Trial reportBMJ open2016
A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma.
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01529697 (Prospective Study of the Feedback From an Adherence Monitor on Asthma Control), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Interventions to improve adherence to inhaled steroids for asthma.The Cochrane database of systematic reviews · 2017Pooled it
- Interventions to improve inhaler technique for people with asthma.The Cochrane database of systematic reviews · 2017Pooled it
- A novel statistical method for assessing effective adherence to medication and calculating optimal drug dosages.PloS one · 2018Trial
- Trial
- Investigating Adherence to Asthma Management with an Electronic Monitoring System.Patient preference and adherence · 2025Article
- Flowrate Sensing and Measurement in Portable Smart Inhalers.Sensors (Basel, Switzerland) · 2024Review
- Clinical Impact of Electronic Monitoring Devices of Inhalers in Adults with Asthma or COPD: A Systematic Review and Meta-Analysis.Pharmaceuticals (Basel, Switzerland) · 2023Review
- The Design of a Persuasive Game to Motivate People with Asthma in Adherence to Their Maintenance Medication.Patient preference and adherence · 2023Article
- The Impact of Biofeedback on Self-Efficacy in Adults with Asthma: A Cross-Sectional Descriptive Survey.Patient preference and adherence · 2022Article
- Dry Powder Inhalers in the Digitalization Era: Current Status and Future Perspectives.Pharmaceutics · 2021Review
- Targeting patients with asthma for omalizumab therapy: choosing the right patient to get the best value for money.Therapeutic advances in chronic disease · 2017Review
- Predicting asthma exacerbations employing remotely monitored adherence.Healthcare technology letters · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 6 institutions in 2 countries.
Funding
Abstract
introductionIn clinical practice, it is difficult to distinguish between patients with refractory asthma from those with poorly controlled asthma, where symptoms persist due to poor adherence, inadequate inhaler technique or comorbid diseases. We designed an audio recording device which, when attached to an inhaler, objectively identifies the time and technique of inhaler use, thereby assessing both aspects of adherence. This study will test the hypothesis that feedback on these two aspects of adherence when passed on to patients improves adherence and helps clinicians distinguish refractory from difficult-to-control asthma.
methodsThis is a single, blind, prospective, randomised, clinical trial performed at 5 research centres. Patients with partially controlled or uncontrolled severe asthma who have also had at least one severe asthma exacerbation in the prior year are eligible to participate. The effect of two types of nurse-delivered education interventions to promote adherence and inhaler technique will be assessed. The active group will receive feedback on their inhaler technique and adherence from the new device over a 3-month period. The control group will also receive training in inhaler technique and strategies to promote adherence, but no feedback from the device. The primary outcome is the difference in actual adherence, a measure that incorporates time and technique of inhaler use between groups at the end of the third month. Secondary outcomes include the number of patients who remain refractory despite good adherence, and differences in the components of adherence after the intervention. Data will be analysed on an intention-to-treat and a per-protocol basis. The sample size is 220 subjects (110 in each group), and loss to follow-up is estimated at 10% which will allow results to show a 10% difference (0.8 power) in adherence between group means with a type I error probability of 0.05. TRIAL REGISTRATION NUMBER: NCT01529697; Pre-results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.