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CompletedNCT03476512Updated Mar 26, 2018

Treatment Adherence and Blood Pressure Outcome Among Hypertensive Out-patients

An observational study in Hypertension, sponsored by University of Ibadan. Completed at 1 site in Nigeria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-26.

Sponsored by University of Ibadan · Observational

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Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
605
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 31 studies in Hypertension with a site in Nigeria — 11 open to participants now, 14 under way, none of them phase 3. Hypertension · Nigeria.

Enrollment
7th of 10
605 · median 2,915
Started
2017
with 3 others
Observational
10 of 31
5 open now
Registered
9th of 31
by date
Lead sponsor
4 of 31
University of Ibadan

Among the 31 studies in Hypertension with a site in Nigeria, this one is the 7th largest by enrollment of the 10 observational ones that give a count, is one of 4 that started in 2017, is one of 10 observational ones, and was the 9th registered.

Hypertension

6,120 studies on the registry are indexed under Hypertension; 913 are open to participants now.

Browse Hypertension studies →

Open to participants now

11 of the 31 studies in Hypertension with a site in Nigeria are open now. Recruiting first, the newest first:

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All 11 open studies →

A study can be open while its sites in Nigeria have not opened yet or have stopped. Only those recruiting at a site in Nigeria →

Who these studies take

Of the 563 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (36%) stop at 75 or younger; 40 take children under 18; 139 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Hypertension

Keywords

  • Treatment adherence
  • Ambulatory hypertensive patients
  • Blood pressure
  • Non-pharmacological measures
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ambulatory hypertensive patients

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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

Exclusion Criteria:

  • Newly diagnosed patients, in-patients and those who declined participation were excluded from the study
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
605 participants (actual)
Patient registry
No

Interventions

  • OtherAdherence Education

    Patients were given adherence education to resolve the identified deficits

06

What researchers measure

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

    Time frame: 5 hours on Thursday clinic days, 16 weeks

Secondary outcomes

  1. Perception and belief about hypertension and treatment

    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.

    Time frame: 5 hours on Thursday clinic days, 16 weeks

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

    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

    Time frame: 4 hours on Thursday clinic days, 16 weeks

07

Study locations

1 site
  • Usmanu Danfodiyo University Teaching Hospital
    Sokoto, 840252, Nigeria
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in May 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Mar 26, 2018
StartActual
Feb 1, 2017
Primary completionActual
May 30, 2017
CompletionActual
May 30, 2017
Last update
Mar 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03476512
Lead sponsor
University of Ibadan
Responsible party
DR RASAQ ADISA (Director, Medication Therapy Management Research in Communicable and non-communicable, University of Ibadan) — Principal investigator
First posted
Mar 26, 2018
Start date
Feb 1, 2017
Primary completion
May 30, 2017
Completion
May 30, 2017
Last update
Mar 26, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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