Evaluating the Feasibility of a Mobile Self-management Application for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Rijnstate Hospital

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 Mobile self-management application for COPD  
 
 
 
 
 
 
 
 
Research Protocol  
 
Evaluating the feasibility of a mobile self-management application for patients with 
Chronic Obstructive Pulmonary Disease (COPD) 
 
Protocol ID 
 
Title 
Evaluating the feasibility of a mobile self-
management application for patients with Chronic 
Obstructive Pulmonary Disease (COPD) 
Version 
3 
Date 
19-11-2018 
Principal investigator 
Prof. dr. W.H. van Harten 
Coordinating investigator/project leader 
Laura Kooij, MSc 
Sponsor (in Dutch: verrichter/opdrachtgever) 
Rijnstate hospital 
Subsiding party 
NA 
Independent expert(s) 
 
Laboratory sites 
NA 
Pharmacy 
NA 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. 
INTRODUCTION ........................................................................................................................... 5 
2. 
OBJECTIVES ................................................................................................................................. 6 
3. 
STUDY DESIGN ............................................................................................................................ 6 
4. 
STUDY POPULATION .................................................................................................................. 6 
4.1 
Population (base) ..................................................................................................................... 6 
4.2 
Inclusion criteria ...................................................................................................................... 6 
4.3 
Exclusion criteria ..................................................................................................................... 7 
4.4 
Sample size calculation ........................................................................................................... 7 
5. 
TREATMENT OF SUBJECTS ....................................................................................................... 7 
5.1 
Investigational product/treatment ............................................................................................ 7 
5.2 
Use of co-intervention (if applicable) ...................................................................................... 8 
5.3 
Escape medication (if applicable) ........................................................................................... 8 
6. 
INVESTIGATIONAL PRODUCT ................................................................................................. 8 
7. 
NON-INVESTIGATIONAL PRODUCT ....................................................................................... 8 
8. 
METHODS ...................................................................................................................................... 8 
8.1 
Study parameters/endpoints..................................................................................................... 8 
8.1.1 
Main study parameter ...................................................................................................... 8 
8.1.2 
Secondary study parameters/endpoints (if applicable) .................................................... 9 
8.1.3 
Other study parameters (if applicable) .......................................................................... 10 
8.2 
Randomisation, blinding and treatment allocation ................................................................ 10 
8.3 
Study procedures ................................................................................................................... 10 
8.3.1 
Usability testing ............................................................................................................. 10 
8.4 
Withdrawal of individual subjects ......................................................................................... 11 
8.4.1 
Specific criteria for withdrawal (if applicable) .............................................................. 11 
8.5 
Replacement of individual subjects after withdrawal ............................................................ 11 
8.6 
Follow-up of subjects withdrawn from treatment ................................................................. 11 
8.7 
Premature termination of the study ....................................................................................... 11 
9. 
SAFETY REPORTING ................................................................................................................ 12 
10. 
STATISTICAL ANALYSIS ..................................................................................................... 12 
10.1 
Primary study parameter(s) ................................................................................................... 12 
10.2 
Secondary study parameter(s) ............................................................................................... 12 
10.3 
Other study parameters .......................................................................................................... 12 
10.4 
Interim analysis (if applicable) .............................................................................................. 12 
11. 
ETHICAL CONSIDERATIONS .............................................................................................. 12 
11.1 
Regulation statement ............................................................................................................. 12 
11.2 
Recruitment and consent ....................................................................................................... 13 
11.3 
Objection by minors or incapacitated subjects (if applicable)............................................... 13 
11.4 
Benefits and risks assessment, group relatedness .................................................................. 13 
11.5 
Compensation for injury ........................................................................................................ 13 
11.6 
Incentives (if applicable) ....................................................................................................... 13 
12. 
ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION .............................. 13 

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12.1 
Handling and storage of data and documents ........................................................................ 13 
12.2 
Monitoring and Quality Assurance ....................................................................................... 13 
12.3 
Amendments .......................................................................................................................... 13 
12.4 
Annual progress report .......................................................................................................... 14 
12.5 
End of study report ................................................................................................................ 14 
12.6 
Public disclosure and publication policy ............................................................................... 14 
13. 
STRUCTURED RISK ANALYSIS .......................................................................................... 14 
14. 
REFERENCES .......................................................................................................................... 15 

