Evaluation of a Novel eHealth Tool for Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease: Randomized Controlled Pilot and Feasibility Trial

Abstract

Background: There is a growing interest in eHealth solutions to enhance access to and use of pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD).

Objective: This study aims to evaluate the feasibility of a novel eHealth tool (Me&COPD) to support pulmonary rehabilitation concerning usability, exercise adherence, intensity, progression, and adverse events. Moreover, this study aims to evaluate clinical outcome measures to prepare for a future larger trial.

Methods: A multicenter, parallel-group randomized controlled pilot and feasibility trial was conducted in 6 primary health care centers. People with mild to severe COPD were recruited by physiotherapists at the included health care centers and randomized either to the intervention group with access to Me&COPD for 3 months or to the control group receiving usual care. The Me&COPD tool comprised audio-visual and written self-management strategies, including an individually tailored home-based exercise program and interaction with a physiotherapist. The exercise program was prescribed in a face-to-face meeting with a physiotherapist, and thereafter it was regularly reviewed and adjusted through the eHealth tool. The primary outcome, usability, was self-assessed at intervention completion in the intervention group and among participating physiotherapists (n=7) using the Swedish version of the Mobile Health App Usability Questionnaire (S-MAUQ). In addition, use data on exercise adherence, intensity, and progression and adverse events were exported from the eHealth tool. Clinical outcomes, assessed by blinded assessors at baseline and 3 months in the intervention and control groups, included exercise capacity, balance, physical activity level, COPD-related symptoms, and health-related quality of life. Descriptive statistics were used for analysis.

Results: In total, 22 participants (women: n=12, 55%), aged 72.3 (SD 8.4) years on average, were included in the intervention (n=15) and control (n=7) groups. The mean overall S-MAUQ scores out of 7 (highest possible usability) were 4.4 (SD 1.5) for participants and 4.5 (SD 1.2) for physiotherapists. Among the subscales, the highest score was assigned to usefulness among participants (S-MAUQ: mean 4.9, SD 1.3) and physiotherapists (S-MAUQ: mean 5.1, SD 1.7). No severe adverse events were registered, although exercise adherence, intensity, and progression evaluation were limited by incomplete exercise session registration. The test procedures and the clinical outcome measures used were found to be feasible for the participants and the assessors.

Conclusions: The novel eHealth tool, Me&COPD, seemed feasible in terms of safety and had acceptable usability among people with COPD and participating physiotherapists. Usability may be improved by better organization of the information and simplification of the exercise diary to enable collection of data on exercise adherence, intensity, and progression through the eHealth tool. The test procedures seemed feasible, although the recruitment process needs further consideration. The effectiveness of the intervention remains to be evaluated in a future larger trial.

Trial registration: ClinicalTrials.gov NCT05086341; https://clinicaltrials.gov/study/NCT05086341.

Keywords: COPD; RCT; chronic obstructive pulmonary disease; eHealth; eHealth tool; feasibility trial; pulmonary rehabilitation; randomized controlled trial; telerehabilitation; usability testing; user-centered design.

Figure 1

An overview of the content and features of the eHealth tool Me&COPD. COPD: chronic obstructive pulmonary disease.

Figure 2

CONSORT (Consolidated Standards of Reporting Trials) participant flow diagram.

Figure 3

Boxplots showing the intervention groups’ overall score on the Mobile Health App Usability Questionnaire and scores of the subscales ease of use and satisfaction, system information arrangement, and usefulness at the end of the trial. The boxplot whiskers indicate the highest and lowest values, respectively.

Figure 4

Boxplots showing the physiotherapists’ overall score on the Mobile Health App Usability Questionnaire and scores of the subscales ease of use and satisfaction, system information arrangement, and usefulness at the end of the trial. The boxplot whiskers indicate the highest and lowest values, respectively.