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| Name | Class |
|---|---|
| University of Basel | OTHER |
Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.
The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.
In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participants' smartphones. Patients were allowed to choose the inhalation times themselves. The reminder generated by the by the smartphone had to be quitted by the patients. Patients in the intervention group received support calls carried out by the pharmacist or trained study nurses, when the use of rescue medication doubled or when the medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback on their adherence at each clinical visit, especially for the results of the POEMS. |
|
| Control group | No Intervention | Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. Patients assigned to the control group did not receive any reminder or support regarding their adherence to inhaled medication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Monitoring with audio reminders and additional support | Device | Automated reminder: -Daily audio-reminder, generated by a smartphone. Support calls (only patients with Smartinhaler):
Feedback on adherence (only patients with POEMS): -At every clinical visit (after 2, 4 and 6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Next Asthma or COPD Exacerbation up to 182 Days | The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation". | 182 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Exacerbations. | Number of exacerbations during the study period. | 180 days |
| Number of Severe Exacerbations. | Exacerbations with the need for hospitalization. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Leuppi, Prof.MD PhD | 061 925 21 81 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital Baselland Liestal | Liestal | Basel-Landschaft | 4410 | Switzerland | ||
| Cantonal Hospital Baselland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31796013 | Derived | Gregoriano C, Dieterle T, Breitenstein AL, Durr S, Baum A, Giezendanner S, Maier S, Leuppi-Taegtmeyer A, Arnet I, Hersberger KE, Leuppi JD. Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial. Respir Res. 2019 Dec 3;20(1):273. doi: 10.1186/s12931-019-1219-3. | |
| 29061556 |
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Prior to randomization, all participants take part in a training course before the baseline visit. The goal of the training course is to provide refresher training on inhalation techniques in order to ensure that all participants are at the same level of disease knowledge and use their medication correctly.
Patients from several hospitals in the Basel region and patients treated by pulmonologists in private practice are screened for eligibility. In addition, advertisement is made using posters, flyers, as well as on ad-screens. Advertisement is also placed in local newspapers.
Enrolment started on January 2014 and will ended on September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS. |
| FG001 | Control Group | Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Next Asthma or COPD Exacerbation up to 182 Days | The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation". | Posted | Mean | Full Range | days to first exacerbation | 182 days |
|
Study duration of 6 months
All participants have the same minimal risk for adverse events not related to the study.
Patients were not exposed to any risk by participating in this study. Patients continued to use their prescribed medication as usual. Study participants were cared for by their usual physician(s). The diagnostic tests were carried out at low risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Claudia Gregoriano | Cantonal Hospital Baselland | +41619253765 | claudia.gregoriano@ksbl.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2017 | Feb 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| 180 days |
| Adherence to Puff Inhalers | Mean duration with Adherence to Puff Inhalers in the Target Range | 180 days |
| Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS | percentage of days with Adherence to Dry Powder Capsules. Taking adherence = [number of puffs inhaled during 24 hours / number of puffs prescribed during 24 hours) x 100. Correct taking adherence was considered when taking adherence was between 80-100%, based on previous studies.](streamdown:incomplete-link) | 180 days |
| Percentage of Days of Adherence | percentage of days of Adherence for puff inhalers (metered dose inhalers, Turbohaler, Discus, Ellipta) assessed by Smartinhalers. | 180 days |
| Percentage of Days With Timing Adherence | percentage of days with timing Adherence for dry powder capsules (Breezhaler, Handihaler), assessed by POEMS | 180 days |
| Percentage of Gaps in Puff Inhaler Use | Percentage of Gaps in Puff Inhaler Use Gaps = [number of days without inhalation during the whole study period / number of days in same time period] x 100. | 180 days |
| Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS. | Percentage of Gaps = [number of days without inhalation during the whole study period / number of days in same time period] | 180 days |
| Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period | Maximal gap length = number of consecutive days of the longest period of time without Inhalation during the investigated timeperiod.Assessed by Smartinhalers. | 180 days |
| Number of Days of the Longest Period of Time Without Inhalation. | Maximal gap length for dry powder capsules (Breezhaler, Handihaler), Assessed by POEMS = number of consecutive days of the longest period of time without inhalation. | 180 days |
