Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04479930
• Lead Sponsor: CEU San Pablo University

Brief Summary

Objective: This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in COPD patients.

Methods: COPD patients from three hospitals were randomized to a control group or an intervention group (HappyAir group). Patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. After completion of the process, only the HappyAir group completed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The control group only underwent the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire, and EuroQOL-5D), exercise capacity (6-Minute Walk Test), and lung function.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2020-07
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• COPD patient.
• Aged between 55 and 85 years.
• Degree of severity II, III, or IV of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) scale.
• Stable clinical situation (no exacerbations in the last 6 weeks).

Exclusion Criteria

• Unstable cardiovascular disease or muscular, osteoarticular, auditory, visual, or central or peripheral nervous system impairment that prevents the performance of the rehabilitation program or evaluation tests.
• Cognitive impairment that makes it difficult to understand the education program and manage the HappyAir system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Adherence	10 months	Adherence to the maintenance program was measured with the respiratory physiotherapy adherence self-report questionnaire (CAP PHYSIO).; It consists of a total of 16 items, with a Likert scale to score each one, with 1 point as totally disagree and 4 points as totally agree. Three different dimensions of results are obtained: Total CAP, Perception and Adherence. The final rating scale is set to a range of minimum of 16 points (minimum adherence) to a maximum of 64 points (maximum adherence).

Secondary Outcome Measures

Name	Time	Method
Self-reported Quality of Life: EuroQOL-5D	10 months	Quality of life was measured with three different self-reported questionnaires, including the Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire and EuroQOL-5D
Exercise Capacity	10 months	Exercise capacity was measured with the 6-Minute Walk Test (6MWT)
Adherence to physical activity	10 months	Adherence to physical activity was measured with the therapeutic compliance questionnaire (Morisky-Green Test).; It consists of a series of four contrast questions with a "yes/no" dichotomous answer, which reflects the patient's behavior with respect to compliance. It results in a score ranging from 0 (High adherence) to 4 (Low adherence).