HypertensionCHARMEDNCT06113458
Comparing Hypertension Remote Monitoring Evaluation Redesign
A study testing Standard and One-time Training, Standard and Practice Facilitation and High-intensity and One-time Training in people with Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Standard and One-time Training, Standard and Practice Facilitation and High-intensity and One-time Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to Jul 2028
- 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
Who may be able to join
- 18 years or older
- Any sex/gender
- Any race or ethnicity
- Have hypertension or high blood pressure (BP) (BP >=140/90 mmHg at least twice in the previous 18 months)
- Can read and write English or Spanish
- Be able to provide consent
Who cannot join
- We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported:
- Pregnancy
- Lactating/nursing
- Dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).
- Conditions
- Hypertension
- Being tested
- Standard and One-time Training, Standard and Practice Facilitation, High-intensity and One-time Training, High-intensity and Practice Facilitation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard and One-time TrainingBehavioural
Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring.
Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.
Standard and Practice FacilitationBehavioural
Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring.
Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.
High-intensity and One-time TrainingBehavioural
Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring.
Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.
High-intensity and Practice FacilitationBehavioural
Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring.
Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.
| Study group | Role | What they receive |
|---|---|---|
| Standard and One-time Training | Active comparator | Patient level: Standard, automatic reminders Clinic level: One-time training Receives: Behavioral: Standard and One-time Training |
| Standard and Practice Facilitation | Experimental | Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching Receives: Behavioral: Standard and Practice Facilitation |
| High-intensity and One-time Training | Experimental | Patient level: Personalized feedback Clinic level: One-time training Receives: Behavioral: High-intensity and One-time Training |
| High-intensity and Practice Facilitation | Experimental | Patient level: Personalized feedback Clinic level: Regular, ongoing coaching Receives: Behavioral: High-intensity and Practice Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic BP (clinic)
Clinic-based BP readings in EHR
Measured: Baseline, 6 months
Secondary outcomes (5)
Change in systolic BP (home)
Home-based BP readings
Measured: Baseline, 6 months
Patient activation and satisfaction
Patients will complete the Patient Assessment of Chronic Illness Care (PACIC) survey of 20 questions regarding elements of the care of their chronic condition(s) over the last six months. Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "Almost Never" and 5 signifying "Almost Always".
Measured: Baseline, 6 months
Number of participants with BP control
<140/90mmHg, at the patient level within the EHR
Measured: Baseline, 6 months
Medication intensification when BP is uncontrolled
Number of classes of anti-hypertensive medications prescribed per patient
Measured: Baseline, 6 months
Patient-reported medication adherence
Patients will complete the 4-item Krousel-Wood Medication Adherence Scale (M-Wood-MAS-4). The scale score is calculated by summing the points for the 4 questions (scale score ranges from 0 to 4, with higher score indicating worse adherence); low adherence on the K-Wood-MAS-4 is defined as a score ≥1.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start21 Oct 2024
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Urmimala Sarkar, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113458
- Sponsor's protocol ID
- P0564385
- Acronym
- CHARMED
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tieu L, Khoong EC, Shah ND, Gosdin MM, Wang SJ, Sharma A, Abtahi N, Stern RJ, Zhou C, Sarkar U, Lyles CR; CHARMED Consortium. Applying behavior change theory to intervention design: promoting clinic-level implementation of self-measured blood pressure monitoring in safety net primary care settings. Transl Behav Med. 2026 Jan 7;16(1):ibaf094. doi: 10.1093/tbm/ibaf094.
PubMed 41723583Lyles CR, Khoong EC, Stern RJ, Abtahi N, Sharma AE, Pletcher MJ, Xia F, Garcia F, Shah ND, Tieu L, Sarkar U; CHARMED consortium. Championing Hypertension Remote Monitoring for Equity and Dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol. Contemp Clin Trials. 2025 May;152:107879. doi: 10.1016/j.cct.2025.107879. Epub 2025 Mar 12.
PubMed 40086748
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Hypertension Remote Monitoring Evaluation Redesign
- ClinicalTrials.gov ID
- NCT06113458
- Acronym / sponsor ID
- CHARMED / P0564385
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 Nov 2023 (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.
The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard and One-time Training | Active comparator | Behavioral: Standard and One-time TrainingPatient level: Standard, automatic reminders Clinic level: One-time training |
| Standard and Practice Facilitation | Experimental | Behavioral: Standard and Practice FacilitationPatient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching |
| High-intensity and One-time Training | Experimental | Behavioral: High-intensity and One-time TrainingPatient level: Personalized feedback Clinic level: One-time training |
| High-intensity and Practice Facilitation | Experimental | Behavioral: High-intensity and Practice FacilitationPatient level: Personalized feedback Clinic level: Regular, ongoing coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Any sex/gender
- Any race or ethnicity
- Have hypertension or high blood pressure (BP) (BP >=140/90 mmHg at least twice in the previous 18 months)
- Can read and write English or Spanish
Key exclusion criteria (4 listed)
- We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported:
- Pregnancy
- Lactating/nursing
- Dialysis
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 |
|---|---|---|
| Standard and One-time TrainingPatient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach. | Behavioural | Standard and One-time Training |
| Standard and Practice FacilitationPatient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach. | Behavioural | Standard and Practice Facilitation |
| High-intensity and One-time TrainingPatient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach. | Behavioural | High-intensity and One-time Training |
| High-intensity and Practice FacilitationPatient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach. | Behavioural | High-intensity and Practice Facilitation |
Primary outcome
Change in systolic BP (clinic)
Time frame: Baseline, 6 months
Clinic-based BP readings in EHR
5 secondary outcomes
Change in systolic BP (home)
Time frame: Baseline, 6 months
Patient activation and satisfaction
Time frame: Baseline, 6 months
Number of participants with BP control
Time frame: Baseline, 6 months
Medication intensification when BP is uncontrolled
Time frame: Baseline, 6 months
Patient-reported medication adherence
Time frame: Baseline, 6 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 15 Oct 2026.
- Derived from this study: PubMed 41723583Tieu L, Khoong EC, Shah ND, Gosdin MM, Wang SJ, Sharma A, Abtahi N, Stern RJ, Zhou C, Sarkar U, Lyles CR; CHARMED Consortium. Applying behavior change theory to intervention design: promoting clinic-level implementation of self-measured blood pressure monitoring in safety net primary care settings. Transl Behav Med. 2026 Jan 7;16(1):ibaf094. doi: 10.1093/tbm/ibaf094.
- Derived from this study: PubMed 40086748Lyles CR, Khoong EC, Stern RJ, Abtahi N, Sharma AE, Pletcher MJ, Xia F, Garcia F, Shah ND, Tieu L, Sarkar U; CHARMED consortium. Championing Hypertension Remote Monitoring for Equity and Dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol. Contemp Clin Trials. 2025 May;152:107879. doi: 10.1016/j.cct.2025.107879. Epub 2025 Mar 12.
- Individual participant dataSharing planned: No
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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.
Urmimala Sarkar principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard and One-time Training, Standard and Practice Facilitation and High-intensity and One-time Training in people with Hypertension, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. 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 15 Oct 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 United States. 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?
Change in systolic BP (clinic) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113458, which also lists 2 linked publications.
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 15 Oct 2026.