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Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3 (HTN2)

11. Mai 2026 aktualisiert von: Mark Huffman, Washington University School of Medicine

Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design - Aim 3

The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program is to build upon the success of the first phase of the HTN Program (2020-2023), which implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the Federal Capital Territory (FCT). This program demonstrated significant improvements in hypertension treatment and control. The focus of aim 3 will be evaluating diabetes management through the implementation of the HEARTS-D bundle in 10 PHCs across the FCT that previously participated in the initial HTN Program.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

2800

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Aim 3 Inclusion Criteria:

Patients will be screened for diabetes with symptoms of hyperglycemia or BMI >25 kg/m2 and over the age of 18 years old. Upon first or previous diagnosis, diabetes patients will be registered.

  • Adults (≥18 years),
  • Patients with previous diabetes diagnosis
  • Patients with persistently elevated random glucose >200 mg/dl, fasting glucose >126 mg/dl, or hemoglobin A1c >6.5% on two or more occasions (when available)
  • Patients taking glucose lowering medications
  • Pregnant women are eligible for this program, or
  • Cognitively impaired adults are eligible for this program.

Exclusion Criteria:

  • - This program will not include any of the following special populations:

    • Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years old, or
    • Prisoners or other detained individuals.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Primary Health Care Centers in the Federal Capital Territory
10 primary healthcare centers in Nigeria's Federal Capital Territory who previously demonstrated capacity to deliver hypertension care in HTN 1.0.
Sonstiges: Implementation of program based on WHO HEARTS-D guidelines
This study uses an interrupted time series design to compare diabetes screening, diagnosis, treatment, and control across a 12-month pre-implementation period and a 24-month implementation period in 10 primary healthcare centers in Nigeria's Federal Capital Territory. Sites previously demonstrated capacity to deliver hypertension care and will continue hypertension services while expanding to diabetes care through the HEARTS diabetes module (HEARTS-D). Pre-implementation includes registry setup and provision of glucometers without diabetes treatment training. Implementation includes HEARTS-D training, supply provision, expansion of the drug revolving fund to diabetes medicines, and quarterly supportive supervision.
Arzneimittel: Metformin
Description: Oral biguanide used as first-line glucose-lowering therapy within the HEARTS-D stepped-care protocol. Dosing per protocol: 500 mg once daily (Step 1), 1000 mg once daily (Step 2), 1000 mg twice daily (Step 3 and Step 4). Supplied through the expanded drug revolving fund during the implementation period.
Arzneimittel: Glimepiride
Oral sulfonylurea used as add-on therapy at Step 4 of the HEARTS-D stepped-care protocol when blood glucose remains uncontrolled on metformin. Starting dose 1 mg once daily, titrated by 1-2 mg to a maximum of 8 mg daily. Supplied through the expanded drug revolving fund during the implementation period.
Gerät: Point-of-care blood glucose monitor (glucometer) and compatible test strips
Point-of-care capillary blood glucose monitor with compatible single-use test strips and lancets, used at participating primary health centers for diabetes screening, diagnosis, and monitoring per WHO HEARTS-D. Glucometers and test strips are provided to all sites during pre-implementation (registry setup) and replenished during implementation through the supply chain and drug revolving fund.
Andere Namen:
  • Capillary blood glucose meter
  • finger-stick glucose meter
Verhalten: HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs)
Structured training of CHEWs on the HEARTS-D protocol covering diabetes screening, diagnosis, stepped-care treatment, follow-up, and referral, delivered at the start of the implementation period and reinforced by quarterly supportive supervision visits with audit-and-feedback throughout the 24-month implementation period.
Andere Namen:
  • Provider training
  • Supportive supervision

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
Zeitfenster: 36 months
Primary Implementation Outcome: Description: Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
36 months
Difference in 6-month rolling average diabetes screening in eligible adults (random plasma glucose with hyperglycemia symptoms; fasting plasma glucose if ≥18 y and BMI >25 kg/m²; or HbA1c) per WHO HEARTS-D, pre- vs. implementation
Zeitfenster: 36 months
Primary effectiveness outcome: The primary outcome will be the difference in the 6-month rolling average of the diabetes screening among eligible patients, screening defined as a random plasma glucose screening among adults with symptoms of hyperglycemia or a fasting plasma glucose among adults > 18 years old and body mass index > 25 kg/m2 in accordance with HEARTS-D, between the pre-implementation and implementation periods. Hemoglobin A1c may also be used if available.
36 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods
Zeitfenster: 36 months
Secondary Effectiveness Outcome (diabetes treatment): 6-month rolling average of diabetes treatment levels in the pre-implementation and implementation periods.
36 months
Difference in 6-month rolling average blood sugar control (per WHO HEARTS-D: fasting plasma glucose <126 mg/dL, postprandial <160 mg/dL, or HbA1c <7%) between pre-implementation and implementation periods
Zeitfenster: 36 months
Secondary Effectiveness Outcome (blood sugar control): 6-month rolling average of blood sugar control in the pre-implementation and implementation periods. Control will be defined according to the WHO HEARTS-D module2, specifically: fasting glucose <126 mg/dl, postprandial glucose <160 mg/dl, or HbA1c <7%.
36 months
Difference in 6-month rolling average mean fasting plasma glucose (mg/dL) between pre-implementation and implementation periods
Zeitfenster: 36 months
Secondary Effectiveness Outcomes (mean fasting glucose levels): 6-month rolling average of mean fasting glucose levels in the pre-implementation and implementation periods.
36 months
Proportion of selected primary health centers (PHCs) that participated in baseline diabetes training (A ÷ B; A = PHCs that participated, B = total selected PHCs)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of PHCs who participated in baseline diabetes training B = Total number of selected PHCs

Calculation: A ÷ B
36 months
Proportion of selected PHCs that received at least one supportive supervision visit in the past 12 months (A ÷ B; B = total selected PHCs)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of PHCs who received at least one supportive supervision visit in the past 12 months B = Total number of selected PHCs

Calculation: A ÷ B
36 months
Proportion of eligible PHCs that received at least one audit-and-feedback report within the past 3 months (A ÷ B)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of PHCs who received at least an audit and feedback report within the past 3-months B = Total number of selected PHCs

Calculation: A ÷ B
36 months
Percentage of PHCs with a working blood glucose monitor on-site on the day of assessment (last supervision visit) (A ÷ B)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of PHCs with a working blood glucose monitor at the site on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs

Calculation: A ÷ B
36 months
Percentage of PHCs with diabetes medicines available on-site on the day of assessment (last supervision visit) (A ÷ B)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of PHCs with diabetes medicines available on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs

Calculation: A ÷ B
36 months
6-monthly rolling average percentage of registered diabetes patients with clinically indicated step-up who received step-up treatment within 6 months (A = patients needing and receiving step-up; B = patients registered per month)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of patients who need step up treatment and received it

B = Total number of patients who are registered per month

Calculation: A ÷ B, 6-monthly rolling average rate
36 months
6-monthly rolling average monthly proportion of registered diabetes patients receiving appropriate stepped care, out of total registered patients (A ÷ B)
Zeitfenster: 36 months

Secondary Implementation Outcome:

A = Number of patients who need step up treatment and received it

B = Total number of patients who are registered per month

Calculation: A ÷ B, 6-monthly rolling average rate
36 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in the proportion of patients with serious adverse events (SAEs) between pre-implementation and implementation periods
Zeitfenster: 36 months
Safety Outcome: between-period (pre-implementation versus implementation) differences in proportions of serious adverse events
36 months
Difference in the proportion of patients with adverse events of special interest (hypoglycemia, hyperglycemia, medication allergies, common medication side effects) between pre-implementation and implementation periods
Zeitfenster: 36 months
Safety Outcome: e.g., hypoglycemia, hyperglycemia, medication allergies, common medication side effects in pre-implementation and implementation periods.
36 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Washington University School of Medicine

Mitarbeiter

National Heart, Lung, and Blood Institute (NHLBI)
University of Abuja Teaching Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

30. April 2029

Studienabschluss (Geschätzt)

31. Januar 2030

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UATH/HREC/PR/557/A3
  • R01HL144708 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual patient data will be shared through NHLBI BioData Catalyst

IPD-Sharing-Zeitrahmen

Data will be available within 1 year of study conclusion

IPD-Sharing-Zugriffskriterien

Access to study data will be managed through NHLBI BioData Catalyst.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Bedingungen

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