| Score of the St. George Respiratory Questionnaire | Score of the St. George Respiratory Questionnaire. Quality of life was assessed using the St. George Respiratory Questionnaire. This is a questionnaire, which was developed for measuring impaired health and perceived well-being in patients with asthma and COPD. Each Subscore ranges from 0-100, higher scores indicate more limitations in one of the 4 domains. Subscore Symptoms (ranges from 0-100): higher scores indicate worse outcome Subscore Activity (ranges from 0-100): higher scores indicate worse outcome Subscore Impact (ranges from 0-100): higher scores indicate worse outcome Total Score (ranges from 0-100): higher scores indicate worse outcome. The total score is calculated as a weighted sum of the three subscores. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. | 180 days |
| Liestal |
| Basel-Landschaft |
| 4410 |
| Switzerland |
| Gregoriano C, Dieterle T, Durr S, Arnet I, Hersberger KE, Leuppi JD. Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 23;6(10):e204. doi: 10.2196/resprot.7522. |
| BG001 | Intervention Group | Patients were randomly assigned either to the intervention or control group. The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS. Smartinhaler/POEMS with audio reminders and additional support calls: Patients assigned to the intervention group will receive a Smartinhaler/POEMS, which will contain an audio reminder function. If the alarm function is on, a ring tone will be generated, after the time predesigned for inhalation. If the use of |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Control Group | Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. |
|
|
| Secondary | Number of Exacerbations. | Number of exacerbations during the study period. | Posted | Mean | Standard Deviation | number of exacerbations | 180 days |
|
|
|
| Secondary | Number of Severe Exacerbations. | Exacerbations with the need for hospitalization. | Posted | Mean | Standard Deviation | severe exacerbations | 180 days |
|
|
|
| Secondary | Adherence to Puff Inhalers | Mean duration with Adherence to Puff Inhalers in the Target Range | Posted | Mean | Standard Deviation | days in target range | 180 days |
|
|
|
| Secondary | Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS | percentage of days with Adherence to Dry Powder Capsules. Taking adherence = [number of puffs inhaled during 24 hours / number of puffs prescribed during 24 hours) x 100. Correct taking adherence was considered when taking adherence was between 80-100%, based on previous studies.](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | % of days in target range | 180 days |
|
|
|
| Secondary | Percentage of Days of Adherence | percentage of days of Adherence for puff inhalers (metered dose inhalers, Turbohaler, Discus, Ellipta) assessed by Smartinhalers. | Posted | Mean | Standard Deviation | % of days in target range | 180 days |
|
|
|
| Secondary | Percentage of Days With Timing Adherence | percentage of days with timing Adherence for dry powder capsules (Breezhaler, Handihaler), assessed by POEMS | Posted | Mean | Standard Deviation | % of days in target range | 180 days |
|
|
|
| Secondary | Percentage of Gaps in Puff Inhaler Use | Percentage of Gaps in Puff Inhaler Use Gaps = [number of days without inhalation during the whole study period / number of days in same time period] x 100. | Posted | Mean | Standard Deviation | % of gaps | 180 days |
|
|
|
| Secondary | Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS. | Percentage of Gaps = [number of days without inhalation during the whole study period / number of days in same time period] | Posted | Mean | Standard Deviation | % gaps | 180 days |
|
|
|
| Secondary | Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period | Maximal gap length = number of consecutive days of the longest period of time without Inhalation during the investigated timeperiod.Assessed by Smartinhalers. | Posted | Mean | Standard Deviation | days | 180 days |
|
|
|
| Secondary | Number of Days of the Longest Period of Time Without Inhalation. | Maximal gap length for dry powder capsules (Breezhaler, Handihaler), Assessed by POEMS = number of consecutive days of the longest period of time without inhalation. | Posted | Mean | Standard Deviation | days | 180 days |
|
|
|
| Secondary | Score of the St. George Respiratory Questionnaire | Score of the St. George Respiratory Questionnaire. Quality of life was assessed using the St. George Respiratory Questionnaire. This is a questionnaire, which was developed for measuring impaired health and perceived well-being in patients with asthma and COPD. Each Subscore ranges from 0-100, higher scores indicate more limitations in one of the 4 domains. Subscore Symptoms (ranges from 0-100): higher scores indicate worse outcome Subscore Activity (ranges from 0-100): higher scores indicate worse outcome Subscore Impact (ranges from 0-100): higher scores indicate worse outcome Total Score (ranges from 0-100): higher scores indicate worse outcome. The total score is calculated as a weighted sum of the three subscores. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. | Posted | Mean | Standard Deviation | score on a scale | 180 days |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | Control Group | Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. | 0 | 81 | 0 | 81 | 0 | 81 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Subscore Impact |
|
| Total Score |
|