Chronic Obstructive Pulmonary DiseasePhase 2/3NCT04479930
Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2/3 study testing Pulmonary Care Web-Based App (HappyAir App) in people with Chronic Obstructive Pulmonary Disease, run by CEU San Pablo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary Care Web-Based App (HappyAir App)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to May 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
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
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
- Being tested
- Pulmonary Care Web-Based App (HappyAir App)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pulmonary Care Web-Based App (HappyAir App) |
| Control group | No intervention | The control group only underwent the scheduled check-ups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 months
Secondary outcomes (3)
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).
Measured: 10 months
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
Measured: 10 months
Exercise Capacity
Exercise capacity was measured with the 6-Minute Walk Test (6MWT)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study startDec 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bjreguera@ceu.es, CEU San Pablo University
- Investigators
- Begoña Jimenez Reguera, Msc, Principal investigator, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479930
- Sponsor's protocol ID
- CEU017
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32513646
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04479930
- Acronym / sponsor ID
- CEU017
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HappyAir Group | Experimental | Other: Pulmonary Care Web-Based App (HappyAir App)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. |
| Control group | No intervention | –The control group only underwent the scheduled check-ups |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Care Web-Based App (HappyAir App)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. | Other | HappyAir Group |
Primary outcome
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).
3 secondary outcomes
Adherence to physical activity
Time frame: 10 months
Self-reported Quality of Life: EuroQOL-5D
Time frame: 10 months
Exercise Capacity
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Derived from this study: PubMed 32513646Jimenez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Begoña Jimenez Reguera, Msc principal investigator
CEU San Pablo University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pulmonary Care Web-Based App (HappyAir App) in people with Chronic Obstructive Pulmonary Disease, run by CEU San Pablo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.