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Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure

Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02996565
Enrollment
3071
Registered
2016-12-19
Start date
2017-11-15
Completion date
2021-06-30
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Clinic care, Team-based care, Medication Therapy Management (MTM), Telehealth, Cluster-randomized, Home blood pressure monitoring, Pharmacist

Brief 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. 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).

Interventions

OTHERBest Practice Clinic-Based Care

Relies 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.

All 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

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Pregnancy * End Stage Kidney Disease * Patients in hospice care and patients who permanently reside in a nursing home

Design outcomes

Primary

MeasureTime frameDescription
Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)Trajectory over 12 monthsChange in systolic BP, collected from medical records

Secondary

MeasureTime frameDescription
Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-upBaseline to 6 monthsPatient report of monitoring BP at least 2 times per week
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.Baseline to 6 monthsPatient 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
Number of Participants Who Are Current Smokers at Twelve MonthsBaseline to 12 monthsCurrent smoker at 12 months
Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care TeamBaseline to 6 monthsPatient reported very or extremely confident in this aspect of BP management.
Number of Participants Reporting High Confidence in Keeping BP Below Target at Six MonthsBaseline to 6 monthsPatient reported very or extremely confident in this aspect of BP management.
Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six MonthsBaseline to 6 monthsPatient report that side effect is a problem
Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six MonthsBaseline to 6 monthsPatient report that side effect is a problem
Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six MonthsBaseline to 6 monthsPatient report that side effect is a problem
Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six MonthsBaseline to 6 monthsPatient report that side effect is a problem
Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six MonthsBaseline to 6 monthsPatient report that side effect is a problem
Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six MonthsBaseline to 6 monthsPatient report that side effect is a problem
Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six MonthsBaseline to 6 monthsPatient report that activity is helpful for BP self-management
Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six MonthsBaseline to 6 monthsPatient report that activity is helpful for BP self-management
Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six MonthsBaseline to 6 monthsPatient report that activity is helpful for BP self management
Change in Diastolic BP Between Baseline and 12 Months (mm Hg)Trajectory over 12 monthschange in diastolic BP, collected from medical records
Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six MonthsBaseline to 6 monthsPatient report that activity is helpful for BP self management
Number of Participants Identifying Clinic Visits as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting Measuring BP as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting Phone Visits as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting Scheduling Visits as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting Time Away From Work as BP Care Burden at Six MonthsBaseline to 6 monthsPatient report that burden is a problem
Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six MonthsBaseline to 6 monthsPatient reported very or extremely confident in this aspect of BP management
Number of Participants Reporting High Confidence in Measuring BP at Home at Six MonthsBaseline to 6 monthsPatient reported very or extremely confident in this aspect of BP management
Number of Participants Reporting High Confidence in Taking BP Medications at Six MonthsBaseline to 6 monthsPatient reported very or extremely confident in this aspect of BP management
Number of Participants With Statin Addition at 12 MonthsBaseline to 12 monthsNew statin medication current at 12 months
Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six MonthsBaseline to 6 monthsPatient report that activity is helpful for BP self management

Countries

United States

Participant flow

Recruitment details

Participants were screened and enrolled during primary care encounters at eligible and randomized primary care clinics in a large integrated health system. Patients were enrolled between November 15, 2017 and April 15, 2019.

Pre-assignment details

Among 57 primary care clinics screened for eligibility, 36 were excluded (16 no MTM; 20 not using automated BP monitor) and 21 were randomized (17 individual clinics plus 4 clinics as 2 co-located pairs). Among 69,480 patients screened in primary care encounters, 3,071 met all inclusion criteria and were enrolled in the study and received care according to the clinic-randomized treatment arm.

Participants by arm

ArmCount
Best Practice Clinic-Based Care
Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention. Best Practice Clinic-Based Care: Relies 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.
1,648
Telehealth Care
Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention. Telehealth Care: All 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
1,423
Total3,071

