HypertensionNCT02996565
Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
A study testing Best Practice Clinic-Based Care and Telehealth Care in people with Hypertension, run by HealthPartners Institute at 1 site in United States.
Trial summary
This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Best Practice Clinic-Based Care and Telehealth Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,071 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypertension diagnosis code in medical record, twice in last 24 months
- Attends study clinic for primary care visit within study period with uncontrolled blood pressure
- Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at current visit
- Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at most recent previous visit
Who cannot join
- Pregnancy
- End Stage Kidney Disease
- Patients in hospice care and patients who permanently reside in a nursing home
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Institute
Bloomington, Minnesota, 55425
About this study
This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension.
The investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.
Read the detailed description
The objectives of the study are:
Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and other outcomes important to patients: best-practice clinic-based care and home-based telehealth care.
- Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in systolic blood pressure over 12 months of follow-up.
- Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will report: a) fewer treatment side effects; b) better ratings of patient experience of hypertension care; and c) higher self-monitoring rates and confidence in self-care.
Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods approach supported by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).
- Conditions
- Hypertension
- Being tested
- Best Practice Clinic-Based Care, Telehealth Care
- Keywords
- Clinic care, Team-based care, Medication Therapy Management (MTM), Telehealth, Cluster-randomized, Home blood pressure monitoring, Pharmacist
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice Clinic-Based CareOther
Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote:
- Improved recognition of uncontrolled BP at primary care encounters,
- Therapeutic action to address uncontrolled BP at primary care encounters,
- Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.
Telehealth CareOther
All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically:
- Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device
- Systematic home BP telemonitoring with data transmitted into patient medical record
- Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email
| Study group | Role | What they receive |
|---|---|---|
| Best Practice Clinic-Based Care | Active comparator | Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention. Receives: Other: Best Practice Clinic-Based Care |
| Telehealth Care | Active comparator | Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention. Receives: Other: Telehealth Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)
Change in systolic BP, collected from medical records
Measured: Trajectory over 12 months
Secondary outcomes (29)
Change in Diastolic BP Between Baseline and 12 Months (mm Hg)
change in diastolic BP, collected from medical records
Measured: Trajectory over 12 months
Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up
Patient report of monitoring BP at least 2 times per week
Measured: Baseline to 6 months
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
Patient rating of 9-10 vs. 0-8 on a scale of 0 (low satisfaction) to 10 (high satisfaction). Developed from a scale used by Green, et al (2008).
Citation: Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D,Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008;299:2857-2867. doi:10.1001/jama.299.24.2857
Measured: Baseline to 6 months
Number of Participants Who Are Current Smokers at Twelve Months
Current smoker at 12 months
Measured: Baseline to 12 months
Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months
Patient report that side effect is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Measured: Baseline to 6 months
Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self-management
Measured: Baseline to 6 months
Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self-management
Measured: Baseline to 6 months
Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self management
Measured: Baseline to 6 months
Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self management
Measured: Baseline to 6 months
Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self management
Measured: Baseline to 6 months
Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Measuring BP as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Phone Visits as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months
Patient report that burden is a problem
Measured: Baseline to 6 months
Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team
Patient reported "very" or "extremely" confident in this aspect of BP management.
Measured: Baseline to 6 months
Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management.
Measured: Baseline to 6 months
Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management
Measured: Baseline to 6 months
Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management
Measured: Baseline to 6 months
Number of Participants Reporting High Confidence in Taking BP Medications at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management
Measured: Baseline to 6 months
Number of Participants With Statin Addition at 12 Months
New statin medication current at 12 months
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start15 Nov 2017
- Primary completion17 Apr 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Karen Margolis, MD, Principal investigator, HealthPartners Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996565
- Sponsor's protocol ID
- HealthPartners Institute
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2016
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide a de-identified, individual-level dataset to PCORI if requested at the end of the study. The dataset will be made publicly available and will contain no identifying information.
Publications
Margolis KL, Crain AL, Pawloski PA, Ziegenfuss JY, Trower NK, Bergdall AR, Beran M, Norton CK, Haugen PK, Rehrauer DJ, Green BB, Solberg LI, Sperl-Hillen JM. Blood Pressure Medication Side Effect Symptoms and Patient Treatment Satisfaction and Adherence. J Am Board Fam Med. 2025 Mar-Apr;38(2):312-329. doi: 10.3122/jabfm.2024.240288R1.
PubMed 40578923Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25.
PubMed 36281763JaKa M, Bergdall A, Beran MS, Solberg L, Green BB, Andersen J, Kodet A, Norman S, Haugen P, Crain L, Trower N, Sharma R, Rehrauer D, Maeztu C, Margolis K. Reach in a pragmatic hypertension trial: A critical RE-AIM component. Contemp Clin Trials. 2022 Oct;121:106896. doi: 10.1016/j.cct.2022.106896. Epub 2022 Aug 24.
PubMed 36029952Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3.
PubMed 35978336Solberg LI, Crain AL, Green BB, Ziegenfuss JY, Beran MS, Sperl-Hillen JM, Norton CK, Margolis KL. Experiences and Perceptions of Patients with Uncontrolled Hypertension Who are Dissatisfied with Their Hypertension Care. J Am Board Fam Med. 2021 Nov-Dec;34(6):1115-1122. doi: 10.3122/jabfm.2021.06.210240.