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LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS  
 
CCMO Central Committee on Research Involving Human Subjects; in Dutch: Centrale Commissie 
Mensgebonden Onderzoek 
COPD 
Chronic Obstructive Pulmonary Disease 
EMR 
Electronic Medical Record 
IT 
Information technology 
WMO 
Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch-wetenschappelijk 
Onderzoek met Mensen) 
 
 
 
 

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1. INTRODUCTION  
Chronic Obstructive Pulmonary Disease (COPD) affects over 250 million people worldwide [1], and 
almost 600.000 people in the Netherlands [2]. In 2020 it is expected to be the third leading cause of 
death [3]. COPD is “a common, preventable and treatable disease that is characterized by persistent 
respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually 
caused by significant exposure to noxious particles or gases” [3]. The most common symptoms are 
dyspnea, chronic coughing and sputum production [3, 4]. An acute worsening of the symptoms called 
an exacerbation [4, 5]. Exacerbations lead to additional care [3] and often to hospital admission [6], 
with considerable costs involved [7]. Multiple factors are associated with a higher risk for admission 
to the hospital for exacerbation including: previous admission, oral corticosteroids [8], dyspnea [8, 9], 
and increased PaCO2 [10] and older age [8, 9]. Although the results for age are contradictory [8]. 
 
Self-management interventions have the potential to reduce exacerbations and improve patients’ 
management over their health [11]. Behavior change is essential to achieve or improve self-
management [12, 13]. To enhance self-management patients should gain more knowledge and skills 
especially about their condition, medication, smoking cessation and when to ask for help [3]. COPD 
self-management interventions are defined as “structured but personalized and often multi-component, 
with goals of motivating, engaging and supporting the patients to positively adapt their health 
behavior(s) and develop skills to better manage their disease” [14]. Important features of COPD self-
management programs include: (1) smoking cessation, (2) recognition and treatment of exacerbation, 
(3) physical activity, (4) nutrition and (5) management of dyspnea. Additionally, relations with 
healthcare professionals, family and friends [14], breathing techniques, and stress management are 
important [12]. These interventions should be tailored to the specific situation of an individual patient, 
for which action-plans can be used [13]. 
 
The use of information technology in health care is promising [15] and can improve patients’ self-
management  [16]. In a recent Cochrane review it is reported that self-management interventions with 
a COPD exacerbation action plan can lead to a lower chance of respiratory-related hospitalizations 
[17]. However, only four studies were supported by information technology (IT), including integrated 
care programs using a web-based call center for patients to contact a nurse [18, 19] and e-learning for 
COPD management [20]. In these studies positive effects on readmissions were found [18, 20], 
knowledge and treatment adherence [19]. Tabak et al. [21] used a web-portal including a physical 
activity program, teleconsultation and self-management. Overall, in this study the use was good and 
patients were satisfied [21]. Technology can also be used to support patients at home. However, the 
added value of these intervention is not always clear, because these interventions are often part of a 
larger initiative to improve care [5].  
 

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Mobile health (mHealth), the use of mobile devices for example tablets and smartphone, is often used 
in healthcare for example for patient education, to enable health care professionals to monitor patients’ 
health [22] for communication and information exchange [23]. In mHealth interventions a number of 
features are implemented, some are more common for example questionnaires and education and 
others less common for example personalized feedback. More research on mobile applications is 
needed, especially because there is a lack of knowledge about the features provided in the for COPD 
patients [22]. 
 
In this study we will evaluate the feasibility of a mobile self-management application for patients with 
COPD who are at high risk for readmission.  
 
2. OBJECTIVES 
This study will evaluate the feasibility of a mobile self-management application for patients with 
COPD who are at high risk for readmission. The use (actual use according to log data) and overall 
satisfaction will be evaluated. Also the changes in self-management will be assessed, satisfaction 
about the different elements of the app andpreliminary evidence of the effects on hospital readmissions 
will be generated. 
 
3. STUDY DESIGN 
This is a one group, feasibility study  with assessments at baseline and after the intervention. 
 
4. STUDY POPULATION 
4.1 Population (base)  
We will include Dutch patients diagnosed with COPD. Patients will be recruited during their 
admission for an exacerbation in Rijnstate hospital in Arnhem. In total 113 patients were readmitted in 
the period october 2017 until march 2018. Assuming a participation rate of 40% we will be able to 
include 45 patients in a 6-month period. 
 
