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ECHO-COPD: Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention Among COPD Patients (ECHO-COPD)

7 settembre 2026 aggiornato da: Rabia Hussain

Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention on Medication Adherence, Quality of Life, and Direct Cost Among COPD Patients at Buraidah Central Hospital in Al-Qassim Region, Saudi Arabia: A Quasi-Experimental Design

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease associated with substantial morbidity and mortality, impaired quality of life, and healthcare costs. Medication adherence and appropriate self-management are important components of COPD management; however, patients' health beliefs and perceptions may influence their adherence to treatment and engagement in recommended health behaviours. This study aims to evaluate the impact of a pharmacist-led educational intervention based on the Health Belief Model (HBM) on medication adherence, quality of life, and direct healthcare costs among patients with COPD receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia.

A quantitative, quasi-experimental pretest-posttest control-group design will be used. Eligible COPD patients will be non-randomly assigned to either an intervention group or a control group. The intervention group will receive structured, pharmacist-led HBM-based educational sessions in addition to routine care. In contrast, the control group will continue to receive standard care without additional educational input. Baseline assessments will include medication adherence using the 8-item Morisky Medication Adherence Scale (MMAS-8); quality of life and health status using the COPD Assessment Test (CAT); health beliefs using a structured HBM questionnaire; and direct medical costs obtained from the hospital clinical cost centre. The educational intervention will be delivered over six months, followed by post-intervention assessment using the same outcome measures.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The HBM will guide the content and delivery of the pharmacist-led educational intervention. The intervention will address the six core constructs of the HBM:

  1. Perceived susceptibility
  2. Perceived severity
  3. Perceived benefits
  4. Perceived barriers
  5. Cues to action
  6. Self-efficacy The purpose of applying the HBM is to influence patients' understanding of COPD and promote positive behavioural changes, particularly improvements in medication adherence. The study will then examine the relationship between these improvements and quality of life, healthcare utilisation, and direct healthcare costs.

The intervention will consist of structured face-to-face educational sessions conducted in the designated counselling room of the Pulmonary Department at BCH. Sessions will incorporate printed educational materials, lectures, counselling, practical demonstrations, motivational support, problem-solving strategies, and reinforcement of behavioural changes.

The educational programme will cover aspects of COPD management, medication adherence and appropriate medication use, COPD risk factors and complications, nutrition and preventive care, smoking cessation, barriers to recommended behaviours, cues to action, and strategies to improve patients' confidence in managing COPD.

Participants in the intervention and control groups will undergo pre-intervention assessments. Participants in the intervention group will subsequently receive the structured educational programme, while the control group will continue to receive standard care without additional educational input. Post-intervention assessments will use the same measurement instruments to allow within-group and between-group comparisons.

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Non applicabile

Contatti e Sedi

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

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Arabia Saudita
    • Al-Qassim Region
      • Buraidah, Al-Qassim Region, Arabia Saudita, 52391
        • Bander S Alshammeri
        • Contatto:

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

Participants must:

  1. Be adults aged 18-65 years.
  2. Be diagnosed with COPD stages I-III according to GOLD guidelines.
  3. Have visited or been admitted for a COPD exacerbation and be receiving care at BCH in Al-Qassim Region, Saudi Arabia.
  4. Be Arabic-speaking and capable of understanding study instructions.
  5. Be willing and able to provide written informed consent.

Exclusion Criteria:

Participants will be excluded if they:

  1. Are diagnosed with COPD stage IV.

  2. Have another significant pulmonary disease, including:

    • Asthma
    • Bronchiectasis
    • Pneumonia
    • Cystic fibrosis

  3. Have a serious systemic illness, severe comorbidity, or central organ dysfunction, including:

    • Hepatic dysfunction
    • Renal dysfunction
    • Psychiatric impairment
    • Sensory impairment
  4. Are immunocompromised or receiving immunosuppressive treatment.
  5. Have psychological, sensory, or cognitive impairment that prevents meaningful participation in 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

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: HBM-Based Educational Intervention

Participants in the intervention group will receive routine care together with structured pharmacist-led educational sessions based on the HBM.

