Randomized Controlled Trial of the Smart O2O Model Development for Chronic Diseases Management Through Digital Health

NCT06150508 | Unknown

• 1 other identifier: IRB No: 2308-183-1463
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives The aim of this intervention is to assess how well and how efficiently the O2O Service Model works in delivering primary healthcare and managing chronic diseases for patients living in Pyeongchang-gun at the local government level. Trial design This is a randomized controlled trial with restricted, batch, blocked and individual random assignment. Investigators will allocate 1,000 participants from Pyeongchang-gun into two groups: one with diabetes (and pre-diabetes) and one with hypertension (including borderline cases), focusing on poorly controlled patients. As participants visit local health centers, their data will be sent to the research team for blocked randomization based on disease type, severity, and region. Assignment results will be communicated back to the centers and patients. Study setting The intervention will take place in Pyeongchang-gun, Kangwon-do, South Korea. The Smart Healthcare Center affiliated to Public Medical Center of Pyeongchang will primarily manage the O2O service by providing necessary education and human resources while receiving and monitoring data from each participant and local medical centers. The overall study (including the design of trial) is managed by Seoul National University College of Medicine while the provision of O2O service and data collection are primarily in charge of Smart Healthcare Center of Pyeongchang. Intervention in O2O Service Model: After initial health exams, each patient gets a custom care plan, classifying their disease and care level. The Pyeongchang Smart Healthcare Center, with doctors, tracks patients via an online platform, sending automated health messages. High-risk patients receive a two-week glucose monitor and guidance on lifestyle adjustments. Doctors access patient health records through the participant's personal online datastore (POD), with consent, integrating health and prescription history from national insurance, and can assess heart disease risk. Sample size The trial's sample size is determined using the MDES(Minimum Detectable Effect Size), with 1,000 participants divided equally between diabetes and hypertension groups. Each group is then split into treatment and control subgroups through random allocation. The MDES calculation, accounting for an explained outcome variation of 50% due to blocking and controls, and based on 500 subjects per group with equal allocation, aims for a high-accuracy effect size of 0.216 at a 5% significance level and 80% power. Assignment of interventions: allocation Participants will be randomly placed into groups by a computer program. This study uses a specific randomization method that is restricted and organized by individual characteristics. The research team will tell the centers and patients about their group assignment via phone and email. Neither the healthcare staff nor the participants will know the group allocation beforehand. The research team is in charge of the randomization process and informing everyone involved. The staff at Pyeongchang's Smart Healthcare Center will sign up participants and manage their placement into the assigned intervention groups. There will be no blinding after participants are assigned to their groups. List of Data For the study, the investigators have created questionnaires and interview formats to collect various data types, including random assignment records, baseline information, outcomes, service usage and costs, demographic and health details, physician-collected health records, life-log data from apps or web, clinical exam results, and service effectiveness and efficiency from the perspective of medical staff and administrators. Statistical methods For the analysis of primary and secondary outcomes, the investigators will employ ITT(Intention-to-Treat) and Regression-Adjusted Impact Estimate. When data allows (especially data from control group), the investigators will also conduct timeseries effect analysis. To investigate the time-series changes in program effects across multiple time points, the dependent variable (outcome variable) should be measured at each time point to estimate program effects repeatedly. Data management and monitoring The data management for the study will be conducted using electronic systems for secure and accurate data entry, coding, and storage, with robust checks and backups to ensure data quality, which will be archived for three years in compliance with bioethics standards before disposal according to privacy regulations. Participant confidentiality is prioritized through secure data collection and restricted access, with sharing only to authorized research team members and regulators using password protection or encryption. Additionally, a dedicated Data Monitoring Committee will oversee trial progress and adherence to protocols, while the Smart Healthcare Center collaborates with healthcare workers to manage patient services, with minimal adverse events expected.

Conditions

Hypertension; Diabete Mellitus

Outcome Measures

Primary Outcomes (4)

• Blood pressure

  Diastolic blood pressure, Systolic blood pressure (mmHg)

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

• Fasting blood glucose level (FBG) in mg/dL

  Glucose level

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

• Glucose level

  HbA1c in percent

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

• Lipid profile

  Cholesterol, Triglyceride(TG), HDL Cholesterol, LDL Cholesterol(All in ㎎/㎗)

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

Secondary Outcomes (5)

• Body measurement

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

• Waist circumference in centimeter

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

• Medication Adherence

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

• Costs of treatment (Healthcare expenditure)

  up to 6 months after for hypertension patient or 9 months after for diabetes patient

• Lifestyle questionnaire

  Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)

Other Outcomes (2)

• Participation rate

  up to 6 months after for hypertension patient or 9 months after for diabetes patient

• Satisfaction rate

  Once at 6 months after for hypertension patient or 9 months after for diabetes patient

Study Arms (2)

Comparative group

NO INTERVENTION

Comparators will not be provided with the O2O service, but will be treated as usual (TAU) through the 1st tier health care clinics/centers in Pyeongchang-gun county.

Intervention group

EXPERIMENTAL

Intervention group will use the service app "Value Health" for life-log recording. They regularly record life-log data such as blood pressure, blood glucose, medication, diet, exercise, and weight. (As mentioned, glucose level and blood pressure measurements will be automatically shared with the app using Bluetooth function of the provided checkers.) Interventions through application include automated message and alarm service through the app, as well as personalized intervention messages, record management, and other interventions from the Smart Healthcare Center and the primary healthcare provider.

Behavioral: O2O digital healthcare service

Interventions

O2O digital healthcare service BEHAVIORAL

The O2O service includes a mobile app and web-based portal that allows patients to monitor their blood glucose levels, track their medication use and physical activity, receive personalized feedback and education, and communicate with healthcare providers. The treatment group will receive a blood sugar checker and blood pressure checker that send the records automatically to the application through Bluetooth.

Also known as: O2O digital healthcare service for patients with diabetes and hypertension

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation aged 18 to 70 years
• Participation diagnosed with diabetes (including borderline diabetes) or hypertension (including borderline hypertension)
• However, we will exercise flexibility in age eligibility, allowing patients above 70 years to participate if they meet the following criteria:
• Digital Literacy: Participants above 70 years must demonstrate proficiency in digital technology and the ability to effectively use the mobile application "Value Health," which has been specially developed for this research.

You may not qualify if:

• Incompatible Mobile Device: Individuals using older mobile phones that are not compatible with the "Value of Health" application will be excluded.
• Non-Acceptance of Random Assignment or Participation: Individuals who do not agree to be randomly assigned to either the treatment or control group or who do not wish to engage in our research program will be excluded from participation.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Health Industry Development Institute: collaborator
• Seoul National University: collaborator

Related Publications (1)

• Shin JE, Choi J, Lee H, Lee SW, Oh J. Protocol paper: randomized controlled trial of the smart online-to-offline model development for chronic diseases management through digital health in real world setting. Trials. 2025 Feb 5;26(1):40. doi: 10.1186/s13063-025-08735-8.

  PMID: 39910545 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Juwhan Oh, MD, PhD

  Seoul National University Hospital & College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juho Choi, MD

CONTACT

01072797401; tmzpdlxld@gmail.com

Hee Jung Lee, BS

CONTACT

01024687863; lhee05182@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 29, 2023
• Study Start: November 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share