplaatst (Schatting)
30 januari 2017
Laatste update ingediend die voldeed aan QC-criteria
27 januari 2017
Laatst geverifieerd
1 januari 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00073395
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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