A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London
About this trial
This study includes a survey of primary healthcare facilities in Nigeria and Sri Lanka. It will aim to assess the availability and readiness of hypertension care in primary healthcare facilities, and feasibility to conduct a future randomised controlled trial.
This study also includes a survey of patients with high blood pressure who will be recruited from primary care in Sri Lanka and Nigeria. Its aim is to understand the characteristics of patients with hypertension, hypertension management and control, including use of pharmacological interventions and lifestyle management. Patients will have their blood pressure, height and weight measured. They will also be asked about their age, sex/gender, socio-economic status, medical history, and health behaviours and lifestyle.
Additionally, this study includes focus group discussions and in-depth interviews with adults with high blood pressure and their carers; healthcare providers (community health workers, nurses, and doctors or physicians); clinic administrators; and policymakers. The discussions and interviews will aim to explore experiences, practices, and views on hypertension care and the new treatment strategies. Topics will cover experiences of current high blood pressure care; service availability, accessibility, and affordability; healthcare staff training and how well they follow medical guidelines for helping patients with high blood pressure; what works well and what are the problems with helping patients with high blood pressure; experiences of patients who need help with their high blood pressure; and how well new ways of helping people with high blood pressure are received.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adult (age ≥18 years)
hypertensive (defined as prior documented diagnosis of hypertension, or current use of BP-lowering drugs for hypertension, or SBP ≥140 mmHg, and/or DBP ≥90 mmHg measured on two separate occasions)
Disqualifiers
receiving BP-lowering drugs for conditions other than hypertension (e.g., benign prostate hyperplasia, migraine, etc)
normotensive
Trial population
Facility Survey (SARA): This survey will be conducted in family medicine clinics within primary care facilities where most patients with hypertension are managed. Patient Cross-Sectional Survey: Adults with hypertension attending primary healthcare facilities screened as part of Facility Survey (SARA) in Nigeria and Sri Lanka. Group Discussions and In-Depth Interviews: Participants will include adults with hypertension and their carers; healthcare providers (community health workers, nurses, and doctors or physicians); clinic administrators; and policymakers.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,357 Participants
are grouped into 3 trial groupsGroup A: Cross-Sectional Facility Survey (SARA)
Group B: Cross-Sectional Patient Survey
Group C: Qualitative Focus Groups Discussions and In-Depth Interviews
Trial outcomes
Primary outcomes
1
prevalence of hypertension control
Hypertension is defined as prior documented diagnosis of hypertension, or current use of Blood Pressure (BP) lowering drugs for hypertension, or Systolic Blood Pressure (SBP) ≥140 mmHg, and/or Diastolic Blood Pressure (DBP) ≥90 mmHg measured on two separate occasions. Hypertension control is defined as achieving SBP \< 140 mmHg and DBP \< 90 mmHg with BP-lowering medications. The prevalence will be estimated separately for Nigeria and Sri Lanka.
Time frame
Baseline (this cross-sectional survey includes a single study visit)Secondary outcomes
1
factors associated with poor control of hypertension
Multilevel logistic regression with clustering by primary healthcare centre (random intercept) will be used. Covariate selection will be guided by a conceptual framework; core adjustments will include age, sex, treatment status, and comorbidity.
Time frame
Baseline (this cross-sectional survey includes a single study visit)Other outcomes
1
Availability of infrastructure and human and other resources for hypertension care
A structured facility survey will be administered using and an adapted version of WHO's Service Availability and Readiness Assessment tool. Descriptive statistics will be used to summarise facility characteristics.
Time frame
Baseline (data is collected during a single study visit in this facility cross-sectional survey)2
Experiences of hypertension care
Experiences of hypertension care will be explored through qualitative data collected during focus group discussions and in-depth interviews.
Time frame
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)3
Perceptions of hypertension care
Perceptions of hypertension care will be explored through qualitative data collected during focus group discussions and in-depth interviews.
Time frame
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)4
Appropriateness of new hypertension treatment strategies
Participants' perceptions of the appropriateness of new treatment strategies for hypertension management in primary care will be explored through focus group discussions and in-depth interviews.
Time frame
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
University of Abuja
Collaborator
RemediumOne
Collaborator
University of Kelaniya
Collaborator
The George Institute
Collaborator
The George Institute for Global Health, Australia
Collaborator
The University of New South Wales
Collaborator
Source ClinicalTrials.gov