4.2 Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 
• 
diagnosed with COPD  
• 
Age > 18 years 
• 
admission to the hospital for exacerbation 
• 
at least one hospitalization for COPD exacerbation in the year preceding this study 
• 
having (access to) a tablet or smartphone 
• 
working internet connection 

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• 
proficiency in using a tablet or smartphone  
• 
ability to read and understand the Dutch language  
• 
signed informed consent 
 
Healthcare professionals: 
• 
pulmonologists, nurse practitioners and (specialized) nurses treating patients with COPD 
 
4.3 Exclusion criteria 
Patients who meet one of the following criteria will be excluded from the study: 
• 
No exacerbation of COPD 
• 
Comorbidities: cancer, severe cognitive or psychiatric comorbidities 
• 
no internet access 
• 
no access to a tablet or smartphone 
 
4.4 Sample size calculation 
NA 
 
5. TREATMENT OF SUBJECTS 
5.1 Investigational product/treatment 
During their admission in the hospital patients will be informed about the application and asked to 
download the app. A nurse will inform and support patients. The application provides patients with a 8 
week self-management program that consists of the following functionalities: 
• 
Lung exacerbation action plan (in Dutch: Longaanval actieplan) 
The lung exacerbation action plan (LAP) is provided by the Lung Foundation (‘Longfonds’in 
the Netherlands) and digitalized in the application. During admission in the hospital, patients 
will fill in the action plan together with a pulmonary nurse. The LAP helps patients to 
recognize change in their symptoms and guide them how to act upon these changes. The 
action plan consists of different categories and colors: ‘I am doing well today’ (green), ‘I  feel 
worse’ (yellow), “No improvement after 2 days” (orange) and ‘The situation is threatening’ 
(red). All levels include advices about their symptoms (for example dyspnea, production of 
sputum, coughing), medication, physical activity and nutrition. It is also possible to request a 
consult with a nurse after using the LAP. Patients can access and use the LAP at any time 
using the mobile application.  
 
 

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• 
Questionnaires 
In order to monitor patients’ health condition, we will ask them to fill in questionnaires during 
the 8 weeks. The following questionnaires are included in the self-management program: the 
Clinical COPD Questionnaire (CCQ) (weekly), the Hospital Anxiety and Depression Scale 
(HADS) (in week 1 and week 8) and weight (during admission and in week 8). The total 
score of the CCQ will also be accessible in the app. 
• 
Information and education 
During the 8 weeks, patients will receive daily information about COPD, exacerbations, 
medication, nutrition, physical activity and smoking (if relevant). Every week patients also 
receive a question to test their knowledge about the given information. 
• 
Video consultation 
Video consults will be planned in week 4 and week 8, with a pulmonary nurse. Patients can 
request a video consult. The pulmonary nurse will contact the patient between 13.00-13.30pm 
with a video consult, the same day or the next day. 
 
5.2 Use of co-intervention (if applicable) 
NA 
 
5.3 Escape medication (if applicable) 
NA 
 
6. INVESTIGATIONAL PRODUCT  
NA 
  
7. NON-INVESTIGATIONAL PRODUCT 
NA 
 
8. METHODS 
8.1 Study parameters/endpoints 
8.1.1 
Main study parameter 
The main study parameter is feasibility and will be evaluated by the components use and satisfaction. 
Feasibility will be determined considering outcomes of these outcomes and minimum levels for a 
successful program are provided below. 
 
 

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8.1.1.1 Expectations and experience – according to constructs of the UTAUT model 
Questionnaire that consist of questions covering constructs of the Unified Theory of Acceptance and 
Use of Technology (UTAUT) [24] model will be used to measure expectations and experiences of use 
of mobile application. The UTAUT consists of four constructs that influence behavioral intention and 
behavior: (1) performance expectancy, (2) effort expectancy, (3) social influence, (4) facilitating 
conditions. The items will be rated on a seven point scale. Results will be presented as mean and 
standard deviation (SD). Use (experience) is measured on a 7-point Likert scale.  
 
