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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pulmonary Care Web-Based App (HappyAir App)
Sponsored by
CEU San Pablo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    HappyAir Group

    Control group

    Arm Description

    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.

    The control group only underwent the scheduled check-ups

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Adherence to physical activity
    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).
    Self-reported Quality of Life: EuroQOL-5D
    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
    Exercise capacity was measured with the 6-Minute Walk Test (6MWT)

    Full Information

    First Posted
    July 15, 2020
    Last Updated
    July 20, 2020
    Sponsor
    CEU San Pablo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04479930
    Brief Title
    Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CEU San Pablo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HappyAir Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group only underwent the scheduled check-ups
    Intervention Type
    Other
    Intervention Name(s)
    Pulmonary Care Web-Based App (HappyAir App)
    Intervention Description
    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 Outcome Measure Information:
    Title
    Treatment Adherence
    Description
    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).
    Time Frame
    10 months
    Secondary Outcome Measure Information:
    Title
    Adherence to physical activity
    Description
    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).
    Time Frame
    10 months
    Title
    Self-reported Quality of Life: EuroQOL-5D
    Description
    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
    Time Frame
    10 months
    Title
    Exercise Capacity
    Description
    Exercise capacity was measured with the 6-Minute Walk Test (6MWT)
    Time Frame
    10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Begoña Jimenez Reguera, Msc
    Organizational Affiliation
    CEU San Pablo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32513646
    Citation
    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.
    Results Reference
    derived

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

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