A Mobile Phone Based Medication Reminder Program
27. Januar 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
49
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
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in medication adherence score
Zeitfenster: 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)
Zeitfenster: 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.
|
|
|
Change in diastolic blood pressure (DBP)
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility as measured by patient enrollment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: approximately seven weeks
|
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.
|
approximately seven weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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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
11. Juli 2016
Primärer Abschluss (Tatsächlich)
19. September 2016
Studienabschluss (Tatsächlich)
12. November 2016
Studienanmeldedaten
Zuerst eingereicht
3. Juni 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Juni 2016
Zuerst gepostet (Schätzen)
8. Juni 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
30. Januar 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Januar 2017
Zuletzt verifiziert
1. Januar 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00073395
Plan für individuelle Teilnehmerdaten (IPD)
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