Recruiting NCT06986590
Addressing Hypertension Care in Africa Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADHINCRA Program.
- Who it may be relevant to
- Registry conditions: Hypertension, High Blood Pressure. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Ghana, Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Addressing Hypertension Care in Africa (ADHINCRA) Program
Overview
The ADHINCRA Program is a bundle of multilevel evidence-based interventions that address multiple predictors of controlled hypertension, including patient-, provider-, and health system-level factors. The successful implementation of the ADHINCRA program will provide a rigorous and scalable model for improving hypertension control in Africa, which would ultimately reduce the risk of cardiovascular disease, stroke and kidney disease.
Interventions
- Behavioral 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.
Primary outcome measures
- Number of participants with systolic blood pressure <140 mmHg [Time frame: Baseline and 12 months post-randomization]
Secondary outcome measures (4)
- Number of participants with diastolic blood pressure <90 mmHg [Time frame: Baseline, 12 months, 24 months post-randomization]
- Medication adherence as assessed by Hill-Bone Medication Adherence Scale [Time frame: Baseline, 12 months, 24 months post-randomization]
- Percentage of sites that adopt and maintain the intervention as assessed by the Pragmatic Robust Implementation and Sustainability Model [Time frame: Baseline, 12 months, 24 months post-randomization]
- Difference in cost of intervention compared to usual care as assessed by the Pragmatic Robust Implementation and Sustainability Model [Time frame: Baseline, 12 months, 24 months post-randomization]
Eligibility criteria
Inclusion criteria
- Aged 18 -70 years.
- 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
- Age <18 years or >70 years.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Ghana · 10 centers
- Dominase SDA Hospital — Bekwai
- Kumasi South Hospital — Kumasi
- Manhyia Government Hospital — Kumasi
- Tafo Government Hospital — Tafo
- Berekum Holy Family Hospital — Berekum
- St. John of God Catholic Hospital — Duayaw Nkwanta
- Northern Regional Hospital — Tamale
- Tamale Teaching Hospital — Tamale
- … and 2 more centers
Nigeria · 6 centers
- Akure South Hospital — Akure
- Akoko North East — Ondo
- Akoko North West — Ondo
- Akoko South East — Ondo
- Akoko South West — Ondo
- Owo General Hospital — Owo
United States · 1 center
- Johns Hopkins University — Baltimore
Publications
- 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. PMID 36592818
Identifiers
NCT: NCT06986590 · IRB00504718 · 1R01HL175642-01