Asthma, AllergicNCT02990117
ICS Treatment Compliance of Asthma Patients
An observational study of Asthma, Allergic, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The introduction of inhaled medication as the primary treatment for asthma has led to substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still common and represents a considerable burden to patients and society [3, 4]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Allergic
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 20 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by investigator.
Who may be able to join
- Age ≥18 years old
- Living in the city same as the study site for a minimum period of two years
- Having China city residence medical insurance
- A history of at least one year of diagnosed asthma who should be on ICS or ICS/LABA inhalation treatment based on the criteria established by GINA.
- Patients On inhaled ICS or ICS/LABA treatment regard less of compliance level in the past 6 months
- Subjects who are willing to sign the informed consent.
Who cannot join
- Patients with active cardio or pulmonary disease such as bronchiectasis, COPD, cystic fibrosis, pulmonary tuberculosis, lung cancer, severe heart disease, etc.; other disorder such as HIV/AIDS, etc; or therapy that according to the physician could interfere with the aim of the study.
- Patients with mental or neurological diseases, or due to alcohol or other drug abuse, that may be incapable to understand and answer the question honestly, or unwilling to do so.
- Other conditions judged by investigator as unsuitable for this study
About this study
Official title: An In-depth Understanding of Determinants of Inhaled ICS Treatment Compliance of Asthma Patients: Generate Data From Structured Patient Interview & Cross Sectional Survey
The introduction of inhaled medication as the primary treatment for asthma has led to substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still common and represents a considerable burden to patients and society [3, 4]. An important reason for poor asthma control and consequently, increased healthcare expenditure is suboptimal adherence to the prescribed regimen [5-7].
Real-world market research study in hospitals across China reported that physicians perceived that only 23% of patients were fully compliant with their medication regime (77% non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal document]. The physician reported rate of full adherence was lower than the patient-reported rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of physicians) when treating an asthma.[8]
Read more
However
There is some evidence on the drivers of patient behaviour around low adherence but more depth research is needed
There is little evidence on variation of determinants of asthma inhaled treatment across different age of group
Our research aims to address above data gap Mean while this research can guide the development of new module on Red Scarf patient education program.
Read the detailed description
Study site(s) and number of subjects planned 8 level-3 hospitals across West China will participate in this study. 40 not well controlled asthma patients will participate the structured interview in stage1 and a total number of 300 patients are expected to participate cross sectional survey in stage 2.
Study period Estimated Time CSP approved Oct. 2016 First subject in Jan. 2017 Last subject in Aug. 2017 Database lock Dec. 2017 CSR Mar. 2017
Study design It is study including 2 stage, stage 1 of structured patient interview by investigators, Stage 2 of a multi-center, cross-sectional survey. 40 eligible asthma patients and/or their family supporter will be invited to participate in a one-time face to face structured interview in stage 1. Around 350 eligible asthma patients will be invited to participate in cross sectional survey which all Information and relevant data of their compliance to inhaled treatment therapy and response to measurement of compliance risk factors (determinants explored from stage 1) will be collected according to CRF, and inputted into an on-line electronic questionnaire data capture (EDC) system by site investigator(s), and valid data will be taken into statistical analyses.
Target subject population Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by investigator.
Objectives
Stage 1:
Primary Objective: Outcome Measure:
Non- Assumptive Deep Dive Qualitative Scoping to investigate determinants of poor adherence to ICS treatment through structured interview \& taskforce workshop Decide key measures for phase2 survey through steering committee group review. Categorized "risk factors" (patient behavior/belief, social status, medical care availability etc.) which very likely led to poor patient adherence on inhaled treatment adherence in partly or uncontrolled asthma patients
- Therapy related factors
- Patient related factors
- Provider related factors
- Disease related factors
- Practice and system related factors
Questionnaire with measures for asthma patient adherence determinants in survey on stage 2
Stage 2:
Primary Objective: Outcome Measure:
To investigate the relationship different risk factors (determinants explored from stage 1) and treatment adherence to further identify top 5 determinants most closely relative to inhalation treatment adherence
Decide key measures for phase2 survey through steering committee group review. Asthma patient compliance level on Inhaled treatment (ICS or ICS/LABA) by using validated MARS-A scale questionnaire below.
