Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05643183 |
| Other study ID # |
NL80559.058.22 |
| Secondary ID |
10390052010011 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 21, 2022 |
| Est. completion date |
June 14, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Leiden University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In the Netherlands, more than 600 thousand people have asthma. About half of these people
have insufficient asthma control. This has a negative effect on their health and use of care.
Insufficient knowledge about asthma and proper medication use, low self-confidence in
managing asthma, and low compliance contribute to this problem. AstmaKompas is an eHealth
application for asthma patients focused on self-monitoring and self-management. Astmakompas
also connects patients with their healthcare professionals, among other things by giving
healthcare professionals more insight into their patients' disease progression, enabling them
to provide timely(er) support. In this study, AstmaKompas will be deployed and evaluated in 2
hospitals. Through questionnaires and interviews, insight will be gained into the experiences
of patients and healthcare professionals with AstmaKompas. Potential effects on health
outcomes and healthcare utilization will also be identified.
Description:
Asthma is a major chronic disease that is estimated to affect approximately 262 million
people worldwide. Asthma control is often suboptimal, with approximately 50% of patients
having (partially) uncontrolled asthma. These patients have a higher risk of asthma
exacerbations, asthma-related hospitalization and emergency department visits, resulting in
high healthcare and societal costs. Poor asthma control is furthermore a major contributor to
impaired health-related quality of life. Although the literature shows promising results of
(digital) supported self-management interventions in improving asthma control and other
important health outcomes, relatively little is known about the cost-effectiveness of such
supported digital interventions delivered on a smartphone in comparison to usual care.
Furthermore, no cost-effectiveness research has been conducted in a secondary care.
The primary aim of the proposed pilot study is to investigate whether Astmakompas is
feasible, acceptable, easy and safe to use in a secondary care context for both patients and
healthcare professionals (HCPs). The secondary aim is to explore the potential effect of
Astmakompas on health and healthcare outcomes. Study design: A mixed-method study consisting
of a multi-center, single-arm, pre-post intervention study with a duration of 12 weeks. The
quantitative part consists of a survey providing insights on the feasibility, acceptability,
usability, safety, and preliminary effects of Astmakompas. The explanatory qualitative part
consist of semi structured focus groups for patients, and individual interviews for HCPs,
which will complement the quantitative results.
The researchers aim to recruit a total of 30 patients in two hospitals: 15 in the Amsterdam
UMC location AMC, and 15 in Medisch Spectrum Twente (MST). Inclusion criteria are 1) being
aged 18 years or older, 2) not having used Astmakompas before, 3) having a physician
diagnosis of asthma, 4) having uncontrolled asthma as defined by a score of 1.5 or higher on
the Asthma Control Questionnaire (ACQ), 5) being able to understand, read and speak the Dutch
language (i.e., based on self-report), and 6) having access to the Internet and a smartphone.
Exclusion criteria are having a respiratory disease other than asthma, or having a
non-reversible airway obstruction. Four involved HCPs (i.e., one pulmonologist and one
pulmonary nurse in each of the two participating hospitals) will be invited to participate in
the interviews.
Astmakompas is a CE-certified eHealth application for patients with asthma. The platform
consists of a patient app, a portal for HCPs, and a wireless spirometer connected to the
patient app. The patient app combines monitoring with self-management tools, and provides a
portal to present these data as well as to communicate with their HCP. The monitoring enables
patients to monitor their asthma control on a weekly basis using a standardized Patient
Reported Outcome Measure (PROM) questionnaire, and additionally with a spirometer that
assesses, amongst others, FEV1 and FVC. Patients' monitoring data is linked to their
personalized digital action plan, including self-management strategies and treatment
recommendations based on the latest international treatment guidelines. The action plan aims
to increase patients' awareness of their symptoms and/or the severity of their symptoms, as
well as their corresponding adverse effects. The action plan subsequently supports patients
to intervene in a more timely manner, thereby preventing worsening of symptoms. When
patients' monitoring results show a deterioration of asthma control, HCPs receive smart
notifications by means of algorithms. Patient data can thereby serve as direct input in the
consultations with the HCP, or they can proactively offer as-needed support. Patients are
able to ask non-critical asthma-related questions to their HCP through a chat function of the
application.
Primary study parameters include the Feasibility of Intervention Measure (FIM), the
Acceptability of Intervention Measure (AIM, only administered to HCPs), user patterns of
Astmakompas (e.g., number of logins), the Client Satisfaction Questionnaire-8 (CSQ-8, only
administered to patients), the System Usability Scale (SUS, administered to both HCPs and
patients), and adverse events (assessed in patients). Qualitative assessment in patients and
HCPs will give a more in-depth understanding of feasibility, acceptability, usability and
safety. Secondary study parameters, all assessed in patients, include asthma control
(assessed using the Asthma Control Questionnaire [ACQ] and the weekly monitoring
questionnaire that is part of Astmakompas), lung function as assessed by the spirometer, the
Respiratory Illness questionnaire-Monitoring 10 (RIQ-MON10), the EuroQol 5 dimensions 5
levels (EQ-5D-5L), the Perceived Control of Asthma Questionnaire (PCAQ), and items from the
iMTA Productivity Cost Questionnaire (iPCQ) and iMTA Medical Consumption Questionnaire
(iMCQ). Additionally, qualitative assessment in patients and HCPs will give a more in-depth
understanding of direct and indirect costs.
Regarding time investment, all participating asthma patients will be asked to complete a
questionnaire at baseline, taking approximately 15-20 minutes, and at post-intervention
(i.e., 12 weeks after baseline), taking approximately 25 minutes. Furthermore, part of the
Astmakompas intervention is completing a weekly questionnaire taking approximately 2-3
minutes to complete, and weekly spirometer assessments (i.e., approximately 1-5 minutes
each). In addition, a subsample of patients (n = 8 to 12) will participate in an online focus
group interview lasting approximately 90 minutes, which will be reimbursed with a gift
voucher of 25 euro. In line with the experiences of two previous small pilot studies, the
researchers do not expect any health risks to be associated with the use of Astmakompas.
Potential benefits include increased asthma control and self-management of the disease, as
well as more efficient care by means of among others increased access to medical staff.
Hence, the potential benefits are expected to outweigh the burden of the study. The
participating four HCPs will participate in an individual interview lasting 60 minutes, which
will be reimbursed with a gift voucher of 100 euro
