Trial · NCT02996565
Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
NCT02996565, Not applicable, Completed, HealthPartners Institute; results first posted 2024-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure. Trials, record NCT02996565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02996565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
- NCT number
- NCT02996565
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,071 participants, actual
- Lead sponsor
- HealthPartners Institute
- Conditions
- Hypertension
- Interventions
- Best Practice Clinic-Based Care, Telehealth Care
- First posted
- 2016-12-19
- Last updated
- 2024-09-23
- Results first posted
- 2024-09-23
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg) | Trajectory over 12 months | Change in systolic BP, collected from medical records |
| Secondary | Change in Diastolic BP Between Baseline and 12 Months (mm Hg) | Trajectory over 12 months | change in diastolic BP, collected from medical records |
| Secondary | Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up | Baseline to 6 months | Patient report of monitoring BP at least 2 times per week |
| Secondary | Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months. | Baseline to 6 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 |
| Secondary | Number of Participants Who Are Current Smokers at Twelve Months | Baseline to 12 months | Current smoker at 12 months |
| Secondary | Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months | Baseline to 6 months | Patient report that side effect is a problem |
| Secondary | Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | Patient report that side effect is a problem |
| Secondary | Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | Patient report that side effect is a problem |
| Secondary | Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | Patient report that side effect is a problem |
| Secondary | Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | Patient report that side effect is a problem |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg) | Trajectory over 12 months | mm Hg | MEAN | |
| SECONDARY | Change in Diastolic BP Between Baseline and 12 Months (mm Hg) | Trajectory over 12 months | mm Hg | MEAN | |
| SECONDARY | Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months. | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Are Current Smokers at Twelve Months | Baseline to 12 months | The numbers of participants analyzed represent the number of participants with smoking status available in the EHR | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months | Baseline to 6 months | The numbers of participants analyzed represent the number of survey respondents who answered the specific survey item. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg) | Best Practice Clinic-Based Care | -17.97 | 95% Confidence Interval -19.43 to -16.50 | mm Hg | |
| Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg) | Telehealth Care | -18.72 | 95% Confidence Interval -20.20 to -17.24 | mm Hg | |
| Change in Diastolic BP Between Baseline and 12 Months (mm Hg) | Best Practice Clinic-Based Care | -9.98 | 95% Confidence Interval -10.84 to -9.11 | mm Hg | |
| Change in Diastolic BP Between Baseline and 12 Months (mm Hg) | Telehealth Care | -9.70 | 95% Confidence Interval -10.58 to -8.83 | mm Hg | |
| Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up | Best Practice Clinic-Based Care | 189 | Participants | ||
| Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up | Telehealth Care | 265 | Participants | ||
| Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months. | Best Practice Clinic-Based Care | 205 | Participants | ||
| Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months. | Telehealth Care | 241 | Participants | ||
| Number of Participants Who Are Current Smokers at Twelve Months | Best Practice Clinic-Based Care | 273 | Participants | ||
| Number of Participants Who Are Current Smokers at Twelve Months | Telehealth Care | 199 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Best Practice Clinic-Based Care | 1,648 | 9 |
| Overall Study | STARTED | Telehealth Care | 1,423 | 10 |
| Overall Study | Referred to Intended Provider for Hypertension Follow-up | Best Practice Clinic-Based Care | 1,480 | 9 |
| Overall Study | Referred to Intended Provider for Hypertension Follow-up | Telehealth Care | 1,060 | 10 |
| Overall Study | Attended Follow-up Within 6 Weeks (With Any Provider Type) | Best Practice Clinic-Based Care | 890 | 9 |
| Overall Study | Attended Follow-up Within 6 Weeks (With Any Provider Type) | Telehealth Care | 887 | 10 |
| Overall Study | Attended Follow-up Within 6 Weeks (With Intended Provider) | Best Practice Clinic-Based Care | 532 | 9 |
| Overall Study | Attended Follow-up Within 6 Weeks (With Intended Provider) | Telehealth Care | 385 | 10 |
| Overall Study | COMPLETED | Best Practice Clinic-Based Care | 532 | 9 |
| Overall Study | COMPLETED | Telehealth Care | 275 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hypotension | Vascular disorders | Best Practice Clinic-Based Care | 119 | 1,574 | |
| other | hypotension | Vascular disorders | Telehealth Care | 118 | 1,360 | |
| other | hypokalemia | Metabolism and nutrition disorders | Best Practice Clinic-Based Care | 194 | 1,510 | |
| other | hypokalemia | Metabolism and nutrition disorders | Telehealth Care | 187 | 1,294 | |
| other | hyperkalemia | Metabolism and nutrition disorders | Best Practice Clinic-Based Care | 87 | 1,588 | |
| other | hyperkalemia | Metabolism and nutrition disorders | Telehealth Care | 105 | 1,363 | |
| other | hyponatremia | Metabolism and nutrition disorders | Best Practice Clinic-Based Care | 172 | 1,535 | |
| other | hyponatremia | Metabolism and nutrition disorders | Telehealth Care | 190 | 1,262 | |
| other | abnormal eGFR | Renal and urinary disorders | Best Practice Clinic-Based Care | 227 | 1,380 | |
| other | abnormal eGFR | Renal and urinary disorders | Telehealth Care | 219 | 1,122 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Best Practice Clinic-Based Care | 42 | 1,648 |
| Total, all-cause mortality | Telehealth Care | 43 | 1,423 |
| Total, other adverse events | Best Practice Clinic-Based Care | 597 | 1,648 |
| Total, other adverse events | Telehealth Care | 567 | 1,422 |
| Total, serious adverse events | Best Practice Clinic-Based Care | 29 | 1,646 |
| Total, serious adverse events | Telehealth Care | 34 | 1,422 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons30
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants With Statin Addition at 12 Months | Trial comparisons |
| Best Practice Clinic-Based Care vs Telehealth Care: Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months | Trial comparisons |
1 to 10 of 30
See all 30 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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