The educational intervention will be conducted face-to-face during scheduled outpatient appointments in the designated counselling room of the Pulmonary Department.

The programme will be delivered from study months 4 to 9.

Educational sessions will include:

  • Printed educational materials
  • Lectures
  • Individual counselling
  • Practical demonstrations
  • Personalised feedback
  • Problem-solving strategies
  • Motivational support
  • Interactive activities
  • Peer group discussions
  • Reinforcement of behavioural changes The six HBM constructs will guide the educational content.
Comportamentale: Pharmacist-Led HBM-Based Educational Intervention

Participants in the intervention group will receive routine care together with structured pharmacist-led educational sessions based on the HBM.

The educational intervention will be conducted face-to-face during scheduled outpatient appointments in the designated counselling room of the Pulmonary Department.

The programme will be delivered from study months 4 to 9.

Educational sessions will include:

  • Printed educational materials
  • Lectures
  • Individual counselling
  • Practical demonstrations
  • Personalised feedback
  • Problem-solving strategies
  • Motivational support
  • Interactive activities
  • Peer group discussions
  • Reinforcement of behavioural changes The six HBM constructs will guide the educational content.
Nessun intervento: Standard Care

Participants in the control group will continue to receive routine/standard care provided by BCH.

They will not receive the additional structured pharmacist-led HBM-based educational intervention.

Both intervention and control participants will undergo the same baseline and post-intervention assessments.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Medication Adherence
Lasso di tempo: Baseline and 6 months after initiation of the educational intervention.
Change in medication adherence Measurement Tool 8-item Morisky Medication Adherence Scale (MMAS-8), prevalidated Arabic version Medication adherence will be assessed using MMAS-8 at baseline and following completion of the intervention.
Baseline and 6 months after initiation of the educational intervention.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life and Health Status
Lasso di tempo: Baseline and 6 months after initiation of the educational intervention.
Change in quality of life/health status Measurement Tool COPD Assessment Test (CAT), prevalidated Arabic version The CAT will be administered to participants in both groups at baseline and after completion of the intervention.
Baseline and 6 months after initiation of the educational intervention.
Direct Healthcare Costs
Lasso di tempo: Direct medical costs assessed during the pre-intervention baseline period and during the post-intervention follow-up period after completion of the six-month intervention.

Change in direct medical costs associated with COPD Direct medical cost data will be obtained from the clinical cost centre of BCH.

The costing analysis will include direct COPD-related healthcare resources such as:

  • Medications
  • Laboratory tests
  • Chest X-rays
  • Oxygen therapy Other direct medical resources documented within the approved data-collection instrument will be included as applicable.

Important Costing Specification The cost of delivering the educational intervention will not be included in the costing analysis.

The economic component of this study focuses on the direct cost of illness associated with COPD rather than the cost of implementing the educational intervention.
Direct medical costs assessed during the pre-intervention baseline period and during the post-intervention follow-up period after completion of the six-month intervention.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
HBM Constructs
Lasso di tempo: Baseline and 6 months after initiation of the educational intervention.

Changes in patients' health beliefs will be assessed using a structured, prevalidated Arabic HBM questionnaire.

The questionnaire assesses:

  • Perceived susceptibility
  • Perceived severity
  • Perceived benefits
  • Perceived barriers
  • Cues to action
  • Self-efficacy
Baseline and 6 months after initiation of the educational intervention.

Collaboratori e investigatori

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

Sponsor

Rabia Hussain

Collaboratori

Universiti Sains Malaysia

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 (Stimato)

1 settembre 2026

Completamento primario (Stimato)

30 agosto 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

7 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2026

Primo Inserito (Effettivo)

11 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • USM-DSAP-2026-002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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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