Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2026-01-09
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Cohort 1
This cohort will be the first to participate in the ADHINCRA Program, which includes home blood pressure monitoring, an mHealth app, nurse-led lifestyle counselling and treatment with a simplified hypertension control protocol.
ADHINCRA Program
The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.
Cohort 2
This cohort will begin the ADHINCRA Program 3 months after Cohort 1.
ADHINCRA Program
The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.
Cohort 3
This cohort will begin the ADHINCRA Program 6 months after Cohort 1.
ADHINCRA Program
The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.
Cohort 4
This cohort will begin the ADHINCRA Program 9 months after Cohort 1.
ADHINCRA Program
The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.
Interventions
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ADHINCRA Program
The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmHg) on the most recent clinic visit without a diabetes diagnosis.
* Hypertension treatment naive or on monotherapy.
* Receives primary care at one of the participating sites.
* Willing and able to provide informed consent in English, Twi, Dagbani, Ewe, Hausa, or Yoruba.
* Owns a smartphone (Android or iOS).
Exclusion Criteria
* Severely elevated BP (≥180/110mmHg).
* Diagnosis of stroke, coronary artery disease, or kidney disease.
* Diagnosis of end-stage renal disease (ESRD) treated with dialysis.
* Serious medical condition which either limits life expectancy or requires active management (e.g., cancer).
* Cognitive impairment or other conditions preventing study participation
* Pregnant or currently nursing a child
* Unwilling to provide informed consent
18 Years
70 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Yvonne Commodore-Mensah, PhD, MHS, RN
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Fred S Sarfo, MBBS, PhD, FWACP
Role: PRINCIPAL_INVESTIGATOR
Kwame Nkrumah University of Science and Technology
Dike B Ojji, MBBS, PhD, FWACP
Role: PRINCIPAL_INVESTIGATOR
University of Abuja
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Dominase SDA Hospital
Bekwai, Ashanti Region, Ghana
Kumasi South Hospital
Kumasi, Ashanti Region, Ghana
Manhyia Government Hospital
Kumasi, Ashanti Region, Ghana
Tafo Government Hospital
Tafo, Ashanti Region, Ghana
Berekum Holy Family Hospital
Berekum, Bono, Ghana
St. John of God Catholic Hospital
Duayaw Nkwanta, Bono, Ghana
Northern Regional Hospital
Tamale, Northern Region, Ghana
Tamale Teaching Hospital
Tamale, Northern Region, Ghana
Ho Municipal Hospital
Ho, Volta Region, Ghana
South Tongu District Hospital
Sogakope, Volta Region, Ghana
Akure South Hospital
Akure, Ondo State, Nigeria
Akoko North East
Ondo, Ondo State, Nigeria
Akoko North West
Ondo, Ondo State, Nigeria
Akoko South East
Ondo, Ondo State, Nigeria
Akoko South West
Ondo, Ondo State, Nigeria
Owo General Hospital
Owo, Ondo State, Nigeria
Countries
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Central Contacts
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References
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Commodore-Mensah Y, Sarfo FS, Turkson-Ocran RA, Foti K, Mobula LM, Himmelfarb CD, Carson KA, Appiah LT, Degani M, Lang'at C, Nyamekye G, Molello NE, Ahima R, Cooper LA. Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial. Contemp Clin Trials. 2023 Feb;125:107077. doi: 10.1016/j.cct.2022.107077. Epub 2022 Dec 30.
Other Identifiers
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IRB00504718
Identifier Type: -
Identifier Source: org_study_id
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