Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations

NCT03449316 | Unknown Phase 4 DMC

• 1 other identifier: Protocol V3
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients. Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics. Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control. Ethics and dissemination: Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.

Conditions

Asthma; COPD

Keywords

Nebulizers and Vaporizers

Outcome Measures

Primary Outcomes (1)

• Adverse events

  This outcome will be quantifyed as "time to event" For Asthma, an event will be defined as increased respiratory clinical symptoms leading the patient to search for medical care, and resulting in any of the following: * Need for increased inhaled corticosteroid dose of at least 4x the regular dose * Need for increase of short-acting β2 agonists on a daily basis * Need for oral corticosteroids * Need for oral antibiotics * Hospitalization or Emergency Room (ER) visit with increased respiratory clinical symptoms. For COPD, an event will be defined as increased respiratory clinical symptoms inducing the patient to search for medical care, and resulting in any of the following: * Need for increase of long-acting β2 agonists on a daily basis * Need for oral corticosteroids * Need for oral antibiotics * Hospitalization or ER visit with increased respiratory clinical symptoms. Respiratory-related mortality and all-cause mortality will also be considered an adverse event.

  Evaluation at 12 months.

Secondary Outcomes (14)

• Clinical assessment

  Evaluation at 12 months

• Clinical assessment

  Evaluation at 12 months

• Clinical assessment

  Evaluation at 12 months

• Clinical assessment

  Evaluation at 12 months

• Quality of Life

  Evaluation at 12 months.

Study Arms (2)

Inhaler technique education

EXPERIMENTAL

This group will receive a structured and regular follow-up plan, with education on inhaler technique. Patients will be trained by a Family Doctor (the primary investigator) in terms of the inhaler technique using placebo devices similar to their own devices. A teach-to-goal approach will be used, repeating all correct steps as many times as needed in order for patients to perform them correctly at each evaluation. There will be visits at baseline and after 3, 6 and 12 months to assess outcomes. In each visit, and prior to the main intervention with the primary investigator, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator.

Behavioral: Inhaler technique education

Usual Care

NO INTERVENTION

This group will receive usual care from their own Family doctors, with no specific intervention. Each doctor will perform the necessary consultations according to his real life judgment. Besides this, this group will perform visits at baseline and after 3, 6 and 12 months to assess secondary outcomes. At each visit, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator. At any appointment, if the patient asks for or if the clinician decides to teach inhaler technique, that will be recorded. If any adjustments are made in drug classes or device types in every participants, this information will be recorded.

Interventions

Inhaler technique education BEHAVIORAL

Teaching of inhalers use with placebo devices in real training

Inhaler technique education

Eligibility Criteria

• Age: 65 Years - 130 Years
• Gender Eligibility Details: Elderly patients
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of COPD or Asthma, medicated with any kind of inhaler device (pressurized Metered Dose Inhaler (pMDI) with or without Spacer, Dry Powder Inhaler (DPI) or Soft Mist), aged ≥65 years and being a regular user of primary health care services (defined as having at least one consultation performed in the last two years with his/her own Family Doctor). In order to minimize diagnostic inaccuracy, Asthma and COPD diagnosis will be reviewed in every participant at baseline prior to enrolment and according to GINA and GOLD strategies.

You may not qualify if:

• Severe or acute illness (such as unstable cardiovascular status, unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax (within one month), recent thoracic, abdominal or eye surgery (within one month), acute nausea or vomiting, severe respiratory distress, dementia). Patients with intermittent asthma, as well as COPD patients with mild obstruction (GOLD class I) will be excluded, since these patients do not need to take inhaler medication on a daily basis, and tend to have a low frequency of disease exacerbations.

Sponsors & Collaborators

• Aveiro-Aradas Family Health Unit: lead

Related Publications (1)

• Maricoto T, Correia-de-Sousa J, Taborda-Barata L. Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations-a protocol for a single-blinded randomised controlled trial. BMJ Open. 2019 Jan 28;9(1):e022685. doi: 10.1136/bmjopen-2018-022685.

  PMID: 30696670 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding for the investigator that acess outcomes, that will not be involved in the intervention process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arms single blinded randomised controlled trial with a 1 year follow up

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 28, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 28, 2018

Record last verified: 2018-02