To investigate whether Astmakompas is feasible, acceptable, easy and safe to use in a secondary care context for both patients and healthcare professionals (HCPs), as well as to investigate its potential effects in improving health and healthcare…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters include the Feasibility of Intervention Measure (FIM),
the Acceptability of Intervention Measure (AIM, only administered in HCPs),
objective user patterns of Astmakompas, the Client Satisfaction Questionnaire-8
(CSQ-8, only administered in patients), the System Usability Scale (SUS,
administered in 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 of
Astmakompas.
Secondary outcome
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, illness-related quality of life as assessed by the
Respiratory Illness questionnaire-Monitoring 10 (RIQ-MON10), generic quality of
life as assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L), the Perceived
Control of Asthma Questionnaire (PCAQ), and direct and indirect costs as
assessed by 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.
Background summary
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 is been conducted in a secondary care. The proposed
pilot study is needed to establish whether Astmakompas is considered feasible,
acceptable, easy and safe to use in a secondary care context by both patients
and HCPs, as well as its potential of improving health and healthcare outcomes,
before commending a large-scaled cost-effectiveness study.
Study objective
To investigate whether Astmakompas is feasible, acceptable, easy and safe to
use in a secondary care context for both patients and healthcare professionals
(HCPs), as well as to investigate its potential effects in improving 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/ individual interviews for
patients, and individual interviews for HCPs, which will complement the
quantitative results.
Intervention
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. By means of the communication portal between patient and
HCPs, patients are able to ask non-critical asthma-related questions to their
HCP through a chat function of the application.
Study burden and risks
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 /
individual 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, we 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.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
• Being aged 18 years or older
• Not having used Astmakompas before
• Having a physician diagnosis of asthma
• Having uncontrolled asthma as defined by a score of >= 1.5 on the Asthma
Control Questionnaire
• Being able to understand, read and speak the Dutch language (i.e., based on
self-report)
• Having access to the Internet and a smartphone
Exclusion criteria
• Having a respiratory disease other than asthma
• Having a non-reversible airway obstruction
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL80559.058.22 |