8.1.1.2 Actual use (log data) 
Use will be monitored with log data of the application. To evaluate feasibility we will also look at the 
log data for frequency and time of use of the total number of patients.  
 
8.1.1.3 Satisfaction 
All patients will be asked to complete questions about satisfaction with the self-management 
application, the information in the app and the user-friendliness of the app. This will be measured with 
a five-point likert scale. We will also ask patients about their overall satisfaction (on a scale of 1 – 10).  
8.1.2 
Secondary study parameters/endpoints (if applicable) 
8.1.2.1 Self-management 
The Partners in Health scale (PIH) will be used to measure self-management [25]. The PIH is a 12-
item scale and indicated good psychometric properties with reported internal consistency (Cronbach’s 
alpha =  0.82). In this study the Dutch version of the PIH will be used  consisting of 12-items and of 
two subscales: (1) knowledge and coping; (2) recognition and management of symptoms, adherence to 
treatment. The correlation between the two subscales is 0.43 [26]. The items will be rated on a 9-point 
Likert scale (0 – high self-management and 8 low self-management).  
 
8.1.2.2 Hospital readmissions 
A hospital readmissions (a readmission in the hospital for as least of 24 hours). The number of, 
including the reason for, hospital admissions will be monitored and this information will be obtained 
from the Electronic Medical Record (EMR).  
 
8.1.2.2 Emergency room visits 
The number of, including the reason for, emergency room visits per patient will be monitored and this 
information will be obtained from the Electronic Medical Record. 
 
 
 

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8.1.2.3 Satisfaction healthcare professionals 
After the last patient finishes the self-management program, health care professionals will also be 
asked to fill in a questionnaire to measure effects on: 
• 
Experiences the application  
• 
Experiences with monitoring the questionnaires 
• 
Satisfaction 
• 
Organizational advantages/disadvantages for example time investment, efficiency of work 
processes. 
8.1.3 
Other study parameters (if applicable) 
The patients’ age, marital status, education, experience with internet and internet use, 
tablet/smartphone skills and support (with tablet/smartphone use) will be measured using 
questionnaires. The GOLD stage, comorbidities, number of admissions and emergency room visits for 
exacerbations, reason for admission and emergency room visits we will extract from the EMR. We 
will obtain the results from the CCQ and HADS from the mobile COPD application. 
 
8.2 Randomisation, blinding and treatment allocation 
NA 
 
8.3 Study procedures  
This study consists of two stages: 1) usability testing and 2) feasibility study. 
8.3.1 
Usability testing 
Before the start of the feasibility study we will use usability testing techniques to receive feedback on 
a prototype of the application. We will use the ‘thinking aloud method’ for this usability testing. We 
will ask approximately 5-10 patients (until saturation is achieved) that are admitted in the hospital for 
a COPD exacerbation about their opinion regarding the app. Specifically we will give them some 
assignments for example “can you find the lung action plan and use it”, “can you fill in the CCQ”, 
“can you find and read the information about nutrition”. We will also ask patients about their opinion  
about the information, the length of the text, the readability, the frequency of new information in the 
app (daily),  the knowledge questions.  Based on this information we will adjust the application. 
Results from the usability testing will be used to improve the app. 
 
 
 
 
 

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8.4.2 Feasibility study 
Patients are informed by the study during a readmission (for exacerbation) in the hospital by a 
pulmonary nurse and they will also receive the patients information. One day (24 hours) before their 
discharge patients are asked for informed consent. The pulmonary nurse is also available to answer 
patients questions. The researcher (Laura Kooij) is available for the nurses to answer their questions. 
After signing the informed consent patients will be asked to fill in the baseline questionnaire and they 
are provided with information on how to download the app. If necessary, the nurse is available for 
support. The nurse and the patient will also fill in the lung exacerbation action plan and the nurse will 
tailored the app (according to the lung exacerbation action plan and smoking yes/no). The self-
management program consists of the lung exacerbation action plan, questionnaires, information and 
education, and contact (using video consult). Patients will be asked to fill in a questionnaire for study 
purposes at: 
• 
Baseline  
The questionnaire at baseline covers the aspects of self-management, expectations and socio-
demographics. 
• 
T1 - after  8 weeks, after finishing the self-management program  
The questionnaire at T1 covers aspects of self-management, experiences, use and satisfaction 
with the application and the received information. 
• 
T2 - after 5 months (3 months after finishing the self-management program) 
The questionnaire at T=2 covers aspects about self-management, experiences, satisfaction and 
use. 
 
