Diabetes MellitusNCT06406192
Effects of FOR-Care Model on Preventive Medicine
A study testing Height, Weight, and Blood Pressure Measurement Procedures Improvement in people with Diabetes Mellitus and Body Weight, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Body Weight, Family Medicine
- What is being tested?
- Height, Weight, and Blood Pressure Measurement Procedures Improvement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial
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.
Read the 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.
- Being tested
- Height, Weight, and Blood Pressure Measurement Procedures Improvement
- Keywords
- Body weight, Diabetes mellitus, Cluster randomized trial, Family medicine, Outpatient department, Preventive medicine
- Medical subject headings
- Diabetes Mellitus, Body Weight, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Height, Weight, and Blood Pressure Measurement Procedures ImprovementDiagnostic test
Also called FOR-Care Model
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:
- 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.
- 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?"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Height, Weight, and Blood Pressure Measurement Procedures Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings
The documentation of on-site blood pressure, height, and weight recordings
Measured: 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.
Measured: 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.
Measured: 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
Assessing whether the intervention affects clinical indicators of hypertension
Measured: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Home Blood Pressure in Hypertensionsive Patients
Assessing whether the intervention affects clinical indicators of hypertension
Measured: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Estimated Glomerular Filtration Rate
Assessing whether the intervention affects renal function (all patients)
Measured: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Urinary Microalbumin Excretion
Assessing whether the intervention affects renal function (all patients)
Measured: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Mortality Rate
Assessing whether the intervention affects longterm survival status
Measured: From date of randomization until the date of first documented progression, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start11 Mar 2024
- Primary completion30 Oct 2024
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Hsieh Chiang, MD, MPH, PhD, Study chair, Family MedicineClinical Assistant Professor, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406192
- Sponsor's protocol ID
- 202402048RIND
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06406192
- Acronym / sponsor ID
- 202402048RIND
- Keywords
- Body weight, Diabetes mellitus, Cluster randomized trial, Family medicine, Outpatient department, Preventive medicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Height, Weight, and Blood Pressure Measurement Procedures ImprovementThis group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Height, Weight, and Blood Pressure Measurement Procedures ImprovementAlso: FOR-Care ModelIn 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?" | Diagnostic test | Intervention Group |
Primary outcome
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
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.
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.
5 secondary outcomes
Office Blood Pressure in Hypertensionsive Patients
Time frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Home Blood Pressure in Hypertensionsive Patients
Time frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Estimated Glomerular Filtration Rate
Time frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Urinary Microalbumin Excretion
Time frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Mortality Rate
Time frame: From date of randomization until the date of first documented progression, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hsieh Chiang, MD, MPH, PhD study chair
Family MedicineClinical Assistant Professor, Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Height, Weight, and Blood Pressure Measurement Procedures Improvement in people with Diabetes Mellitus and Body Weight, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.