PubMed 34772767Margolis KL, Crain AL, Bergdall AR, Beran M, Anderson JP, Solberg LI, O'Connor PJ, Sperl-Hillen JM, Pawloski PA, Ziegenfuss JY, Rehrauer D, Norton C, Haugen P, Green BB, McKinney Z, Kodet A, Appana D, Sharma R, Trower NK, Williams R, Crabtree BF. Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure. Contemp Clin Trials. 2020 May;92:105939. doi: 10.1016/j.cct.2020.105939. Epub 2020 Jan 22.
PubMed 31981712
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
- ClinicalTrials.gov ID
- NCT02996565
- Acronym / sponsor ID
- HealthPartners Institute
- Conditions
- Hypertension
- Keywords
- Clinic care, Team-based care, Medication Therapy Management (MTM), Telehealth, Cluster-randomized, Home blood pressure monitoring, Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,071 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension.
The investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.
Detailed description
The objectives of the study are:
Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and other outcomes important to patients: best-practice clinic-based care and home-based telehealth care.
- Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in systolic blood pressure over 12 months of follow-up.
- Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will report: a) fewer treatment side effects; b) better ratings of patient experience of hypertension care; and c) higher self-monitoring rates and confidence in self-care.
Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods approach supported by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Practice Clinic-Based Care | Active comparator | Other: Best Practice Clinic-Based CarePatients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention. |
| Telehealth Care | Active comparator | Other: Telehealth CarePatients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertension diagnosis code in medical record, twice in last 24 months
- Attends study clinic for primary care visit within study period with uncontrolled blood pressure
- Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at current visit
- Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at most recent previous visit
Key exclusion criteria (3 listed)
- Pregnancy
- End Stage Kidney Disease
- Patients in hospice care and patients who permanently reside in a nursing home
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 |
|---|---|---|
| Best Practice Clinic-Based CareRelies primarily on the physician-medical assistant dyad and face-to-face visits to promote: 1. Improved recognition of uncontrolled BP at primary care encounters, 2. Therapeutic action to address uncontrolled BP at primary care encounters, 3. Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks. | Other | Best Practice Clinic-Based Care |
| Telehealth CareAll elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically: 1. Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device 2. Systematic home BP telemonitoring with data transmitted into patient medical record 3. Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email | Other | Telehealth Care |
Primary outcome
Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)
Time frame: Trajectory over 12 months
Change in systolic BP, collected from medical records
29 secondary outcomes
Change in Diastolic BP Between Baseline and 12 Months (mm Hg)
Time frame: Trajectory over 12 months
Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up
Time frame: Baseline to 6 months
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
Time frame: Baseline to 6 months
Number of Participants Who Are Current Smokers at Twelve Months
Time frame: Baseline to 12 months
Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months
Time frame: Baseline to 6 months
Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months
Time frame: Baseline to 6 months
Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months
Time frame: Baseline to 6 months
Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months
Time frame: Baseline to 6 months
Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months
Time frame: Baseline to 6 months
Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months
Time frame: Baseline to 6 months
Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Measuring BP as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Phone Visits as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Taking BP Medications at Six Months
Time frame: Baseline to 6 months
Number of Participants With Statin Addition at 12 Months
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40578923Margolis KL, Crain AL, Pawloski PA, Ziegenfuss JY, Trower NK, Bergdall AR, Beran M, Norton CK, Haugen PK, Rehrauer DJ, Green BB, Solberg LI, Sperl-Hillen JM. Blood Pressure Medication Side Effect Symptoms and Patient Treatment Satisfaction and Adherence. J Am Board Fam Med. 2025 Mar-Apr;38(2):312-329. doi: 10.3122/jabfm.2024.240288R1.
- Derived from this study: PubMed 36281763Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25.
- Derived from this study: PubMed 36029952JaKa M, Bergdall A, Beran MS, Solberg L, Green BB, Andersen J, Kodet A, Norman S, Haugen P, Crain L, Trower N, Sharma R, Rehrauer D, Maeztu C, Margolis K. Reach in a pragmatic hypertension trial: A critical RE-AIM component. Contemp Clin Trials. 2022 Oct;121:106896. doi: 10.1016/j.cct.2022.106896. Epub 2022 Aug 24.
- Derived from this study: PubMed 35978336Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3.
- Derived from this study: PubMed 34772767Solberg LI, Crain AL, Green BB, Ziegenfuss JY, Beran MS, Sperl-Hillen JM, Norton CK, Margolis KL. Experiences and Perceptions of Patients with Uncontrolled Hypertension Who are Dissatisfied with Their Hypertension Care. J Am Board Fam Med. 2021 Nov-Dec;34(6):1115-1122. doi: 10.3122/jabfm.2021.06.210240.
- Derived from this study: PubMed 31981712Margolis KL, Crain AL, Bergdall AR, Beran M, Anderson JP, Solberg LI, O'Connor PJ, Sperl-Hillen JM, Pawloski PA, Ziegenfuss JY, Rehrauer D, Norton C, Haugen P, Green BB, McKinney Z, Kodet A, Appana D, Sharma R, Trower NK, Williams R, Crabtree BF. Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure. Contemp Clin Trials. 2020 May;92:105939. doi: 10.1016/j.cct.2020.105939. Epub 2020 Jan 22.
- Individual participant dataSharing planned: Yes. We will provide a de-identified, individual-level dataset to PCORI if requested at the end of the study. The dataset will be made publicly available and will contain no identifying information.
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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.
Karen Margolis, MD principal investigator
HealthPartners Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Clinic-Based Care and Telehealth Care in people with Hypertension, run by HealthPartners Institute 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 23 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Blood Pressure Between Baseline and 12 Months (mm Hg) (time frame: Trajectory over 12 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 NCT02996565, which also lists 6 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 23 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.