8.4 Withdrawal of individual subjects 
Patients can leave the study at any time for any reason if they wish to do so without any consequences. 
The investigator can decide to withdraw a patient from the study for any medical reasons. 
8.4.1 
Specific criteria for withdrawal (if applicable) 
NA 
8.5 Replacement of individual subjects after withdrawal 
Subjects will not be replaced after withdrawal. 
8.6 Follow-up of subjects withdrawn from treatment 
NA 
8.7 Premature termination of the study 
NA 
 
 

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9. SAFETY REPORTING 
It is not expected that this study will jeopardize subject health or safety or will result in adverse 
effects. 
 
10. STATISTICAL ANALYSIS 
10.1 Primary study parameter(s) 
The main study parameter is feasibility and this will be evaluated in terms of use and satisfaction. We 
will use descriptives statistics to report on use (according to the log data) and satisfaction (mean and 
SD).  
  
10.2 Secondary study parameter(s)  
10.2.1 Self-management 
Changes in the parameter ‘self-management’ as measured with the PIH questionnaire will be assessed 
from baseline to 8 weeks and to 5 months and will be analyzed using a mixed model. 
 
10.2.2 Number of readmission 
The number of readmission, the clinical (>24 hours) and day admissions (<24 hours), emergency room 
visits and the reasons for the admission(s) and the visit(s) will be obtained from the EMR after 30 
days, 8 weeks, 5 months, 12 months and 24 months. The percentages of readmissions and emergency 
room visits will be compared with the numbers of the year preceding the study (from the hospital 
registry) by using descriptie statistics. 
 
10.3 Other study parameters 
Descriptive statistics (frequencies, percentages, means, standard deviations etc.) will be used to 
present sociodemographic and clinical variables as well as internet skills, tablet/smartphone skills. 
 
10.4 Interim analysis (if applicable) 
NA 
 
11. ETHICAL CONSIDERATIONS 
11.1 Regulation statement 
The handling of personal data will be in accordance with the Dutch Personal Data Protection Act (in 
Dutch: Algemene verordening gegevensbescherming (AVG)). 

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11.2 Recruitment and consent 
During hospitalization patients will be informed about the study by a pulmonary nurse. And they will 
be provided with the patient information regarding this study. Patients 2 to 3 days to think about 
participation in the study. During their last consult before discharge, 24 hours before discharge, 
patients are asked to sign informed consent. After that they will be informed about the application and 
get support downloading the application. 
 
11.3 Objection by minors or incapacitated subjects (if applicable) 
NA 
 
11.4 Benefits and risks assessment, group relatedness 
NA 
 
11.5 Compensation for injury 
NA 
 
11.6 Incentives (if applicable) 
NA 
 
12. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
12.1 Handling and storage of data and documents 
Data will be handled confidentially. A subject identification score list will be used to link the data to 
the subject. The key code will be safeguarded by the investigator (Laura Kooij) and will be saved on a 
computer in the work office at Rijnstate hospital. The data will be coded using numbers in order 
enrolment, 1 / 2 / 3 etc. The investigators Laura Kooij and the pulmonologists P.J.E. Vos, MD, PhD 
and A. Dijkstra, MD will have access to the source data. Data will be stored for at least 15 years in an 
office at Rijnstate hospital. 
 
12.2 Monitoring and Quality Assurance  
NA 
 
12.3 Amendments  
NA 
 

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12.4 Annual progress report 
NA 
 
12.5 End of study report 
The investigator will submit a final study report with the results of the study including any 
publications/abstracts of the study, to the Board of Directors and the Local Feasibility Committee of 
the hospital. 
 
12.6 Public disclosure and publication policy 
The investigators will publish the results of the study as soon as appropriate. 
 
13. STRUCTURED RISK ANALYSIS  
We used the risk analysis provided by Rijnstate. The use of this checklist resulted in the classification 
of the risk of this study as ‘little’. Because the estimated change for damage is ‘little’, the level of 
severity of the damage is ‘light’ and there is no vulnerable population included in the study. 
 
 
 

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