Trial · NCT03461003
N-of-1 Trials In Children With Hypertension
NCT03461003, Phase 4, Completed, The University of Texas Health Science Center, Houston; results first posted 2022-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. N-of-1 Trials In Children With Hypertension. Trials, record NCT03461003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03461003
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- N-of-1 Trials In Children With Hypertension
- NCT number
- NCT03461003
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 49 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Pediatric Hypertension
- Interventions
- NICHE method, Usual care, Amlodipine, Lisinopril, Hydrochlorothiazide, Losartan
- First posted
- 2018-03-09
- Last updated
- 2022-09-09
- Results first posted
- 2022-09-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months | 6 months from enrollment | Blood pressure control is when ambulatory blood pressure is normal, with normal as defined by the American Heart Association (AHA) criteria \[the AHA criteria are systolic blood pressure and diastolic blood pressure (throughout wake and sleep) less than the 95th percentile based on the patient's gender and height\]. To assess ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period. |
| Secondary | Change in Mean 24-hour Ambulatory Systolic Blood Pressure | baseline, 6 months | To assess 24-hour mean ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period, while awake and while asleep. The mean of all recordings over the 24-hour period is calculated per participant for both baseline and 6 months, and then the mean 24-hour systolic blood pressure at 6 months minus the mean 24-hour systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time. |
| Secondary | Change in Mean Wake Ambulatory Systolic Blood Pressure | baseline, 6 months | To assess mean wake ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24 hour period, throughout wake and sleep. The mean of all recordings that occur while the participant is awake during the 24-hour period is calculated for both baseline and 6 months, and then the mean wake systolic blood pressure at 6 months minus the mean wake systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time. |
| Secondary | Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication | from baseline to 6 months | |
| Secondary | Number of Participants Who Self-reported Adherence to Intervention | from month 5 to month 6 | Adherence is reported as the number of participants who self-reported at the 6-month visit that they had not missed any doses of their medication in the preceding month. |
| Secondary | Patient Satisfaction With Intervention as Assessed by a Survey | 6 months | Patient satisfaction is scored from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months | 6 months from enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Mean 24-hour Ambulatory Systolic Blood Pressure | baseline, 6 months | One patient in each arm was missing a baseline ambulatory blood pressure monitoring (ABPM), so change from baseline could not be calculated for each of those participants | mmHg | MEAN |
| SECONDARY | Change in Mean Wake Ambulatory Systolic Blood Pressure | baseline, 6 months | One patient in each arm was missing a baseline ambulatory blood pressure monitoring (ABPM), so change from baseline could not be calculated for each of those participants | mmHg | MEAN |
| SECONDARY | Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication | from baseline to 6 months | Data were not collected from 5 participants in the NICHE method arm, and data were not collected from 5 participants in the Usual Care arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Self-reported Adherence to Intervention | from month 5 to month 6 | Data were not collected for 3 participants in the NICHE method arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Satisfaction With Intervention as Assessed by a Survey | 6 months | Data were not collected for 4 participants in the NICHE method arm. Data were not collected for 2 participants in the Usual Care arm. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months | NICHE Method | Controlled | 8 | Participants | |
| Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months | Usual Care | Controlled | 8 | Participants | |
| Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months | NICHE Method | Uncontrolled | 10 | Participants | |
| Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months | Usual Care | Uncontrolled | 15 | Participants | |
| Change in Mean 24-hour Ambulatory Systolic Blood Pressure | NICHE Method | -10.6 | Standard Deviation 9.301 | mmHg | |
| Change in Mean 24-hour Ambulatory Systolic Blood Pressure | Usual Care | -5.1 | Standard Deviation 9.586 | mmHg | |
| Change in Mean Wake Ambulatory Systolic Blood Pressure | NICHE Method | -10.5 | Standard Deviation 7.747 | mmHg | |
| Change in Mean Wake Ambulatory Systolic Blood Pressure | Usual Care | -6.2 | Standard Deviation 10.123 | mmHg | |
| Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication | NICHE Method | 0 | Participants | ||
| Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication | Usual Care | 3 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NICHE Method | 23 | |
| Overall Study | STARTED | Usual Care | 26 | |
| Overall Study | Received Intervention | NICHE Method | 21 | |
| Overall Study | Received Intervention | Usual Care | 22 | |
| Overall Study | Completed 6-month Follow up | NICHE Method | 18 | |
| Overall Study | Completed 6-month Follow up | Usual Care | 23 | |
| Overall Study | COMPLETED | NICHE Method | 18 | |
| Overall Study | COMPLETED | Usual Care | 23 | |
| Overall Study | NOT COMPLETED | NICHE Method | 5 | |
| Overall Study | NOT COMPLETED | Usual Care | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Dizziness | Gastrointestinal disorders | NICHE Method | 0 | 23 | |
| other | Dizziness | Gastrointestinal disorders | Usual Care | 1 | 26 | |
| other | Tiredness | General disorders | NICHE Method | 0 | 23 | |
| other | Tiredness | General disorders | Usual Care | 1 | 26 | |
| other | Sleeping Poorly | General disorders | NICHE Method | 0 | 23 | |
| other | Sleeping Poorly | General disorders | Usual Care | 1 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NICHE Method | 0 | 23 |
| Total, all-cause mortality | Usual Care | 0 | 26 |
| Total, other adverse events | NICHE Method | 0 | 23 |
| Total, other adverse events | Usual Care | 3 | 26 |
| Total, serious adverse events | NICHE Method | 0 | 23 |
| Total, serious adverse events | Usual Care | 0 | 26 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR003167 | Center for Clinical and Translational Sciences (CCTS) | MCPHERSON, DAVID D; KARP, DANIEL D | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NICHE Method vs Usual Care: Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication | Trial comparisons |
| NICHE Method vs Usual Care: Number of Participants Who Self-reported Adherence to Intervention | Trial comparisons |
| NICHE Method vs Usual Care: deaths from any cause | Trial comparisons |
| NICHE Method vs Usual Care: serious adverse events | Trial comparisons |
Tests0
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03461003
GET https://conductscience.org/api/trials/v1/NCT03461003/registered