Transitional Care Model Evaluation 2020
NCT04212962
CHF - Congestive Heart Failure, COPD
Princeton, New Jersey, United States
View Trial DetailsNCT Number: NCT06135324
INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims:
1. Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD). 2. Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs.
This study is active but is not currently recruiting participants.
60 year–90 year
All sexes
Observational
University of Alabama at Birmingham - Lung Health Center, Birmingham, Alabama, United States
To prescribe inhaled therapy for patients with COPD, health care professionals (HCPs) must make three decisions: short vs long-acting medication, medication class (beta2 agonists, muscarinic antagonists and/or corticosteroids) and delivery system.
At present, there is no guidance by national and international groups of experts on selecting the most appropriate delivery system for patients with COPD. On the other hand, there is a general belief among HCPs that there is no difference in efficacy among pressurized metered dose inhalers (pMDIs), slow mist inhalers (SMIs), dry powder inhalers (DPIs), and nebulizer delivery if the patient uses correct inhaler technique. Unfortunately, there is extensive evidence that patients with COPD exhibit numerous errors using hand-held devices. Experts have opined that HCPs should consider prescribing nebulizer medications for patients with COPD based on various factors or conditions, particularly cognitive impairment and problems with manual dexterity. However, there is little if any supportive evidence for these recommendations.
In stable out-patients with an established diagnosis of moderate to very severe COPD (pulmonary function tests within the last 12 months that demonstrate FEV1 < 60% Predicted required for screening purposes), we hypothesize the following:
The objectives of this study are:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion, average of 1 year by assessing cognitive levels using the Mini-Mental State Exam tool and Functional Dexterity Test for impaired manual dexterity function.
Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD.
Time frame: Through study completion, average of 1 year using a standardized check list for assessment of Inhaler Techniques using pMDI, SMI, and/or DPIs.
Assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
COPD Foundation
Other
Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)
Acronym: INHALE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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