Digitally Supported Self-management Program for Patients With Asthma in Secondary Care: a Pilot Study

NCT05643183 | Completed DMC

• 2 other identifiers: NL80559.058.2210390052010011
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Asthma control; Uncontrolled asthma; Asthma; Self-management; Application; eHealth; mHealth

Outcome Measures

Primary Outcomes (4)

• Feasibility of Astmakompas according to patients and HCPs.

  Feasibility of the intervention at post-intervention according to patients and HCPs.

  After 12 weeks

• Acceptability of Astmakompas according to patients and HCPs.

  Acceptability of the intervention according to HCPs will be assessed at post-intervention using the 4-item Acceptability of Intervention Measure (i.e., AIM). Patients' satisfaction with Astmakompas at post-intervention will be assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8).

  After 12 weeks

• Usability of Astmakompas according to patients and HCPs.

  User-friendliness of Astmakompas will be assessed at post-intervention. In patients, the System Usability Scale (SUS) will be used to determine the user-friendliness of the Astmakompas intervention. In HCPs, the SUS will be used to determine the user-friendliness of the Astmakompas healthcare portal.

  After 12 weeks

• Safety of Astmakompas according to patients and HCPs.

  At post-intervention, an open-ended question will assess whether patients have experienced any negative effects due to their participation in Astmakompas.

  After 12 weeks

Secondary Outcomes (5)

• Asthma control in patients

  First day and after 12 weeks

• Rescue medication use in patients

  First day and after 12 weeks

• (Asthma related) Quality of Life (QoL) in patients

  First day and after 12 weeks

• Self-efficacy regarding perceived ability to manage and control asthma in patients

  First day and after 12 weeks

• (In)direct costs by/in patients

  First day and after 12 weeks

Study Arms (1)

Patients receiving Astmakompas

EXPERIMENTAL

30 patients from two hospital sites (AMC and MST)

Other: Astmakompas

Interventions

Astmakompas OTHER

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.

Patients receiving Astmakompas

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ACQ \[19\] Being able to understand, read and speak the Dutch language (i.e., based on self-report) Having access to the Internet and a smartphone

You may not qualify if:

• Having a respiratory disease other than asthma Having a non-reversible airway obstruction

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jiska Aardoom, Dr.

  Leiden University Medical Center (LUMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 8, 2022
• Study Start: November 21, 2022
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)