Digitally Supported Self-management Program for Patients With Asthma in Secondary Care: a Pilot Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): Astmakompas
Intervention type(s): Other
Intervention description(s): The Astmakompas 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. 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. When patients' monitoring results show a deterioration of asthma control, HCPs receive smart notifications. 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Asthma control; Uncontrolled asthma; Asthma; Self-management; Application; eHealth; mHealth