A Mobile Phone Based Medication Reminder Program
27 gennaio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
49
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
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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).
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: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Mobile App Group
Participants in the experimental group will receive daily reminders and educational materials from mobile applications.
|
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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Comparatore attivo: Control Group
The control group will receive the same educational materials, but no daily reminder.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in medication adherence score
Lasso di tempo: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
|
Percent of prescribed antihypertensive drugs taken during the past three days.
|
baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
|
|
Change in systolic blood pressure (SBP)
Lasso di tempo: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
|
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 diastolic blood pressure (DBP)
Lasso di tempo: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
|
baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility as measured by patient enrollment
Lasso di tempo: 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
|
|
Feasibility as measured by patient retention
Lasso di tempo: 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
Lasso di tempo: approximately seven weeks
|
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.
|
approximately seven weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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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
11 luglio 2016
Completamento primario (Effettivo)
19 settembre 2016
Completamento dello studio (Effettivo)
12 novembre 2016
Date di iscrizione allo studio
Primo inviato
3 giugno 2016
Primo inviato che soddisfa i criteri di controllo qualità
7 giugno 2016
Primo Inserito (Stima)
8 giugno 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
30 gennaio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 gennaio 2017
Ultimo verificato
1 gennaio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00073395
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .
Prove cliniche su Daily reminders of taking medications
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