<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04479930</url>
  </required_header>
  <id_info>
    <org_study_id>CEU017</org_study_id>
    <nct_id>NCT04479930</nct_id>
  </id_info>
  <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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CEU San Pablo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CEU San Pablo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: This study aimed to assess the effects of an integrated care plan based on an&#xD;
      mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied&#xD;
      after pulmonary rehabilitation in COPD patients.&#xD;
&#xD;
      Methods: COPD patients from three hospitals were randomized to a control group or an&#xD;
      intervention group (HappyAir group). Patients from both groups received an 8-week program of&#xD;
      pulmonary rehabilitation and educational sessions about their illness. After completion of&#xD;
      the process, only the HappyAir group completed an integrated care plan for 10 months,&#xD;
      supervised by an mHealth system and therapeutic educator. The control group only underwent&#xD;
      the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy&#xD;
      adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to&#xD;
      physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary&#xD;
      Disease Assessment Test, St. George's Respiratory Questionnaire, and EuroQOL-5D), exercise&#xD;
      capacity (6-Minute Walk Test), and lung function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Adherence</measure>
    <time_frame>10 months</time_frame>
    <description>Adherence to the maintenance program was measured with the respiratory physiotherapy adherence self-report questionnaire (CAP PHYSIO).&#xD;
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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to physical activity</measure>
    <time_frame>10 months</time_frame>
    <description>Adherence to physical activity was measured with the therapeutic compliance questionnaire (Morisky-Green Test).&#xD;
It consists of a series of four contrast questions with a &quot;yes/no&quot; 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Quality of Life: EuroQOL-5D</measure>
    <time_frame>10 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Capacity</measure>
    <time_frame>10 months</time_frame>
    <description>Exercise capacity was measured with the 6-Minute Walk Test (6MWT)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>HappyAir Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group only underwent the scheduled check-ups</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulmonary Care Web-Based App (HappyAir App)</intervention_name>
    <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.</description>
    <arm_group_label>HappyAir Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patient.&#xD;
&#xD;
          -  Aged between 55 and 85 years.&#xD;
&#xD;
          -  Degree of severity II, III, or IV of the Global Initiative for Chronic Obstructive&#xD;
             Lung Disease (GOLD) scale.&#xD;
&#xD;
          -  Stable clinical situation (no exacerbations in the last 6 weeks).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable cardiovascular disease or muscular, osteoarticular, auditory, visual, or&#xD;
             central or peripheral nervous system impairment that prevents the performance of the&#xD;
             rehabilitation program or evaluation tests.&#xD;
&#xD;
          -  Cognitive impairment that makes it difficult to understand the education program and&#xD;
             manage the HappyAir system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Begoña Jimenez Reguera, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>CEU San Pablo University</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CEU San Pablo University</investigator_affiliation>
    <investigator_full_name>bjreguera@ceu.es</investigator_full_name>
    <investigator_title>Professor, CEU San Pablo University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04479930
org study id: CEU017
nct id: NCT04479930
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Treatment Adherence
time frame: 10 months
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).
measure: Adherence to physical activity
time frame: 10 months
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).
measure: Self-reported Quality of Life: EuroQOL-5D
time frame: 10 months
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
measure: Exercise Capacity
time frame: 10 months
description: Exercise capacity was measured with the 6-Minute Walk Test (6MWT)
arm group label: HappyAir Group
arm group type: Experimental
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 group label: Control group
arm group type: No Intervention
description: The control group only underwent the scheduled check-ups
intervention type: Other
intervention name: Pulmonary Care Web-Based App (HappyAir App)
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.
arm group label: HappyAir Group
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: Begoña Jimenez Reguera, Msc
role: Principal Investigator
affiliation: CEU San Pablo University
responsible party type: Principal Investigator
investigator affiliation: CEU San Pablo University
investigator full name: bjreguera@ceu.es
investigator title: Professor, CEU San Pablo University
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No