Risk factors (determinants explored from stage 1) measurements response from asthma patients
Secondary Objective: Outcome Measure :
Similar objectives on deferent life-stage group of asthma patients. Similar analysis by different life-stage group of patients (18- 30, 31-45,45-60, 60+)
Statistical methods
- All results will be described. In general, the descriptive statistics (number, mean, and median, standard deviation, minimum and maximum) will be presented for continuous variables. The frequency and percentage of subjects at each level or category will be presented for categorical variables. Where appropriate, 95% confidence intervals will be constructed.
- Risk factor analysis will be performed using univariate and multivariate regression model to explore the relationship between risk factors and the compliance level. In addition to multivariate analysis using all variables, a step-wise variable selection can be used. The level of both variable inclusion and exclusion will be set as 0.15. The important variable (s) can be forced in the model if applicable.
- Conditions
- Asthma, Allergic
- Being tested
- No Intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic patient | Asthma patients aged >18 in out-patient clinic of the first affiliated hospital of Xi'an Jiaotong university from November 2016 to January 2018 were investigated. A two-stage study was applied which was non-assumptive deep dive qualitative scoping to investigate the determinants of poor compliance in stage 1 asthma patients, and developed new questionnaire for cross sectional survey in stage 2 to obtain more accurate information about the critical issues on asthma management. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MARS-A scale
MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk factors (determinants explored from stage 1) measurements response from asthma patients
Measured: Mar.2017-Dec,2017
Secondary outcomes (1)
MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60
MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk facto rs measurements response from asthma patients
Measured: Mar.2017-Dec,2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start1 Nov 2016
- Primary completion20 Jan 2018
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, AllergicStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Li Manxiang, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Manxiang Li, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990117
- Sponsor's protocol ID
- ESR-16-12138
- Status last verified
- Aug 2019
- First submitted
- 21 Nov 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-depth Understanding of Determinants of Inhaled ICS Treatment Compliance of Asthma Patients: Generate Data From Structured Patient Interview & Cross Sectional Survey
- ClinicalTrials.gov ID
- NCT02990117
- Acronym / sponsor ID
- ESR-16-12138
- Conditions
- Asthma, Allergic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The introduction of inhaled medication as the primary treatment for asthma has led to substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still common and represents a considerable burden to patients and society [3, 4]. An important reason for poor asthma control and consequently, increased healthcare expenditure is suboptimal adherence to the prescribed regimen [5-7].
Real-world market research study in hospitals across China reported that physicians perceived that only 23% of patients were fully compliant with their medication regime (77% non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal document]. The physician reported rate of full adherence was lower than the patient-reported rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of physicians) when treating an asthma.[8]
However
There is some evidence on the drivers of patient behaviour around low adherence but more depth research is needed
There is little evidence on variation of determinants of asthma inhaled treatment across different age of group
Our research aims to address above data gap Mean while this research can guide the development of new module on Red Scarf patient education program.
Detailed description
Study site(s) and number of subjects planned 8 level-3 hospitals across West China will participate in this study. 40 not well controlled asthma patients will participate the structured interview in stage1 and a total number of 300 patients are expected to participate cross sectional survey in stage 2.
Study period Estimated Time CSP approved Oct. 2016 First subject in Jan. 2017 Last subject in Aug. 2017 Database lock Dec. 2017 CSR Mar. 2017
Study design It is study including 2 stage, stage 1 of structured patient interview by investigators, Stage 2 of a multi-center, cross-sectional survey. 40 eligible asthma patients and/or their family supporter will be invited to participate in a one-time face to face structured interview in stage 1. Around 350 eligible asthma patients will be invited to participate in cross sectional survey which all Information and relevant data of their compliance to inhaled treatment therapy and response to measurement of compliance risk factors (determinants explored from stage 1) will be collected according to CRF, and inputted into an on-line electronic questionnaire data capture (EDC) system by site investigator(s), and valid data will be taken into statistical analyses.
Target subject population Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by investigator.
Objectives
Stage 1:
Primary Objective: Outcome Measure:
Non- Assumptive Deep Dive Qualitative Scoping to investigate determinants of poor adherence to ICS treatment through structured interview \& taskforce workshop Decide key measures for phase2 survey through steering committee group review. Categorized "risk factors" (patient behavior/belief, social status, medical care availability etc.) which very likely led to poor patient adherence on inhaled treatment adherence in partly or uncontrolled asthma patients
- Therapy related factors
- Patient related factors
- Provider related factors
- Disease related factors
- Practice and system related factors
Questionnaire with measures for asthma patient adherence determinants in survey on stage 2
Stage 2:
Primary Objective: Outcome Measure:
To investigate the relationship different risk factors (determinants explored from stage 1) and treatment adherence to further identify top 5 determinants most closely relative to inhalation treatment adherence
Decide key measures for phase2 survey through steering committee group review. Asthma patient compliance level on Inhaled treatment (ICS or ICS/LABA) by using validated MARS-A scale questionnaire below.
Risk factors (determinants explored from stage 1) measurements response from asthma patients
Secondary Objective: Outcome Measure :
Similar objectives on deferent life-stage group of asthma patients. Similar analysis by different life-stage group of patients (18- 30, 31-45,45-60, 60+)
Statistical methods
- All results will be described. In general, the descriptive statistics (number, mean, and median, standard deviation, minimum and maximum) will be presented for continuous variables. The frequency and percentage of subjects at each level or category will be presented for categorical variables. Where appropriate, 95% confidence intervals will be constructed.
- Risk factor analysis will be performed using univariate and multivariate regression model to explore the relationship between risk factors and the compliance level. In addition to multivariate analysis using all variables, a step-wise variable selection can be used. The level of both variable inclusion and exclusion will be set as 0.15. The important variable (s) can be forced in the model if applicable.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatic patient | – | Other: No InterventionAsthma patients aged >18 in out-patient clinic of the first affiliated hospital of Xi'an Jiaotong university from November 2016 to January 2018 were investigated. A two-stage study was applied which was non-assumptive deep dive qualitative scoping to investigate the determinants of poor compliance in stage 1 asthma patients, and developed new questionnaire for cross sectional survey in stage 2 to obtain more accurate information about the critical issues on asthma management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by investigator.
Key inclusion criteria (6 listed)
- Age ≥18 years old
- Living in the city same as the study site for a minimum period of two years
- Having China city residence medical insurance
- A history of at least one year of diagnosed asthma who should be on ICS or ICS/LABA inhalation treatment based on the criteria established by GINA.
- Patients On inhaled ICS or ICS/LABA treatment regard less of compliance level in the past 6 months
Key exclusion criteria (3 listed)
- Patients with active cardio or pulmonary disease such as bronchiectasis, COPD, cystic fibrosis, pulmonary tuberculosis, lung cancer, severe heart disease, etc.; other disorder such as HIV/AIDS, etc; or therapy that according to the physician could interfere with the aim of the study.
- Patients with mental or neurological diseases, or due to alcohol or other drug abuse, that may be incapable to understand and answer the question honestly, or unwilling to do so.
- Other conditions judged by investigator as unsuitable for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Asthmatic patient |
Primary outcome
MARS-A scale
Time frame: Mar.2017-Dec,2017
MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk factors (determinants explored from stage 1) measurements response from asthma patients
1 secondary outcome
MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60
Time frame: Mar.2017-Dec,2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manxiang Li, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, Allergic, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MARS-A scale (time frame: Mar.2017-Dec,2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.