Asthma, Allergic Clinical Trial
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]
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.
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
1. Therapy related factors
2. Patient related factors
3. Provider related factors
4. Disease related factors
5. 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.
;
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