An interventional study of HEARTS and PF in Cardiovascular Diseases, sponsored by NYU Langone Health. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
This is a hybrid type II effectiveness-implementation trial using a parallel cluster randomized design. Thirty primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria, will be randomized in a 1:1 ratio to the implementation group (Practice Facilitation [PF] + Healthy Lifestyle Counselling, Evidence-Based Protocols, Access to Essential Medicines and Technology, Risk-Based Management, Team-Based Care, and Systems for Monitoring [HEARTS] package) or the standard care group (HEARTS only)
The study comprises two phases: an R61 Initiation Phase (Years 1-2) involving adaptation of the HEARTS package guided by the chronic care model, stakeholder engagement, infrastructure development, and pilot testing in 2 PHCs; and an R33 Implementation Phase (Years 3-5) involving the cluster RCT. Once randomized, PHCs will participate in a 12-month intervention period followed by a 6-month post-implementation period.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 1,050 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The HEARTS package will be pilot tested in 2 PHCs.
Behavioral: HEARTS
PHCs assigned to the standard care group, HEARTS only.
Behavioral: HEARTS
PHCs assigned to the PF + HEARTS implementation group.
Behavioral: HEARTS · Behavioral: PF
HEARTS is a technical package intended to: 1. Identify patients with uncontrolled DM and HTN via medical history, HbA1c assessment, and lipid profile using point-of-care testing; 2. Measure patients' weight, height, waist circumference and BP with a valid automated device following standard procedures, and assess patients' CV risk with the World Health Organization (WHO) risk chart; (3) Initiate lifestyle counseling and treatment with antihypertensive and anti-diabetic medications every 1-3 months using Federal Ministry of Health simplified protocols; and (4) Refer patients to physicians.
PF involves provision of external expertise on practice redesign and a tailored approach to implementing systems-level changes to improve patient outcomes. PF includes both a role (practice facilitator) and a process for supporting PHCs to build motivation and capacity. Six practice facilitators (each responsible for 5 PHCs) will coordinate meetings with PHC nurses, assist in setting performance goals, and strategize on HEARTS implementation through onsite visits and monthly peer-to-peer telephone calls.
Implementation Fidelity of HEARTS at 12 Months
Fidelity is defined as the utilization of all components of the HEARTS program: identifying PLWH with uncontrolled hypertension (HTN) and diabetes mellitus (DM); measuring patient anthropometrics and BP; initiating lifestyle counseling and medication treatment every 1-3 months; and referring PLWH with complicated HTN and DM to physicians for further care.
Time frame: Month 12
Change in Systolic Blood Pressure (SBP) from Baseline to 12 Months
Time frame: Baseline, Month 12
Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months
Time frame: Baseline, Month 12
Sustainability of HEARTS at 18 Months
Continued utilization of HEARTS components 6 months after completion of the intervention period.
Time frame: Month 18
Blood Pressure Control at 12 Months
Proportion of study participants with blood pressure (BP) \<140/90 mm Hg at 12 months.
Time frame: Month 12
Blood Glucose Control at 12 Months
Proportion of study participants with HbA1c \<7% at 12 months.
Time frame: Month 12
Number of Sessions with Nurses
Time frame: Up to Month 12
Duration of Sessions with Nurses
Time frame: Up to Month 12
Number of Anthropometric Measurements
Total number of measurements obtained.
Time frame: Up to Month 12
Number of Lifestyle Counseling Sessions
Time frame: Up to Month 12
Number of Documented Referrals
Time frame: Up to Month 12
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nafesa.kanneh@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: Requests should be directed to Nafesa.kanneh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
Start is estimated for Sep 2027; primary completion for Feb 2030, 29 months later.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 29 months is above that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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