Trial Outcomes & Findings for Impact of Adherence to Treatment in Asthma Control (NCT NCT01455545)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

4 weeks

Results posted on

2013-08-28

Participant Flow

Dates of recruitment: Jan 2011 to Jan 2012. Location: medical clinic. Sampling method: Non-Probability Sample. Ages Eligible for Study: 16 yars to 80 years. Genders Eligible for Study: both.

Participant milestones

Participant milestones
Measure	Bad Control Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or \< 19 points.	Good Control Patient group with good control defined as participants with an Asthma Control Test (ACT)\> 19 points.
Overall Study STARTED	55	45
Overall Study COMPLETED	55	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Adherence to Treatment in Asthma Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asthmatic Patients n=100 Participants Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or \< 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score \> 19. In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA).
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age Continuous	45.25 years STANDARD_DEVIATION 15.89 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment Spain	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

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).

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.	34 units on a scale Interval 22.0 to 41.0	32 units on a scale Inter-Quartile Range 15 • Interval 22.5 to 43.0

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. adherence to inhalers >= 80%	33 participants	26 participants
Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. adherence to inhalers < 80%	22 participants	19 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: The same as primary outcome.

Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion). Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score \< or = 19 . Good control if ACT score \> 19.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.	27 units on a scale (parts per billion) Interval 17.0 to 45.0	28 units on a scale (parts per billion) Interval 18.5 to 40.0

SECONDARY outcome

Timeframe: 4 weeks

Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender. Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Gender According to Level of Asthma Control. male	16 participants	18 participants
Gender According to Level of Asthma Control. female	39 participants	27 participants

SECONDARY outcome

Timeframe: 4 weeks

Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit. Good control if ACT score \> 19. Bad control if ACT score \< or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Smoking Habit According to Level of Asthma Control. current smoker	7 participants	5 participants
Smoking Habit According to Level of Asthma Control. non smoker	25 participants	28 participants
Smoking Habit According to Level of Asthma Control. former smoker	23 participants	12 participants

SECONDARY outcome

Timeframe: 4 weeks

Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI \> 30 obesity. Asthma control was measured by Asthma Control test (ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19 .

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Obesity According to Level of Asthma Control. Normal	28 participants	25 participants
Obesity According to Level of Asthma Control. overweight - obesity	27 participants	20 participants

SECONDARY outcome

Timeframe: 4 weeks

Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis. Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19. Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Rhinitis According to Level of Asthma Control. yes	18 participants	21 participants
Rhinitis According to Level of Asthma Control. no	37 participants	24 participants

SECONDARY outcome

Timeframe: 4 weeks

Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Sinusitis According to Level of Asthma Control. no	54 participants	41 participants
Sinusitis According to Level of Asthma Control. yes	1 participants	4 participants

SECONDARY outcome

Timeframe: 4 weeks

Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux. Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=44 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Gastroesophageal Reflux According to Level of Asthma Control. yes	2 participants	0 participants
Gastroesophageal Reflux According to Level of Asthma Control. no	53 participants	45 participants

SECONDARY outcome

Timeframe: 4 weeks

Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders. Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Concomitant Psychiatric Disorders According to Level of Asthma Control. yes	7 participants	2 participants
Concomitant Psychiatric Disorders According to Level of Asthma Control. no	48 participants	43 participants

SECONDARY outcome

Timeframe: 4 months

Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry). Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Pulmonary Function Test (Spirometry) According to Level of Asthma Control.	84.23 percentage of the theoretical Standard Deviation 16.49	94.93 percentage of the theoretical Standard Deviation 18.04

SECONDARY outcome

Timeframe: 4 months

Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA). Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.

Outcome measures

Outcome measures
Measure	Bad Control n=55 Participants Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score \< or = 19 .	Good Control n=45 Participants Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score \> 19.
Asthma Severity According to Level of Asthma Control. mild-moderate asthma	24 participants	31 participants
Asthma Severity According to Level of Asthma Control. severe asthma	31 participants	14 participants

Adverse Events

Bad Control Asthmatic Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Good Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos Almonacid

SESCAM - HOSPITAL UNIVERSITARIO DE GUADALAJARA

Phone: +34 655 53 44 75

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place