Effects of FOR-Care Model on Preventive Medicine

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Body Weight; Family Medicine; Preventive Medicine; Hypertension
• Interventions: Diagnostic Test: Height, Weight, and Blood Pressure Measurement Procedures Improvement

• Registration Number: NCT06406192
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-04-28
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-10-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Height, Weight, and Blood Pressure Measurement Procedures Improvement	This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.

Primary Outcome Measures

Name	Time	Method
Rate of Newly-Diagnosed Diabetes Mellitus	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of diabetes mellitus.
Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	The documentation of on-site blood pressure, height, and weight recordings
Rate of Newly-Diagnosed Hypertension	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of hypertension.

Secondary Outcome Measures

Name	Time	Method
Urinary Microalbumin Excretion	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	Assessing whether the intervention affects renal function (all patients)
Home Blood Pressure in Hypertensionsive Patients	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	Assessing whether the intervention affects clinical indicators of hypertension
Estimated Glomerular Filtration Rate	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	Assessing whether the intervention affects renal function (all patients)
Office Blood Pressure in Hypertensionsive Patients	From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward	Assessing whether the intervention affects clinical indicators of hypertension
Mortality Rate	From date of randomization until the date of first documented progression, assessed up to 36 months	Assessing whether the intervention affects longterm survival status

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan