Project HOPE (Hypertension Outreach Through Partnership and Engagement) (HOPE)
The goal of this study is to learn if a nurse-led, task-shifting, community-based program can help lower blood pressure in adults aged 25 and older with uncontrolled high blood pressure (hypertension) in Monrovia, Liberia. The program is delivered through community-based mobile clinics by community health nurses (CHNs) trained in WHO-aligned hypertension care within the Ministry of Health's (MOH) Community Health hypertension management protocols.
Participants will:
- Receive blood pressure treatment from trained community health nurses (CHNs) at community-based mobile clinics in their communities, including medication and lifestyle counseling.
- Complete surveys at their first visit, at 4 to 6 weeks, and at 3 months about their experience, satisfaction, and medication use.
- Attend follow-up visits at the mobile clinic based on their blood pressure levels.
Community health nurses delivering the program will complete structured training and be invited to complete surveys before and after training, and to take part in interviews about their experience at the end of the study.
The study will take place over 7 months in five high-thoroughfare communities in Monrovia, Liberia, and aims to enroll 150 participants.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This pilot uses a quasi-experimental, hybrid type 1 effectiveness-implementation design to assess both the clinical effectiveness and implementation outcomes of a nurse-led, community-based hypertension intervention in an urban Liberian setting. The intervention is embedded within the Ministry of Health's (MOH) National Community Health Strategy 2023-2032 and operationalizes the MOH's new Community Health hypertension management protocols, which adapt WHO pharmacologic and non-pharmacologic guidelines to the local context.
Care is delivered by community health nurses (CHNs) operating out of community-based mobile clinics (CBMCs) sited in five contiguous, high-thoroughfare communities (Zubah Town, King Gray, Barchue, Kpelle Town, and Congo Town Back Rd). The communities are within 15-20 minutes of each other to support shared logistics and continuity of care across mobile clinic visits. Recruitment occurs over the first 3 months of the 7-month pilot period; each enrolled participant is then followed for 3 months.
CHNs complete a multi-day, competency-based training program led by the Johns Hopkins Center for Health Equity (JHCHE) in partnership with the Liberian implementation team. Training covers standardized BP measurement using a "screen and confirm" protocol (including a 5-minute pre-measurement rest and automated triplicate readings), WHO-aligned pharmacologic step-up algorithm adapted to local formulary and context, and structured non-pharmacologic counseling using a patient-facing Options Tool adapted from the RICH LIFE trial (covering diet, physical activity, smoking cessation, adherence support, danger-sign recognition, and social drivers of hypertension). Motivational interviewing techniques and simplified treatment protocols under physician oversight follow the Addressing Hypertension Care in Africa (ADHINCRA) model. Ongoing technical assistance and remote protocol-fidelity monitoring are provided by the JHCHE team.
The study is being conducted under a dual-Institutional Review Board (IRB) structure: the Liberian team holds local IRB approval for the patient-care component, while Johns Hopkins Medicine (JHM) IRB approval covers all CHN-facing research activities and a secondary evaluation of patient outcomes using the limited data set. The work is intended to generate real-world evidence to inform scale-up of equitable, nurse-led chronic disease care across urban and peri-urban communities in Liberia and comparable health systems.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Lisa A Cooper, MD, MPH
- Telefonní číslo: 410-955-3008
- E-mail: lisa.cooper@jhmi.edu
Studijní záloha kontaktů
- Jméno: Nicole Cooper, MD, MPH
- Telefonní číslo: +231-555-395-650
- E-mail: medicaldirector@wellnesspartnershealth.org
Studijní místa
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Montserrado County
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Monrovia, Montserrado County, Libérie
- Wellness Partners Clinic
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Kontakt:
- Nicole Cooper, MD, MPH
- Telefonní číslo: +231-555-395-650
- E-mail: medicaldirector@wellnesspartnershealth.org
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Kontakt:
- Cooper
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Vrchní vyšetřovatel:
- Nicole Cooper, MD, MPH
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Patient Participant Inclusion Criteria:
- Adults aged ≥25 years
Stage 2 hypertension defined as either:
- Systolic Blood Pressure (SBP) ≥160 mmHg at screening (Group A); OR
- SBP 140-159 mmHg at screening with either documented elevation on more than one visit or a known history of hypertension (e.g., prior clinician diagnosis or current use of antihypertensive medication) (Group B)
Patient Participant Exclusion Criteria:
- <25 years of age
- Hypertensive emergency with SBP ≥180 mmHg at screening (these patients will be referred to the nearest health center per local protocol; they may be re-screened for eligibility at a subsequent visit if SBP meets the inclusion criteria above)
- Diagnosis of end-stage renal disease (ESRD)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- Cognitive impairment or other condition preventing participation in the intervention
- Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥30 days), screened using the NIAAA Single Alcohol Screening Question
- Pregnant or planning pregnancy in the next 24 months
- Currently nursing a child
- Current participation in another research study focused on reducing blood pressure
- Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
- Planning to move out of the geographic area within 7 months
- Unwillingness to provide informed consent
Community Health Nurse (CHN) Participant Inclusion Criteria:
- CHNs who were directly involved in delivering the nurse-led community-based hypertension intervention
- Willing to provide oral informed consent for participation in pre/post-training surveys and semi-structured interviews
Community Health Nurse (CHN) Participant Exclusion Criteria:
- CHNs who were not directly involved in the delivery of the intervention
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Nurse-Led Community-Based Hypertension Care Cohort
The source population will be community residents living in high thoroughfare areas within five communities (Zubah Town, King Gray, Barchue, Kpelle Town and Congo Town Back Rd) in Monrovia, Liberia.
