Project HOPE (Hypertension Outreach Through Partnership and Engagement)
ConditionHypertension (HTN)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥25 years
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)
Disqualifiers
<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)
Trial population
Adults aged 25 years and older with Stage 2 hypertension residing in five high-thoroughfare, underserved communities in Monrovia, Liberia (Zubah Town, King Gray, Barchue, Kpelle Town, and Congo Town Back Road), identified and enrolled through community-based mobile clinics (CBMCs) staffed by community health nurses (CHNs) delivering WHO-aligned hypertension treatment within the Ministry of Health's Community Health hypertension management protocols. Target enrollment is 150 patient participants. CHNs directly involved in intervention delivery are also included for pre/post-training surveys and semi-structured interviews.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Project HOPE Intervention
BehavioralPatients 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)
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Nurse-Led Community-Based Hypertension Care Cohort1 intervention
Trial outcomes
Primary outcomes
1
Change in Systolic Blood Pressure
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.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Participants with Controlled Blood Pressure
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.
Time frame
Baseline to 6 months2
Adherence (Percentage of Participants)
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.
Time frame
Baseline to 6 months3
Adherence (Proportion of medication days missed)
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.
Time frame
Baseline to 6 months4
Acceptability as assessed by the Theoretical Framework of Acceptability
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.
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Center for Advancing Health Systems Innovations (CAdHSI)
Collaborator
Wellness Partners Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: