JMIR Publications

ABSTRACT

Background:

Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF) is important to quickly trigger treatment and reduce respiratory damage. We hypothesized that using home-based and wearable connected devices (CDs) and educating patients to react in case of abnormal variations in a set of parameters would allow patients to detect and manage their PEx early with their care team.

Objective:

This qualitative study aims to assess the feasibility and appropriate conditions of a new PEx management process, from the users’ point of view, by analyzing the experience of patients and of CF center teams regarding the education program, the use of CDs, and the relationship between the patient and the care team during PEx management.

Methods:

We conducted a multi-center pilot study involving 36 CF patients aged ≥12 years. The intervention is divided into three phases. Phase 1 (3 months): Patients are equipped with CDs; their parameters are collected on three non-consecutive days each week. Phase 2: Development of a “REACT to PEx” educational program aimed at providing patients with a personalized action plan. Training of the physicians in the educational program. Physicians then determine the patients’ personalized alert thresholds by reviewing the data collected during phase 1 and their patient clinical history. Phase 3 (12 months): Patients are educated by the physician during a clinic visit and their action plan to react timely to their signs of PEx is defined. Education and action plans are revised during clinic visits. At the end of the project, the patients’ experience is collected during semi-structured interviews with a researcher as part of the qualitative study. The experience of CF teams is collected during focus groups using a semi-structured guide once all their patients have finished the study. The interviews and focus groups are recorded and transcribed verbatim to be analyzed. Data from educational sessions are collected throughout the educational program to be put into perspective with the learnings reported by patients. Analyses are led by two researchers using N’VIVO.

Results:

Out of the 36 patients included in phase 1, 27 were educated and entered phase 3. Qualitative analysis will provide a better understanding of users’ experience on the conditions of data collection, how useful CDs and alerts are to detect PEx, how useful the PEx action plan is to react to PEx, what patients learned about PEx management, the collaboration between patients and their care team, and the conditions for this PEx management to be sustainable in routine care.

Conclusions:

This study will open new perspectives for further research on the implementation of an optimal PEx care process in the organization of care teams in order to support patient self-management. Clinical Trial: N° ID RCB: 2017-A00723-50 ClinicalTrials.gov: NCT03304028