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Completed

NCT Number: NCT04479930

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

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.

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Key information

Conditions

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

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Treatment Adherence

    Time frame: 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 outcomes

  1. Adherence to physical activity

    Time frame: 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).

  2. Self-reported Quality of Life: EuroQOL-5D

    Time frame: 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

  3. Exercise Capacity

    Time frame: 10 months

    Exercise capacity was measured with the 6-Minute Walk Test (6MWT)

Sponsors and collaborators

Lead sponsor

CEU San Pablo University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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