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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Medication Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the nature of the educational intervention, participants and the pharmacist delivering the intervention will be aware of group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Pharmacist-Led HBM-Based Educational Intervention (Behavioral)
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.
结局指标
主要结局
Medication Adherence
时间窗: 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).
次要结局
- Quality of Life and Health Status(Baseline and 6 months after initiation of the educational intervention.)
- Direct Healthcare Costs(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.)
研究者
Rabia Hussain
DR. Rabia Hussain, Principal Investigator
Universiti Sains Malaysia