Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The aim of this study is to test the effectiveness of a smartphone based application (APP) on improvement of patients' adherence to medications after coronary artery bypass grafting.
DESIGN AND PROCEDURES The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent coronary artery bypass grafting in 2015, and randomized to either the intervention group or the control group, to test the effectiveness of a smartphone based APP focusing on improving patients medication adherence. Patients randomized to the intervention group install the APP and are intervened by it. The patients randomized to control group receive usual care. The investigators follow up patients in both groups by face to face or telephone interview at 3-month and 6-month after randomization. The 6-month effects of the intervention are evaluated.
The APP contains education materials about secondary prevention of coronary artery disease, patients can surf and read easily. The APP also collects information on medication prescription by doctors, reminds patients at every time of taking medications, and asks for feedback at 8 pm everyday. The APP also pushes one patient-specific questionnaire with 10-15 questions weekly, to collect information about patients' medication adherence and self-administration on blood pressure, blood lipid, glucose, physical activity, diet and body weight. APP will push series of recommendations right after patients' finishing the questionnaire to help them improve secondary prevention.
The coordinators from participating sites interview patients at the baseline, 3-month and 6-month after the randomization, for information of medication adherence, major events and outcomes after coronary artery bypass grafting and quality of life. The primary outcome measure is the Chinese version of the 8-item Morisky medication adherence scale which has already been validated in Chinese population.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Werving
- China National Center for Cardiovascular Diseases
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Underwent coronary artery bypass grafting in 2015
Exclusion Criteria:
- Does not use a smartphone
- Can not install the study specific APP into his/her smartphone
- Does not use 3 or more applications installed in his/her smartphone
- Is incapable to understand texts in Chinese
- Can not type numbers in his/her smartphone
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Controlegroep
Gebruikelijke zorg
|
|
|
Experimenteel: Intervention group
APP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications
|
The APP contains education materials about secondary intervention of coronary artery disease, patients can surf and read them very easily.
The APP also collects information on medication prescription by doctors, reminds patients at every time of taking medications, and asks for feedback from patients at 8 pm every day.
The APP also pushes a patient-specific questionnaire with 10-15 questions weekly, to collect information about patients' medication adherence and self-management on blood pressure, blood lipid, blood glucose, physical activity, diet and body weight.
APP pushes series of recommendations right after patients' finishing the questionnaire to help them improve their secondary prevention.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8)
Tijdsspanne: 6 months
|
patients' medication adherence measured by C-MMAC-8 at 6-month after randomization, the scale of more than 7 is defined as adherence to medications
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medication adherence measured by C-MMAC-8
Tijdsspanne: 3 month
|
patients' medication adherence measured by C-MMAC-8 at 3-month after randomization, the scale of more than 7 is defined as adherence to medications
|
3 month
|
|
mortality at 6-month
Tijdsspanne: 6 months
|
6 months
|
|
|
mortality at 3-month
Tijdsspanne: 3 months
|
3 months
|
|
|
rate of major adverse cardiovascular or cerebral events at 6-month
Tijdsspanne: 6 months
|
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
|
6 months
|
|
rate of major adverse cardiovascular or cerebral events at 3-month
Tijdsspanne: 3 months
|
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
|
3 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
pill count
Tijdsspanne: 6 months
|
the number of tablets remaining divided by the number of tablets prescribed
|
6 months
|
|
pill count
Tijdsspanne: 3 month
|
the number of tablets remaining divided by the number of tablets prescribed
|
3 month
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Shengshou Hu, MD, PhD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
- Hoofdonderzoeker: Zhe Zheng, MD, PhD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
Publicaties en nuttige links
Algemene publicaties
- Yan J, You LM, Yang Q, Liu B, Jin S, Zhou J, Lin C, Morisky DE. Translation and validation of a Chinese version of the 8-item Morisky medication adherence scale in myocardial infarction patients. J Eval Clin Pract. 2014 Aug;20(4):311-7. doi: 10.1111/jep.12125. Epub 2014 May 10.
- Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
- Liu CY, Du JZ, Rao CF, Zhang H, Liu HN, Zhao Y, Yang LM, Li X, Li J, Wang J, Wang HS, Liu ZG, Cheng ZY, Zheng Z. Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2). Chin Med J (Engl). 2018 Jun 20;131(12):1480-1489. doi: 10.4103/0366-6999.233767.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- MOST-2013BAI09B01-3
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .