Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02386722
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2014-02-14
Brief Title:
Intervention to Improve Inhalative Adherence
Sponsor:
Cantonal Hosptal Baselland
Organization:
Cantonal Hosptal Baselland
Study Overview
Official Title:
Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asthma and chronic obstructive pulmonary disease COPD are common lung Despite the important progresses achieved in treatments the majority of affected patients suffer from severe symptoms and tend to be frequently hospitalised due to exacerbation Reasons for uncontrolled asthma and COPD are manifold but often a poor inhalation technique and a poor following of the prescribed treatment plan is observed which is called non-adherence
The primary aim of this study will therefore be to measure medication adherence in patients with chronic obstructive lung diseases and to investigate the impact of an audio reminder on disease outcomes and quality of life
The investigators hypotheses will be that an adherence reminder improve medication adherence and that a good medication adherence elongate the time to next exacerbation in patients with chronic obstructive lung diseases
A prospective single-blind randomized controlled study is planned where the investigators are going to analyse the adherence over a period of six months of in- and outpatients who have experienced at least one exacerbation during the last year The adherence of intervention- and control group will be measured by specific electronic data capture devices which can save each actuation with date and time Patients assigned to the intervention group will be reminded for the inhalation by an audio reminder and will receive support calls if medication will not be taken as prescribed or if rescue medication will be used too often In contrast the control group will not be reminded and will not receive any calls if do not comply with the prescribed medication schedule or if they use their rescue medication too frequently
During study period participants will be assessed every two months Each assessment will include spirometry measurement of diffusion capacity exhaled nitric oxide and carbon monoxide Moreover participants will demonstrate their inhalation techniques by using placebo devices and fill out questionnaires regarding quality of life
Statistical significance will be acquired if a p value of less than 005 is attained Time to next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard model Results will be reported as HR hazard ratio with corresponding 95 confidence interval CI and p-value
Time to next exacerbation is subject to the investigators power calculation A previous study has shown that 30 of COPD patients are readmitted again within six month because of an exacerbation The investigators expect that 12 of patients in the intervention group will have an exacerbation This corresponds to a hazard ratio of 036 Assuming a sample size of 70 subjects for each study group there is a power of 80 to detect a HR of 036 based on a one-tailed test Additional 14 subjects 7 for each study group have been added to account for drop outs Therefore 154 subjects will be investigated in this study
The primary aim of this study will therefore be to measure medication adherence in patients with chronic obstructive lung diseases and to investigate the impact of an audio reminder on disease outcomes and quality of life
The investigators hypotheses will be that an adherence reminder improve medication adherence and that a good medication adherence elongate the time to next exacerbation in patients with chronic obstructive lung diseases
A prospective single-blind randomized controlled study is planned where the investigators are going to analyse the adherence over a period of six months of in- and outpatients who have experienced at least one exacerbation during the last year The adherence of intervention- and control group will be measured by specific electronic data capture devices which can save each actuation with date and time Patients assigned to the intervention group will be reminded for the inhalation by an audio reminder and will receive support calls if medication will not be taken as prescribed or if rescue medication will be used too often In contrast the control group will not be reminded and will not receive any calls if do not comply with the prescribed medication schedule or if they use their rescue medication too frequently
During study period participants will be assessed every two months Each assessment will include spirometry measurement of diffusion capacity exhaled nitric oxide and carbon monoxide Moreover participants will demonstrate their inhalation techniques by using placebo devices and fill out questionnaires regarding quality of life
Statistical significance will be acquired if a p value of less than 005 is attained Time to next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard model Results will be reported as HR hazard ratio with corresponding 95 confidence interval CI and p-value
Time to next exacerbation is subject to the investigators power calculation A previous study has shown that 30 of COPD patients are readmitted again within six month because of an exacerbation The investigators expect that 12 of patients in the intervention group will have an exacerbation This corresponds to a hazard ratio of 036 Assuming a sample size of 70 subjects for each study group there is a power of 80 to detect a HR of 036 based on a one-tailed test Additional 14 subjects 7 for each study group have been added to account for drop outs Therefore 154 subjects will be investigated in this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None