Baseline characteristics

CharacteristicBest Practice Clinic-Based CareTotalTelehealth Care
Age, Continuous58.3 years
STANDARD_DEVIATION 14.2
60.2 years
STANDARD_DEVIATION 14.4
62.4 years
STANDARD_DEVIATION 14.2
Annual Income
$20,000 to $49,999
258 Participants443 Participants185 Participants
Annual Income
$50,000 to $99,999
231 Participants469 Participants238 Participants
Annual Income
Greater than or equal to $100,000
145 Participants262 Participants117 Participants
Annual Income
Less than $20,000
164 Participants307 Participants143 Participants
Body Mass Index (BMI) greater than or equal to 30987 Participants1730 Participants743 Participants
Cardiovascular disease247 Participants512 Participants265 Participants
Diabetes407 Participants773 Participants366 Participants
Diastolic Blood Pressure (DBP)93.1 mm Hg
STANDARD_DEVIATION 13.8
91.7 mm Hg
STANDARD_DEVIATION 13.9
90.0 mm Hg
STANDARD_DEVIATION 13.8
Employment
Full-time
351 Participants582 Participants231 Participants
Employment
Otherwise not working for pay
154 Participants290 Participants136 Participants
Employment
Part-time
71 Participants139 Participants68 Participants
Employment
Retired
332 Participants682 Participants350 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
46 Participants60 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1585 Participants2971 Participants1386 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
17 Participants40 Participants23 Participants
Highest education level
>4-year college degree
106 Participants218 Participants112 Participants
Highest education level
4-year college degree
171 Participants308 Participants137 Participants
Highest education level
High school, GED, or less
316 Participants563 Participants247 Participants
Highest education level
Some college or technical school
315 Participants599 Participants284 Participants
Number of anti-hypertensive medication classes1.7 anti-hypertensive medication classes
STANDARD_DEVIATION 1.1
1.7 anti-hypertensive medication classes
STANDARD_DEVIATION 1.1
1.7 anti-hypertensive medication classes
STANDARD_DEVIATION 1.2
Race (NIH/OMB)
American Indian or Alaska Native
15 Participants19 Participants4 Participants
Race (NIH/OMB)
Asian
92 Participants213 Participants121 Participants
Race (NIH/OMB)
Black or African American
329 Participants594 Participants265 Participants
Race (NIH/OMB)
More than one race
8 Participants15 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
59 Participants95 Participants36 Participants
Race (NIH/OMB)
White
1144 Participants2132 Participants988 Participants
Sex: Female, Male
Female
834 Participants1639 Participants805 Participants
Sex: Female, Male
Male
814 Participants1432 Participants618 Participants
Systolic Blood Pressure (SBP)157.4 mm Hg
STANDARD_DEVIATION 15.4
158.0 mm Hg
STANDARD_DEVIATION 15.3
158.8 mm Hg
STANDARD_DEVIATION 15.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
42 / 1,64843 / 1,423
other
Total, other adverse events
597 / 1,648567 / 1,422
serious
Total, serious adverse events
29 / 1,64634 / 1,422

Outcome results

Primary

Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)

Change in systolic BP, collected from medical records

Time frame: Trajectory over 12 months

ArmMeasureValue (MEAN)
Best Practice Clinic-Based CareChange in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)-17.97 mm Hg
Telehealth CareChange in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)-18.72 mm Hg
p-value: 0.4595% CI: [-2.84, 1.33]planned contrast
Secondary

Change in Diastolic BP Between Baseline and 12 Months (mm Hg)

change in diastolic BP, collected from medical records

Time frame: Trajectory over 12 months

ArmMeasureValue (MEAN)
Best Practice Clinic-Based CareChange in Diastolic BP Between Baseline and 12 Months (mm Hg)-9.98 mm Hg
Telehealth CareChange in Diastolic BP Between Baseline and 12 Months (mm Hg)-9.70 mm Hg
p-value: 0.6495% CI: [-0.95, 1.51]planned contrast
Secondary

Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Identifying Clinic Visits as BP Care Burden at Six Months196 Participants
Telehealth CareNumber of Participants Identifying Clinic Visits as BP Care Burden at Six Months149 Participants
p-value: 0.0895% CI: [0.68, 1.03]Mixed Models Analysis
Secondary

Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months188 Participants
Telehealth CareNumber of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months134 Participants
p-value: 0.3295% CI: [0.73, 1.11]Mixed Models Analysis
Secondary

Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months

Patient report that side effect is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months202 Participants
Telehealth CareNumber of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months212 Participants
p-value: 0.0895% CI: [0.98, 1.4]Mixed Models Analysis
Secondary

Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months

Patient report that side effect is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months247 Participants
Telehealth CareNumber of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months232 Participants
p-value: 0.1895% CI: [0.95, 1.29]Mixed Models Analysis
Secondary

Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months

Patient report that side effect is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months331 Participants
Telehealth CareNumber of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months293 Participants
p-value: 0.7795% CI: [0.87, 1.11]Mixed Models Analysis
Secondary

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.

