Feasibility and effectiveness assessment of a mobile application for subhealth management : Study protocol for a randomized controlled trial

INTRODUCTION: Mibyeongbogam (MBBG) is a mobile application developed for subhealth status self-management in the Republic of Korea. It aims to assess a user's subhealth status, and then to recommend relevant traditional Korean medicine (TKM)-based health-promoting strategies. The purpose of this study is to evaluate the feasibility and effectiveness of MBBG's employment for the subhealth management of general healthy adults.

METHODS: This is a prospective, open-label, parallel group, randomized controlled trial that will seek to enroll 150 healthy adults, aged 30 to 49 years old, from 2 hospitals in the Republic of Korea. The eligible participants will then be randomly allocated to either the MBBG or control group, at a 1:1 allocation ratio. The MBBG group will use the application for 12 weeks, while the control group will undergo no intervention. The awareness of subhealth status will be primarily assessed. Health promoting behaviors, quality of life, TKM-based health questionnaires, and physical examination results will be assessed as secondary outcomes.

DISCUSSION: The primary endpoint will be tested with a 2-sample t test, or a Wilcoxon rank sum test. Any other continuous variables will be tested via an analysis of covariance, while categorical variables will be tested by a Chi-squared or Fisher exact test. Repeated measure analysis of variance will be performed to explore any in-group differences. The results will be addressed with a 95% confidence interval. We expect that MBBG will be the 1st TKM-based mobile application to be feasible for primary care in subhealth management.

TRIAL REGISTRATION: CRIS (Clinical Research Information Service), KCT0003488, February 11, 2019.

Medienart:

E-Artikel

Erscheinungsjahr:

2019

Erschienen:

2019

Enthalten in:

Zur Gesamtaufnahme - volume:98

Enthalten in:

Medicine - 98(2019), 21 vom: 10. Mai, Seite e15704

Sprache:

Englisch

Beteiligte Personen:

Shin, Seungwon [VerfasserIn]
Oh, Hyunjoo [VerfasserIn]
Kang, Minsu [VerfasserIn]
Park, Minyoung [VerfasserIn]
Koh, Byung-Hee [VerfasserIn]
Hwang, Minwoo [VerfasserIn]

Links:

Volltext

Themen:

Biomarkers
Clinical Trial Protocol
Journal Article

Anmerkungen:

Date Completed 10.06.2019

Date Revised 21.03.2024

published: Print

Citation Status MEDLINE

doi:

10.1097/MD.0000000000015704

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM297430998