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

NCT04479930 | Completed Phase 2

• 1 other identifier: CEU017
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Treatment Adherence

  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).

  10 months

Secondary Outcomes (3)

• Adherence to physical activity

  10 months

• Self-reported Quality of Life: EuroQOL-5D

  10 months

• Exercise Capacity

  10 months

Study Arms (2)

HappyAir Group

EXPERIMENTAL

The HappyAir app comprises two main parts: an educational program providing patients useful information and advice about their illness and data collection related to physical activity and disease.

Other: Pulmonary Care Web-Based App (HappyAir App)

Control group

NO INTERVENTION

The control group only underwent the scheduled check-ups

Interventions

Pulmonary Care Web-Based App (HappyAir App) OTHER

The HappyAir app reminded the HappyAir group daily to use the app, indicating that they record medication intake, daily exercise time (minutes), level of tiredness after the exercises (good, little tired, very tired, or exhausted), and daily mood (happy, little sad, sad, or very sad). The HappyAir integrated plan was designed as a model of a therapeutic program based on communication that introduced the figure of the therapeutic educator (physiotherapist or respiratory coach) in order to design interventions focused on the patients and their needs, with minimal intervention and presence, making the patients responsible for their self-care and management of their illness. Patient and educator shared responsibility.

HappyAir Group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• CEU San Pablo University: lead

Related Publications (1)

• Jimenez-Reguera B, Maroto Lopez E, Fitch S, Juarros L, Sanchez Cortes M, Rodriguez Hermosa JL, Calle Rubio M, Hernandez Criado MT, Lopez M, Angulo-Diaz-Parreno S, Martin-Pintado-Zugasti A, Vilaro J. Development and Preliminary Evaluation of the Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e18465. doi: 10.2196/18465.

  PMID: 32513646 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Begoña Jimenez Reguera, Msc

  CEU San Pablo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, CEU San Pablo University

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: December 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share