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting High Confidence in Keeping BP Below Target at Six Months242 Participants
Telehealth CareNumber of Participants Reporting High Confidence in Keeping BP Below Target at Six Months252 Participants
p-value: 0.8395% CI: [0.83, 1.25]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months437 Participants
Telehealth CareNumber of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months465 Participants
p-value: 0.4195% CI: [0.95, 1.13]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting High Confidence in Measuring BP at Home at Six Months376 Participants
Telehealth CareNumber of Participants Reporting High Confidence in Measuring BP at Home at Six Months412 Participants
p-value: 0.495% CI: [0.94, 1.16]Mixed Models Analysis
Secondary

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.

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team481 Participants
Telehealth CareNumber of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team467 Participants
p-value: 0.6595% CI: [0.94, 1.1]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting High Confidence in Taking BP Medications at Six Months564 Participants
Telehealth CareNumber of Participants Reporting High Confidence in Taking BP Medications at Six Months532 Participants
p-value: 0.7495% CI: [0.95, 1.07]Mixed Models Analysis
Secondary

Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months236 Participants
Telehealth CareNumber of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months242 Participants
p-value: 0.0995% CI: [0.98, 1.33]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months247 Participants
Telehealth CareNumber of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months208 Participants
p-value: 0.3295% CI: [0.8, 1.08]Mixed Models Analysis
Secondary

Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months251 Participants
Telehealth CareNumber of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months192 Participants
p-value: 0.7795% CI: [0.83, 1.16]Mixed Models Analysis
Secondary

Number of Participants Reporting Measuring BP as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Measuring BP as BP Care Burden at Six Months158 Participants
Telehealth CareNumber of Participants Reporting Measuring BP as BP Care Burden at Six Months164 Participants
p-value: 0.0995% CI: [0.97, 1.5]Mixed Models Analysis
Secondary

Number of Participants Reporting Phone Visits as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Phone Visits as BP Care Burden at Six Months94 Participants
Telehealth CareNumber of Participants Reporting Phone Visits as BP Care Burden at Six Months66 Participants
p-value: 0.0295% CI: [0.45, 0.92]Mixed Models Analysis
Secondary

Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Scheduling Visits as BP Care Burden at Six Months186 Participants
Telehealth CareNumber of Participants Reporting Scheduling Visits as BP Care Burden at Six Months127 Participants
p-value: 0.00695% CI: [0.55, 0.89]Mixed Models Analysis
Secondary

Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months

Patient report that side effect is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months174 Participants
Telehealth CareNumber of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months132 Participants
p-value: 0.6295% CI: [0.76, 1.19]Mixed Models Analysis
Secondary

Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months

Patient report that burden is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Time Away From Work as BP Care Burden at Six Months159 Participants
Telehealth CareNumber of Participants Reporting Time Away From Work as BP Care Burden at Six Months92 Participants
p-value: 0.0695% CI: [0.6, 1.01]Mixed Models Analysis
Secondary

Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months

Patient report that side effect is a problem

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months437 Participants
Telehealth CareNumber of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months376 Participants
p-value: 0.8795% CI: [0.91, 1.08]Mixed Models Analysis
Secondary

Number of Participants Who Are Current Smokers at Twelve Months

Current smoker at 12 months

Time frame: Baseline to 12 months

Population: The numbers of participants analyzed represent the number of participants with smoking status available in the EHR

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Are Current Smokers at Twelve Months273 Participants
Telehealth CareNumber of Participants Who Are Current Smokers at Twelve Months199 Participants
p-value: 0.7395% CI: [0.95, 1.07]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months274 Participants
Telehealth CareNumber of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months242 Participants
p-value: 0.5195% CI: [0.82, 1.11]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.205 Participants
Telehealth CareNumber of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.241 Participants
p-value: 0.0395% CI: [1.02, 1.52]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up189 Participants
Telehealth CareNumber of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up265 Participants
p-value: <0.00195% CI: [1.27, 1.85]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months147 Participants
Telehealth CareNumber of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months138 Participants
p-value: 0.4195% CI: [0.87, 1.37]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months291 Participants
Telehealth CareNumber of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months256 Participants
p-value: 0.1895% CI: [0.77, 1.06]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months278 Participants
Telehealth CareNumber of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months243 Participants
p-value: 0.3195% CI: [0.78, 1.09]Mixed Models Analysis
Secondary

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

Time frame: Baseline to 6 months

Population: The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months290 Participants
Telehealth CareNumber of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months249 Participants
p-value: 0.5695% CI: [0.89, 1.22]Mixed Models Analysis
Secondary

Number of Participants With Statin Addition at 12 Months

New statin medication current at 12 months

Time frame: Baseline to 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Clinic-Based CareNumber of Participants With Statin Addition at 12 Months162 Participants
Telehealth CareNumber of Participants With Statin Addition at 12 Months151 Participants
p-value: 0.7195% CI: [0.81, 1.37]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026