Impact of Adherence to Treatment in Asthma Control

NCT01455545 | Completed Results DMC

• 1 other identifier: HUGU ASMA 001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma.

Conditions

Asthma

Keywords

Asthma; Degree of Control; Exhaled Nitric Oxide; Asthma Control Test

Outcome Measures

Primary Outcomes (2)

• Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.

  The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence. Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma. To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers).

  4 weeks

• Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.

  Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19 . Good control if ACT score \> 19.

  4 weeks

Secondary Outcomes (10)

• Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.

  4 weeks

• Gender According to Level of Asthma Control.

  4 weeks

• Smoking Habit According to Level of Asthma Control.

  4 weeks

• Obesity According to Level of Asthma Control.

  4 weeks

• Rhinitis According to Level of Asthma Control.

  4 weeks

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ASTHMA will be categorized into two subgroups: a) 50 patients with good asthma control according to the Asthma Control Test (ACT) score; b) 50 patients with bad control asthma according to the ACT score.

You may qualify if:

• Patients with a diagnosis of asthma according to the Global Initiative for Asthma (GINA)guideline criteria .

You may not qualify if:

• Patients with a history of chronic obstructive pulmonary disease (COPD), residual pulmonary lesions or bronchiectasis seen on simple chest x-ray.
• Presence of another associated acute or chronic inflammatory disease.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha, 19002, Spain

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

This is an observational (cross-sectional )study, with the limitations and biases associated. Patients have not been randomized.

Results Point of Contact

• Title: Dr. Carlos Almonacid
• Organization: SESCAM - HOSPITAL UNIVERSITARIO DE GUADALAJARA

caralmsan@gmail.com

+34 655 53 44 75

Study Officials

• Carlos Almonacid Sanchez, Phd, MD

  Sociedad Española de Neumología y Cirugía Torácica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 20, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 28, 2013
• Results First Posted: August 28, 2013

Record last verified: 2013-06

Locations

ES (1)