Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06406192

Effects of FOR-Care Model on Preventive Medicine

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus Body Weight Cardiovascular Diseases Endocrine System Diseases Family Medicine Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Preventive Medicine Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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?"

Other names: FOR-Care Model

Primary outcomes

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

    Time frame: 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

  2. Rate of Newly-Diagnosed Hypertension

    Time frame: 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.

  3. Rate of Newly-Diagnosed Diabetes Mellitus

    Time frame: 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.

Secondary outcomes

  1. Office Blood Pressure in Hypertensionsive Patients

    Time frame: 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

  2. Home Blood Pressure in Hypertensionsive Patients

    Time frame: 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

  3. Estimated Glomerular Filtration Rate

    Time frame: 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)

  4. Urinary Microalbumin Excretion

    Time frame: 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)

  5. Mortality Rate

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

    Assessing whether the intervention affects longterm survival status

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
May 9, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.