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Treatment Adherence and Blood Pressure Outcome Among Hypertensive Out-patients

17 marzo 2018 aggiornato da: DR RASAQ ADISA, University of Ibadan

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

605

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Nigeria
      • Sokoto, Nigeria, 840252
        • Usmanu Danfodiyo University Teaching Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Ambulatory hypertensive patients

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Questionnaire with a nine-item adherence scale to assess the level of adherence to medication
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Perception and belief about hypertension and treatment
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Ibadan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2017

Completamento primario (Effettivo)

30 maggio 2017

Completamento dello studio (Effettivo)

30 maggio 2017

Date di iscrizione allo studio

Primo inviato

28 febbraio 2018

Primo inviato che soddisfa i criteri di controllo qualità

17 marzo 2018

Primo Inserito (Effettivo)

26 marzo 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 marzo 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 marzo 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TAHYP001

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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Sedi

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