NCT03724487: Coachman

A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement

Completed NA Results posted Last updated 16 August 2022

What this trial tests

NA trial testing Coachman in Hypertension in 60 participants. Completed in 1 May 2020.

Timeline

1 March 2019

Primary endpoint
30 November 2019

1 May 2020

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	1 March 2019
Primary completion	30 November 2019
Estimated completion	1 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Coachman
• Enhanced Usual Care (EUC)

Conditions studied

• Hypertension — all drugs for Hypertension →
• Self-management — all drugs for Self-management →
• Technology — all drugs for Technology →
• Community-based Participatory Research — all drugs for Community-based Participatory Research →

Sponsor

Case Western Reserve University

Who can join

30 and older, any sex, with Hypertension or Self-management. 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 Primary · baseline and 12 weeks

The primary outcome was a change (reduction) in both the systolic and diastolic blood pressure from baseline to 12 weeks, in which the 12 weeks mean systolic minus the baseline systolic were calculated. The same for 12 week diastolic BP minus the baseline diastolic BP were calculated for a mean change score. The change score (number) can range from no change (0) to a 10 point reduction in blood pressure.

Systolic Blood Pressure Change from baseline at 12 weeks

Group	Value	95% CI
Coachman	0.55	± 1.84
Enhanced Usual Care (EUC)	-2.17	± 0.51

Diastolic Blood Pressure Change from baseline at 12 weeks

Group	Value	95% CI
Coachman	-0.80	± 2.00
Enhanced Usual Care (EUC)	-1.04	± 0.55

Change in PROMIS Global Health-10 [Health-related Quality of Life] Primary · Baseline and 12-weeks

Change in PROMIS Global Health-10 score (two subscales- Mental and Physical Health) from baseline to 12 weeks. Raw scores range from 4-20, higher scores represent better health. The change score is calculated as a mean difference between the two scores: at baseline and at 12 weeks. Scores are reported as a change value number, on a continuous number scale, that can be negative or positive (0 to 1, higher number better health).

Chang in PROMIS Global Health-Metal Health Subscale

Group	Value	95% CI
Coachman	0	± 0.30
Enhanced Usual Care (EUC)	0.34	± 0.93

Changes in PROMIS Global Health-Physical Health Subscale

Group	Value	95% CI
Coachman	-0.11	± 0.16
Enhanced Usual Care (EUC)	-0.11	± 0.09

Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks Secondary · 12 weeks

Achieved Blood Pressure target is defined as the rate of participants that have a blood pressure of at the end of 12 weeks, \< 130 mm Hg for systolic blood pressure and \<80 mmHg diastolic blood pressure, in the intervention group. Percentage of individuals that achieved blood pressure target can range from 0 -100%

Group	Value	95% CI
Coachman	22

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Coachman

Serious: 0/30 (0%)

Deaths: 0/30

Enhanced Usual Care

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	Coachman	Enhanced Usual Care
Hypertensive Crisis or urgency	Vascular disorders	—	—

Most-reported serious reactions: Hypertensive Crisis or urgency.

Data from ClinicalTrials.gov NCT03724487 adverse events section.

Sponsor's own description

The prevalence of hypertension among U.S. adults increased from 32% to 46% and African Americans are disproportionately impacted. Self-managing hypertension presents challenges such as dealing with complex treatment regimen, including critical components of recommended hypertension treatment such as self-blood pressure monitoring, and lifestyle modifications involving diet, exercise, and tobacco cessation. African Americans with hypertension have lower adherence to self-management behavior due to multifactorial reasons. Substantial evidence has demonstrated the important role of community support in improving patients' self-management of a variety of chronic illnesses, though integrating technology in such programs are rarely offered.

The purpose of this study is to investigate the effectiveness of a community outreach program using a technology-based intervention (TBI) to support self-managing hypertension (called COACHMAN) to improve BP control.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.