Medication AdherenceECHO-COPDNCT07815353
ECHO-COPD: Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention Among Chronic Obstructive Pulmonary Disease Patients
A study testing Pharmacist-Led HBM-Based Educational Intervention in people with Medication Adherence and Quality of Life, run by Rabia Hussain at 1 site in Saudi Arabia.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease associated with substantial morbidity and mortality, impaired quality of life, and healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medication Adherence, Quality of Life, Cost
- What is being tested?
- Pharmacist-Led HBM-Based Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- Be adults aged 18-65 years.
- Be diagnosed with chronic obstructive pulmonary disease (COPD) stages I-III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- Have visited or been admitted for a COPD exacerbation and are receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia.
- Be Arabic-speaking and capable of understanding study instructions.
- Be willing and able to provide written informed consent.
Who cannot join
- Participants will be excluded if they:
- Are diagnosed with COPD stage IV.
- Have another significant pulmonary disease, including: Asthma, bronchiectasis, pneumonia, or cystic fibrosis.
- Have a serious systemic illness, severe comorbidity, or central organ dysfunction, including: Hepatic dysfunction, renal dysfunction, psychiatric impairment or sensory impairment.
- Are immunocompromised or receiving immunosuppressive treatment.
- Have psychological, sensory, or cognitive impairment that prevents meaningful participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Bander S Alshammeri
Buraidah, Al-Qassim Region, 52391
Bander S Alshammeri, MSc, +966509466669, bandershe3@gmail.com
About this study
Official title: Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention on Medication Adherence, Quality of Life, and Direct Costs in Patients With Chronic Obstructive Pulmonary Disease: A Quasi-Experimental Study
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. This study will use a quantitative, quasi-experimental pretest-posttest control-group design. 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 receive standard care without additional education. Baseline assessments will include medication adherence using the Morisky Medication Adherence Scale-8 (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.
Read the detailed description
The Health Belief Model (HBM) will guide the content and delivery of the pharmacist-led educational intervention. The intervention will address six core HBM constructs: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. The purpose of applying the HBM is to improve patients' understanding of chronic obstructive pulmonary disease (COPD) and promote positive behavioural changes, particularly improved medication adherence.
- Conditions
- Medication Adherence, Quality of Life, Cost, Health Belief Model, Chronic Obstructive Pulmonary Disease
- Being tested
- Pharmacist-Led HBM-Based Educational Intervention
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Health Belief Model, HBM, Medication adherence, Pharmacist-led education, Patient education, Quality of life, COPD Assessment Test, Direct medical costs, Self-management, Behaviour change, Saudi Arabia
- Medical subject headings
- Medication Adherence, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Led HBM-Based Educational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HBM-Based Educational Intervention | Experimental | 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. Receives: Behavioral: Pharmacist-Led HBM-Based Educational Intervention |
| Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Outcome Measure: Change in Medication Adherence Assessed by the Morisky Medication Adherence Scale-8.
Measurement Tool: Morisky Medication Adherence Scale-8 (MMAS-8), prevalidated Arabic version. The MMAS-8 is an 8-item self-reported measure of medication-taking behaviour, with a total score ranging from 0 to 8. Higher scores indicate better medication adherence, whereas lower scores indicate poorer adherence. Scores are commonly classified as low adherence (<6), medium adherence (6 to <8), and high adherence (8).
Measured: Baseline and 6 months after initiation of the educational intervention.
Secondary outcomes (2)
Quality of Life and Health Status
Outcome Measure: Change in Health Status Assessed by the COPD Assessment Test (CAT).
Description: The prevalidated Arabic COPD Assessment Test (CAT) will be used to assess health status in patients with chronic obstructive pulmonary disease. The CAT contains 8 items, each scored from 0 to 5, giving a total score range of 0-40. Higher scores indicate a greater impact of COPD on health status and therefore a worse outcome; lower scores indicate better health status.
Measured: Baseline and 6 months after initiation of the educational intervention.
Direct Healthcare Costs
Change in direct medical costs associated with COPD Direct healthcare cost data will be obtained from the clinical cost centre of Buraidah Central Hospital (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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabia Hussain
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Sponsor-investigator, Rabia Hussain, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815353
- Sponsor's protocol ID
- USM-DSAP-2026-002
- Acronym
- ECHO-COPD
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention on Medication Adherence, Quality of Life, and Direct Costs in Patients With Chronic Obstructive Pulmonary Disease: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07815353
- Acronym / sponsor ID
- ECHO-COPD / USM-DSAP-2026-002
- Conditions
- Medication Adherence, Quality of Life, Cost, Health Belief Model, Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Health Belief Model, HBM, Medication adherence, Pharmacist-led education, Patient education, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Rabia HussainUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This study will use a quantitative, quasi-experimental pretest-posttest control-group design. 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 receive standard care without additional education. Baseline assessments will include medication adherence using the Morisky Medication Adherence Scale-8 (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.
Detailed description
The Health Belief Model (HBM) will guide the content and delivery of the pharmacist-led educational intervention. The intervention will address six core HBM constructs: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. The purpose of applying the HBM is to improve patients' understanding of chronic obstructive pulmonary disease (COPD) and promote positive behavioural changes, particularly improved medication adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBM-Based Educational Intervention | Experimental | Behavioral: Pharmacist-Led HBM-Based Educational InterventionParticipants 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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be adults aged 18-65 years.
- Be diagnosed with chronic obstructive pulmonary disease (COPD) stages I-III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- Have visited or been admitted for a COPD exacerbation and are receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia.
- Be Arabic-speaking and capable of understanding study instructions.
- Be willing and able to provide written informed consent.
Key exclusion criteria (6 listed)
- Are diagnosed with COPD stage IV.
- Have another significant pulmonary disease, including: Asthma, bronchiectasis, pneumonia, or cystic fibrosis.
- Have a serious systemic illness, severe comorbidity, or central organ dysfunction, including: Hepatic dysfunction, renal dysfunction, psychiatric impairment or sensory impairment.
- Are immunocompromised or receiving immunosuppressive treatment.
- Have psychological, sensory, or cognitive impairment that prevents meaningful participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Led HBM-Based Educational InterventionParticipants 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. | Behavioural | HBM-Based Educational Intervention |
Primary outcome
Medication Adherence
Time frame: Baseline and 6 months after initiation of the educational intervention.
Outcome Measure: Change in Medication Adherence Assessed by the Morisky Medication Adherence Scale-8. Measurement Tool: Morisky Medication Adherence Scale-8 (MMAS-8), prevalidated Arabic version. The MMAS-8 is an 8-item self-reported measure of medication-taking behaviour, with a total score ranging from 0 to 8. Higher scores indicate better medication adherence, whereas lower scores indicate poorer adherence. Scores are commonly classified as low adherence (<6), medium adherence (6 to <8), and high adherence (8).
2 secondary outcomes
Quality of Life and Health Status
Time frame: Baseline and 6 months after initiation of the educational intervention.
Direct Healthcare Costs
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Led HBM-Based Educational Intervention in people with Medication Adherence and Quality of Life, run by Rabia Hussain at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bander S Alshammeri, MSc (+966509466669, bandershe3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: Baseline and 6 months after initiation of the educational intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.