Who is sponsoring NCT03577990?

NCT03577990 is sponsored by University of North Carolina, Charlotte.

What drugs are being tested in NCT03577990?

Interventions in NCT03577990: Interactive Technology Enhanced Coaching (ITEC), Interactive Technology-No Coaching (IT).

What condition does NCT03577990 study?

NCT03577990 studies Uncontrolled Hypertension.

Is NCT03577990 still recruiting?

NCT03577990 is currently completed. Last updated 17 May 2023.

Are results published for NCT03577990?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-17 · How we verify

NCT03577990

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Technology Coaching Intervention for Black Women With Hypertension

Completed NA Results posted Last updated 17 May 2023

What this trial tests

NA trial testing Interactive Technology Enhanced Coaching (ITEC) in Uncontrolled Hypertension in 90 participants. Completed in 16 April 2021.

Timeline

28 January 2019

Primary endpoint
16 April 2021

16 April 2021

Quick facts

Lead sponsor	University of North Carolina, Charlotte
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	28 January 2019
Primary completion	16 April 2021
Estimated completion	16 April 2021
Sites	1 location across United States

Drugs / interventions tested

Interactive Technology Enhanced Coaching (ITEC)
Interactive Technology-No Coaching (IT)

Conditions studied

Uncontrolled Hypertension — all drugs for Uncontrolled Hypertension →

Sponsor

University of North Carolina, Charlotte

Who can join

Adults 18 to 70, female only, with Uncontrolled Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Systolic and Diastolic Blood Pressure (BP) Primary · Baseline to 3 months, 6 months, and 9 months.

To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.

Baseline Systolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	140.07	± 1.5781
Interactive Technology-No Coaching (IT)	139.03	± 1.6841

Month 3 Systolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	124.18	± 1.9429
Interactive Technology-No Coaching (IT)	128.31	± 1.9737

Month 6 Systolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	125.80	± 1.9606
Interactive Technology-No Coaching (IT)	126.13	± 2.0827

Month 9 Systolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	125.04	± 1.7349
Interactive Technology-No Coaching (IT)	125.67	± 1.8618

Baseline Diastolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	83.8578	± 1.2306
Interactive Technology-No Coaching (IT)	84.3161	± 1.3132

Month 3 Diastolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	82.8319	± 1.4629
Interactive Technology-No Coaching (IT)	79.9767	± 1.4749

Month 6 Diastolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	83.2099	± 1.3628
Interactive Technology-No Coaching (IT)	82.3126	± 1.4482

Month 9 Diastolic BP

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	82.5838	± 1.4368
Interactive Technology-No Coaching (IT)	81.6017	± 1.5639

Medication Adherence by Proportion of Days Covered Secondary · Month 1 to Month 3, Month 6, and Month 9.

To show the proportion of days covered in the period of interest (Month 1, Month 3, Month 6, and Month 9). (Sum of days covered that participant reported medication adherence in the period of interest) ÷ (the number of days in the period of interest) x 100.

Month 1 Med Adherence

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	0.7404	± 0.06353

Month 3 Med Adherence

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	0.6507	± 0.06353

Month 6 Med Adherence

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	0.5575	± 0.06353
Interactive Technology-No Coaching (IT)	0.5357	± 0.06779

Month 9 Med Adherence

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	0.6507	± 0.06353
Interactive Technology-No Coaching (IT)	0.5595	± 0.06779

Physical Activity (Change in Daily Steps) Secondary · Month 1 to Month 3, Month 6, and Month 9.

To show the change (increase) in daily steps over 9 months.

Month 1 Steps

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	5778.58	± 555.38

Month 3 Steps

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	5384.34	± 593.17

Month 6 Steps

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	4720.90	± 611.08
Interactive Technology-No Coaching (IT)	6413.73	± 663.43

Month 9 Steps

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	4743.20	± 770.29
Interactive Technology-No Coaching (IT)	5092.30	± 798.81

Change in Dietary Intake (Calories) Secondary · Month 1 to Month 3, Month 6, and Month 9.

To show the change (decrease) in dietary intake (calories) over 9 months.

Month 1 Calories

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	1204.75	± 81.7083

Month 3 Calories

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	1133.66	± 92.0513

Month 6 Calories

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	801.42	± 96.8770
Interactive Technology-No Coaching (IT)	803.38	± 122.88

Month 9 Calories

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	1247.33	± 146.01
Interactive Technology-No Coaching (IT)	1029.74	± 165.78

Change in Weight Secondary · Baseline to 3 months, 6 months, and 9 months.

To show the change (decrease) in weight over 9 months.

Baseline Weight

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	213.54	± 7.6390
Interactive Technology-No Coaching (IT)	214.31	± 8.1523

Month 3 Weight

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	205.23	± 7.6767
Interactive Technology-No Coaching (IT)	212.20	± 8.1523

Month 6 Weight

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	203.71	± 7.7075
Interactive Technology-No Coaching (IT)	203.71	± 8.2126

Month 9 Weight

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	202.36	± 7.8919
Interactive Technology-No Coaching (IT)	205.40	± 8.4171

Change in Dietary Intake (Sodium) Secondary · Month 1 to Month 3, Month 6, and Month 9.

To show the change (decrease) in dietary intake (sodium) over 9 months.

Month 1 Sodium

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	1363.65	± 116.66

Month 3 Sodium

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	1386.61	± 134.26

Month 6 Sodium

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	775.66	± 141.33
Interactive Technology-No Coaching (IT)	928.30	± 181.33

Month 9 Sodium

Group	Value	95% CI
Interactive Technology Enhanced Coaching (ITEC)	1226.89	± 179.26
Interactive Technology-No Coaching (IT)	1512.05	± 241.61

Adverse events — posted to ClinicalTrials.gov

Time frame: 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Interactive Technology Enhanced Coaching (ITEC)

Serious: 9/42 (21%)

Deaths: 0/42

Interactive Technology-No Coaching (IT)

Serious: 3/41 (7%)

Deaths: 0/41

Serious adverse events (12 terms)

Reaction	System	Interactive Technology Enh…	Interactive Technology-No …
Stroke	Vascular disorders	—	—
Elevated diastolic blood pressure >110	Vascular disorders	—	—
Dislodged patella	Musculoskeletal and connective tissue disorders	—	—
Twisted ankle	Musculoskeletal and connective tissue disorders	—	—
Bunion surgery	Surgical and medical procedures	—	—
Total knee replacement	Surgical and medical procedures	—	—
Shoulder replacement	Surgical and medical procedures	—	—
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Glaucoma	Surgical and medical procedures	—	—
Abdominal pain and bleeding	Gastrointestinal disorders	—	—
Stomach virus	Gastrointestinal disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Stroke, Elevated diastolic blood pressure >110, Dislodged patella, Twisted ankle, Bunion surgery, Total knee replacement, Shoulder replacement, Cancer.

Data from ClinicalTrials.gov NCT03577990 adverse events section.

Sponsor's own description

Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of HTN in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling HTN using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive the Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and weight management) post intervention compared to participants receiving self-care management alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Correction to "Use of Coaching and Technology to Improve Blood Pressure Control in Black Women With Hypertension: Pilot Randomized Controlled Trial Study".
· 2025 · PMID 41117738 · DOI 10.1111/jch.70085

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03577990 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Charlotte
Last refreshed: 17 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03577990.

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