NCT03476512

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
605

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

February 28, 2018

Last Update Submit

March 17, 2018

Conditions

Keywords

Treatment adherenceAmbulatory hypertensive patientsBlood pressureNon-pharmacological measures

Outcome Measures

Primary Outcomes (1)

  • Questionnaire with a nine-item adherence scale to assess the level of adherence to medication

    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 Outcomes (2)

  • Perception and belief about hypertension and treatment

    5 hours on Thursday clinic days, 16 weeks

  • Data collection form to retrieve the average of two consecutive blood pressure readings (Systolic and Diastolic)

    4 hours on Thursday clinic days, 16 weeks

Interventions

Patients were given adherence education to resolve the identified deficits

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory hypertensive patients

You may qualify if:

  • 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.

You may not qualify if:

  • Newly diagnosed patients, in-patients and those who declined participation were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usmanu Danfodiyo University Teaching Hospital

Sokoto, 840252, Nigeria

Location

MeSH Terms

Conditions

HypertensionTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Medication Therapy Management Research in Communicable and non-communicable

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 26, 2018

Study Start

February 1, 2017

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

March 26, 2018

Record last verified: 2018-03

Locations