Pulmonology · Medical Literature
Pharmacist-led educational intervention to improve knowledge, medication adherence, and asthma control among asthma patients at Ayder Comprehensive Specialized Hospital: A protocol for randomized controlled trial.
Abstract
To evaluate the effect of a pharmacist‑led educational intervention on medication knowledge, adherence, and asthma control among adult asthma patients at Ayder Comprehensive Specialized Hospital, Ethiopia. A single‑blind, parallel‑group randomized controlled trial will be conducted. All eligible adult asthma patients on active follow‑up at the chest clinic of Ayder Comprehensive Specialized Hospital will be included. Participants will be randomly assigned via a computer‑generated sequence to an intervention group (structured pharmacist‑led education using teach‑back, illustrated pamphlets, a follow‑up phone call and SMS) or a control group (routine care). Outcome assessors will be blinded to group allocation. Outcomes will be measured at baseline and after three months, including medication adherence (GMAS), asthma control (ACT), medication knowledge, correct inhaler technique, and domain‑specific adherence barriers. Data will be analyzed using intention‑to‑treat with multivariable binary logistic regression, chi‑square tests, independent T-test, McNemar test, Mann‑Whitney U test, and Fisher's exact test where appropriate. Subgroup analyses will be performed to explore whether the intervention effect differs across patient characteristics. A p‑value < 0.05 will be considered statistically significant, with 95% confidence intervals reported. Pan African Clinical Trials Registry (PACTR202508565637179).
Clinical relevance
Does a pharmacist-led, multimodal educational intervention (teach-back, illustrated pamphlets, follow-up phone calls, and SMS) improve medication knowledge, adherence, and asthma control compared with routine care among adult asthma patients at a tertiary hospital in Ethiopia? __SNAPSHOT__ {"studyDesign":"Registered protocol for a single-blind, parallel-group randomized controlled trial (study not yet completed at time of publication)","setting":"Chest clinic, Ayder Comprehensive Specialized Hospital, Mekelle, Tigray Region, Ethiopia — a large tertiary academic referral center","sampleSize":"Not reported in the abstract; sample size calculation details not provided in the available text","population":"Adult patients with a confirmed asthma diagnosis on active follow-up at the chest clinic; specific inclusion and exclusion criteria not detailed in the abstract","intervention":"Structured pharmacist-led educational program using the teach-back method, illustrated educational pamphlets, follow-up telephone calls, and SMS messaging","comparator":"Routine clinical care (standard of care without structured pharmacist-led educational components)","primaryOutcome":"Not explicitly designated as a single primary endpoint in the abstract; pre-specified outcomes include medication adherence (assessed by GMAS — General Medication Adherence Scale), asthma control (assessed by ACT — Asthma Control Test), medication knowledge, correct inhaler technique, and domain-specific adherence barriers","followUp":"3 months (outcomes measured at baseline and 3 months post-randomization)","fundingSource":"Not reported"}
Key findings
This publication is a trial protocol, not a completed study. No outcome data, effect sizes, p-values, confidence intervals, or NNT/NNH values are available. The abstract describes the planned analytic approach: intention-to-treat analysis using multivariable binary logistic regression, chi-square tests, independent t-tests, McNemar tests, and Mann–Whitney U tests, as appropriate for the scale and distribution of each outcome. No interim or final results are reported. Any numerical findings attributed to this study at this stage would be fabricated and are therefore not reported here.
Practice implications
This is a pre-results protocol paper; no clinical inferences about effectiveness can be drawn at this time. The study addresses a clinically meaningful gap: pharmacist-delivered structured education for asthma patients in a resource-limited, sub-Saharan African tertiary setting is understudied, and existing evidence from higher-income settings suggests benefit in adherence and symptom control. The multimodal design (teach-back, pamphlets, phone/SMS follow-up) reflects best-practice behavior-change principles and is appropriate for the setting. The single-blind design (outcome assessors blinded, participants not blinded) is an acceptable and pragmatic approach for an educational intervention. Important unanswered questions include whether educational gains translate to sustained asthma control, what sample size was calculated and on what assumptions, and whether findings will be generalizable beyond this single Ethiopian tertiary center. Clinicians should not change practice based on this publication alone. NOTE: Only the abstract was available for review; full protocol details (eligibility criteria, sample size calculation, randomization and allocation concealment procedures, planned subgroup analyses, and ethical registration details) were not assessable. __LIMITATIONS__ [object Object] __BOTTOM_LINE_CATEGORY__ not_ready_for_clinical_application __BOTTOM_LINE__ This is a trial protocol for a single-blind RCT evaluating pharmacist-led asthma education at a tertiary Ethiopian hospital; no efficacy data are yet available. The study addresses a clinically important and understudied question in a resource-limited setting, using validated adherence and control instruments with a rigorous intention-to-treat analytical framework. Clinicians should monitor this trial for results before considering any practice modification based on this work.