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Optimising inhaler education in patients with pulmonary disease


- candidate number22012
- NTR NumberNTR5187
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2015
- Secondary IDsNL52999.099.15 (ABR) 935 (RTPO Leeuwarden)
- Public TitleOptimising inhaler education in patients with pulmonary disease
- Scientific TitleInhaler instruction in patients with asthma or COPD: can it be improved?
- ACRONYM
- hypothesisInhaled mediation is the cornerstone of the treatment of patients with asthma or COPD. Adequate inhaler technique is crucial to maximise the benefits of inhaled medication treatment. However, inadequate inhaler technique and device mishandling is a common and widespread issue. Although device inhaler education has been shown to improve outcomes, research into the most optimal method or content of inhaler education is scarce. The newly developed inhaler specific patient instruction cards might be beneficial in optimising inhaler education in patients with obstructive pulmonary diseases resulting in beneficial effects in the management of patients using inhaled medication. The additional value of the use of these inhaler specific instruction cards in inhaler education in patients with asthma or COPD will be evaluated.
- Healt Condition(s) or Problem(s) studiedAsthma, COPD
- Inclusion criteria- age 18 years or older
- diagnosis asthma or COPD
- using maintenance medication for pulmonary disease
- signed written informed consent
- Exclusion criteria- received inhaler education in preceding 6 months
- difficulty with understanding the inhalation instruction (cognitive disorder or language problems)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-mei-2015
- planned closingdate1-apr-2016
- Target number of participants100
- InterventionsPatients in the usual care group will receive standard inhaler education from a COPD nurse. Instruction will be verbally provided as well as correct inhaler use will be demonstrated and practised.
Patient in the usual care + group will receive additional to the standard inhaler education a inhaler specific instruction card to support the inhaler education.
- Primary outcomeThe proportion of patients demonstrating adequate inhaler technique.
- Secondary outcomeThe number of errors while using the inhaler. Disease control, medication adherence, patient perceived side effects of inhaled cortocosteroids, patient satisfaction/experiences with the inhaler and instruction provided and satisfaction with the patient instruction card (in the usual care + group only).
- TimepointsThe study consists of two visits, respectively a baseline visit and a follow up visit (6 -8 weeks after baseline).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Siebrig Schokker
- CONTACT for SCIENTIFIC QUERIES Siebrig Schokker
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital Groningen
- Publicationsnot yet
- Brief summaryInhaled mediation is the cornerstone of the treatment of patients with asthma or COPD. Adequate inhaler technique is crucial to maximise the benefits of inhaled medication treatment. However, inadequate inhaler technique and device mishandling is a common and widespread issue. Although device inhaler education has been shown to improve outcomes, research into the most optimal method or content of inhaler education is scarce. The newly developed inhaler specific patient instruction cards might be beneficial in optimising inhaler education in patients with obstructive pulmonary diseases resulting in beneficial effects in the management of patients using inhaled medication. In this randomised controlled trial the additional value of these inhaler specific instruction cards will be assessed in optimising inhaler technique in patients with asthma or COPD. In total 100 patients with asthma or COPD visiting the outpatient department of Pulmonary Diseases of the Martini Hospital Groningen will be included in this study. The study consists of two visits, respectively a baseline visit and a follow up visit (6 to 8 weeks later). At baseline, patients will be randomised to either the usual care group (receiving standard inhaler education: verbally instruction and correct inhaler use will be demonstrated and practised) or the usual care + group (standard inhaler education with an additional inhaler specific instruction card to support the inhaler education. At both visits inhalation technique will be assessed, as well as questionnaires on disease control, medication adherence, patient perceived side effects, patient satisfaction/experiences with the inhaler and instruction provided and satisfaction with the instruction card will be filled out bij the patient. The results of this study will be valuable in optimising the use of inhaled medication and subsequently optimal care for patients with asthma or COPD.
- Main changes (audit trail)
- RECORD24-apr-2015 - 5-jul-2015


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