- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476512
Treatment Adherence and Blood Pressure Outcome Among Hypertensive Out-patients
Treatment Adherence and Blood Pressure Outcome Among Hypertensive Out-patients in Two Tertiary Hospitals in Sokoto, Northwestern Nigeria
It is estimated that more than 70% of patients on antihypertensive medications do not take them as prescribed. Treatment non-adherence practice may be particularly higher in developing countries where there is poor accessibility to medicines and healthcare services, coupled with low level of awareness of the lifelong nature of hypertension treatment among patients. Optimal control of blood pressure has been reported to reduce the incidence of morbidity and mortality associated with hypertension. Thus, adoption of healthy lifestyle as well as ensuring regular and continuous adherence to prescribed medications are integral to successful management of hypertension to achieve the target blood pressure goals.
The present study comprehensively evaluated adherence to pharmacotherapy and non-pharmacological measures among ambulatory hypertensive patients attending two healthcare institutions in Sokoto, Northwestern Nigeria. Reasons for treatment non-adherence were evaluated, while perception and beliefs about hypertension and its management were also explored, with pharmacist-led patient-specific adherence education provided as appropriate to resolve the knowledge gap(s). Association between treatment adherence and blood pressure outcome at contact and the subsequent 2-months clinic appointment were investigated.
Patients aged 18 years and above, with a primary diagnosis of hypertension, and who were on antihypertensive medications for at least 3-months were recruited from the medical outpatient clinic of Usmanu Danfodiyo University Teaching Hospital and the Specialist Hospital, both within Sokoto metropolis, Sokoto state, Northwestern Nigeria. Newly diagnosed patients, in-patients and those who declined participation were excluded from the study.
Study Overview
Detailed Description
Background: Hypertension is a common cardiovascular disease worldwide, contributing 4.5% of the global disease burden and 12.8% premature deaths annually. Despite recent advances in drug therapy, majority of diagnosed hypertensive patients are poorly controlled. Reasons for inadequate control of hypertension are heterogeneous including low adherence to antihypertensive medications and lifestyle changes, low compliance with scheduled follow-up visits and suboptimal pharmacotherapy. This study evaluated adherence to pharmacotherapy and non-pharmacological measures among ambulatory hypertensive patients, reasons for treatment non-adherence were evaluated, while perception and beliefs about hypertension and its management were also explored, with pharmacist-led patient-specific adherence education provided as appropriate to resolve the knowledge gap(s). Association between treatment adherence and blood pressure outcome at contact and the subsequent 2-months clinic appointment were investigated.
Method: This study involved a cross-sectional questionnaire-guided interview and retrospective review of medical records of 605-patients from two hospitals. Nine-item modified adherence predictor scale was used to assess medication adherence. Overall adherence score to lifestyle modifications was obtained from the total scores from 4-domains of non-pharmacological measures including cigarette smoking and alcohol cessation, salt-restriction and exercise. Patient-specific adherence education was provided at contact to resolve the knowledge gap(s). Clinical-parameters especially the blood pressure values were retrieved at contact and subsequent 2-months appointment. Data were summarised using frequency, percentage, 50th percentile and mean ± standard deviation. Chi-square test was used to evaluate association between socio-demographic variables and adherence to antihypertensive medication and lifestyle recommendations. Student's t-test was used to investigate relationship between treatment adherence and blood pressure outcome at p < 0.05 considered significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sokoto, Nigeria, 840252
- Usmanu Danfodiyo University Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and above, with a primary diagnosis of hypertension, and who were on antihypertensive medications for at least 3-months were enrolled.
Exclusion Criteria:
- Newly diagnosed patients, in-patients and those who declined participation were excluded from the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire with a nine-item adherence scale to assess the level of adherence to medication
Time Frame: 5 hours on Thursday clinic days, 16 weeks
|
Questionnaire with a nine-item adherence scale was used to assess the level of adherence to medication, while dichotomous Yes/No response option was used to evaluate the level of adherence to the 4-domains of non-pharmacological lifestyle modifications, specifically smoking, alcohol, exercise, and salt-restriction.
Using the Statistical Package for Social Sciences version 22 at p < 0.05 level of significance, descriptive statistics including frequency and percentage was used to summarise the data on these parameters
|
5 hours on Thursday clinic days, 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception and belief about hypertension and treatment
Time Frame: 5 hours on Thursday clinic days, 16 weeks
|
Modified Brief Illness Perception Questionnaire, and 9-item Belief bout Medicine Questionnaire with a 5-point likert scale was used to evaluate the perception and belief of patients about hypertension and the treatment.
Descriptive statistics including frequency, percentage and 50th percentile was used to summarise the data on perception and belief about hypertension and treatment, using the Statistical Package for Social Sciences version 22.
|
5 hours on Thursday clinic days, 16 weeks
|
Data collection form to retrieve the average of two consecutive blood pressure readings (Systolic and Diastolic)
Time Frame: 4 hours on Thursday clinic days, 16 weeks
|
Data collection form was designed to retrieve the average of two consecutive blood pressure readings (Systolic and Diastolic) in individual patient's case note at contact and at the 2-months clinic appointment.
Descriptive statistics including frequency, mean ± standard deviation was used to summarise these continuous variable data Chi-square and student's t-test were used to evaluate the relationship between treatment adherence and blood pressure outcome
|
4 hours on Thursday clinic days, 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAHYP001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Adherence Education
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Virginia Commonwealth UniversityCompletedAdherence, PatientUnited States
-
The University of Hong KongCompletedSleep Apnea, ObstructiveHong Kong
-
VA Office of Research and DevelopmentCompletedApnea | InsomniaUnited States
-
Case Comprehensive Cancer CenterRecruitingKeratinocyte CarcinomaUnited States
-
Case Western Reserve UniversityNational Institute of Mental Health (NIMH)CompletedBipolar Disorder | Treatment NoncomplianceUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknownEndometriosis | Ovarian Hyperstimulation Syndrome | Male Infertility | Premature Ovarian Failure | Female InfertilityNetherlands
-
Johns Hopkins All Children's HospitalCompletedSickle Cell DiseaseUnited States
-
Brigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
Columbia UniversityNational Institute on Drug Abuse (NIDA)Completed