The designated communities are within 15-20 minutes of each other.
Patients can receive care at a neighboring site if they miss the day of the week when the clinic is set up in their neighborhood.
Patients and community health promoters will have a schedule for all five days that the mobile clinic will move through these communities.
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Patients will receive nurse-led treatment for uncontrolled hypertension that includes: A. Pharmacological treatment in line with the MOH's non-communicable disease protocols and World Health Organization (WHO) Guidelines for the pharmacological treatment of hypertension in adults 1. Medications include calcium channel blockers, thiazide diuretics, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). B. Non-pharmacological treatment including education and counseling on lifestyle interventions (healthy diet, exercise, active non-sedentary lifestyle +/- smoking cessation as needed), medication adherence, danger signs and social factors contributing to hypertension. The mobile clinics will be in the same community at a specific day of the week, each week, enabling patients to come back for a follow-up on the same day during a future week (either next week or after 4-6 weeks, based on blood pressure readings) |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Systolic Blood Pressure
Časové okno: Baseline to 6 months
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Within subject change from baseline in systolic blood pressure at the last measurement will be calculated. We will report the mean (95% confidence interval (CI)) in the change. A reduction in systolic blood pressure of ≥ 5 mmHg will be considered clinically significant. A ≥5 mmHg reduction would be considered clinically meaningful/significant but this will not stop medication titration. Patients showing improvement but still uncontrolled will continue escalation per protocol. |
Baseline to 6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participants with Controlled Blood Pressure
Časové okno: Baseline to 6 months
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The percent and exact binomial 95% CI of participants with controlled blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) at their last visit will be calculated.
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Baseline to 6 months
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Adherence (Percentage of Participants)
Časové okno: Baseline to 6 months
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Medication adherence will be measured at the last visit using a self-report measure of the extent of medical nonadherence by Voils which included three questions: A. I took all doses of my blood pressure medication. B. I missed or skipped at least one dose of my blood pressure medication. C. I was not able to take all of my blood pressure medication. If the participant reports being non-adherent on any of the three adherence yes/no questions, the participant will be coded as non-adherent. If they report being adherent on all three questions they will be coded as adherent. The percent and exact binomial 95% CI for adherent will be reported. |
Baseline to 6 months
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Adherence (Proportion of medication days missed)
Časové okno: Baseline to 6 months
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Thee proportion of days (out of 7) that the participant missed taking medications using a single-item self-report medication adherence question and report the mean proportion and 95% CI will be reported.
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Baseline to 6 months
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Acceptability as assessed by the Theoretical Framework of Acceptability
Časové okno: Baseline to 6 months
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The investigators will measure four constructs: (a) affective attitude, (b) burden, (c) perceived effectiveness, and (d) opportunity costs, and the (e) overall acceptability rating from the theoretical framework of acceptability (TFA).
Items (a) and (b) will be scored such that a score of 1 represents the least desirable response and a score of 5 represents the most desirable response.
Items (c), (d) and (e) will have yes/no responses.
A composite/summary measure will be created by dichotomizing the 5-point items (Yes = 4 and 5 vs No =1, 2, and 3).
Then, a sum of the number of positive responses on the 5 items will be created.
A score of 4 on this composite/summary measure (score range: 0-5, higher score better) would be considered ≥ 80% acceptability and would be considered a success at the last visit.
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Baseline to 6 months
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Satisfaction and Trust
Časové okno: Baseline to 6 months
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The investigators will measure participant satisfaction and trust using the single item questions.
The mean and 95% CI of the responses will be reported.
A score of ≥ 4.0 will indicate satisfaction or trust, respectively.
These questions are scored using a Likert's scale (score range: 1-5, higher score better) with the following options and scores: Strongly Disagree (1), Disagree (2), Neither Agree nor Disagree (3), Agree (4) Strongly Agree (5)
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Baseline to 6 months
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Study Completion
Časové okno: Baseline to 6 months
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The proportion and 95% CI of the participants who did not complete the study will be reported.
If available, reasons for withdrawal will also be reported.
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Baseline to 6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Lisa A Cooper, MD, MPH, Johns Hopkins University
- Vrchní vyšetřovatel: Nicole Cooper, MD, MPH, Wellness Partners Clinic
Publikace a užitečné odkazy
Obecné publikace
- Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121.
- Ogedegbe G, Plange-Rhule J, Gyamfi J, Chaplin W, Ntim M, Apusiga K, Iwelunmor J, Awudzi KY, Quakyi KN, Mogaverro J, Khurshid K, Tayo B, Cooper R. Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana. PLoS Med. 2018 May 1;15(5):e1002561. doi: 10.1371/journal.pmed.1002561. eCollection 2018 May.
- Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
- 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.
- Cooper LA, Marsteller JA, Carson KA, Dietz KB, Boonyasai RT, Alvarez C, Ibe CA, Crews DC, Yeh HC, Miller ER 3rd, Dennison-Himmelfarb CR, Lubomski LH, Purnell TS, Hill-Briggs F, Wang NY; RICH LIFE Project Investigators. The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities. Am Heart J. 2020 Aug;226:94-113. doi: 10.1016/j.ahj.2020.05.001. Epub 2020 May 8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB00520896
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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