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Effects of FOR-Care Model on Preventive Medicine

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National Taiwan University

Status

Active, not recruiting

Conditions

Hypertension
Family Medicine
Diabetes Mellitus
Body Weight
Preventive Medicine

Treatments

Diagnostic Test: Height, Weight, and Blood Pressure Measurement Procedures Improvement

Study type

Interventional

Funder types

Other

Identifiers

NCT06406192
202402048RIND

Details and patient eligibility

About

This study aims to address the prevalence of undiagnosed hypertension and diabetes by assessing the impact of the FOR-Care model on preventive medicine. The model focuses on improving the documentation of blood pressure, height, and weight in outpatient settings. Through a cluster randomized trial at National Taiwan University Hospital, clinics will either implement the FOR-Care model or continue with usual care. The trial will evaluate the effectiveness of the intervention in documenting these measurements and its impact on diagnosing hypertension and diabetes. The outcomes will provide valuable insights into enhancing preventive medicine and improving care for chronic diseases.

Full description

Background: The prevalence of undiagnosed hypertension and diabetes among adults is considerable. For those already diagnosed with hypertension and diabetes, monitoring blood pressure and controlling body weight are recognized as essential methods for risk assessment. However, in outpatient settings, there is still room for improvement in the on-site documentation of blood pressure, height, and weight.

Objective: This cluster randomized trial (CRT) will assess the effects of preventive medicine following the implementation of the FOR-Care model, a technique designed for facilitating on-site recordings of office blood pressure, height, and weight.

Methods: The investigators will conduct a pragmatic CRT at the outpatient clinics of the Department of Family Medicine, National Taiwan University Hospital. A total of 42 clinics with over 15 patients will be randomized into two groups. The intervention group will adopt a FOR-Care model, required to measure and record blood pressure, height, and weight before consultations; while the control group receives usual care. The protected medical information will be accessed through the National Taiwan University Hospital Integrative Medical Database (NTUH-iMD). The quality improvement outcome is documentation of on-site blood pressure, height, and weight recordings of both groups at 12 and 24 weeks (cluster-level parameter). The primary preventive medicine outcome is newly diagnosed hypertension and diabetes mellitus (individual-level parameter). The secondary preventive medicine outcomes are clinical indicators of hypertension and diabetes mellitus in those with these diagnoses (individual-level parameters).

Expected Outcomes: The results of this pragmatic CRT will shed new insight into preventive medicine and quality of care in the management of common chronic diseases.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cluster-level inclusion criteria:

  • clinic sessions with at least 15 patients, but fewer than 40 patients

Cluster-level exclusion criteria:

  • travel, hospice, vaccination, or health examination clinics
  • special-appointed clinics

Patient-level exclusion criteria

  • patients aged less than 18
  • patients with active catastrophic illness or terminal malignancies
  • patients with major adverse cardiac events within 3 months before the index dates

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

800 participants in 2 patient groups

No Intervention Group
No Intervention group
Description:
This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data.
Intervention Group
Experimental group
Description:
This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.
Treatment:
Diagnostic Test: Height, Weight, and Blood Pressure Measurement Procedures Improvement

Trial contacts and locations

1

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Central trial contact

Yen-Kai Chen, MD; Chien-Hsieh Chiang, MD, MPH, PhD

Data sourced from clinicaltrials.gov

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