Effects of FOR-Care Model on Preventive Medicine

NCT06406192 | Active Not Recruiting DMC

• 1 other identifier: 202402048RIND
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Body Weight; Family Medicine; Hypertension; Preventive Medicine

Keywords

Body weight; Diabetes mellitus; Cluster randomized trial; Family medicine; Outpatient department; Preventive medicine

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings

  The documentation of on-site blood pressure, height, and weight recordings

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

• Rate of Newly-Diagnosed Hypertension

  Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of hypertension.

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

• Rate of Newly-Diagnosed Diabetes Mellitus

  Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of diabetes mellitus.

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

Secondary Outcomes (5)

• Office Blood Pressure in Hypertensionsive Patients

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

• Home Blood Pressure in Hypertensionsive Patients

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

• Estimated Glomerular Filtration Rate

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

• Urinary Microalbumin Excretion

  From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward

• Mortality Rate

  From date of randomization until the date of first documented progression, assessed up to 36 months

Study Arms (2)

No Intervention Group

NO INTERVENTION

This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data.

Intervention Group

EXPERIMENTAL

This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.

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

Interventions

Height, Weight, and Blood Pressure Measurement Procedures Improvement DIAGNOSTIC_TEST

In the intervention group, the investigators improve the process of measuring blood pressure, height, and weight, requiring timely recording of these measurements. The intervention includes: i. Enlisting the assistance of nurses and volunteers to improve the accessibility of measurement environments and provide guidance on instrument operation. ii. Using paper reminders at check-in stations to prompt patients to complete blood pressure and weight recordings before entering examination rooms; providing paper for recording if patients forget their health insurance cards. iii. Providing alcohol and hand wipes outside examination rooms for disinfecting measurement instruments. iv. Promoting the recording mode outside the check-in station. v. Ensuring that physicians or nurses in examination rooms accurately record measurements in the medical order system. vi. Encouraging patients to ask physicians during consultations, "Is my blood pressure and weight okay?"

Also known as: FOR-Care Model

Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Body Weight; Hypertension

Interventions

Body Height

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development

Study Officials

• Chien-Hsieh Chiang, MD, MPH, PhD

  Family MedicineClinical Assistant Professor, Department of Family Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 9, 2024
• Study Start: March 11, 2024
• Primary Completion: October 30, 2024
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)