Chronic Obstructive Pulmonary DiseaseNCT05061810
The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease.
A study testing Smartphone application self-management programme in people with Chronic Obstructive Pulmonary Disease, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) has a significant impact on one's quality and quantity of life resulting in increased morbidity and mortality. In Ireland, COPD has the highest hospital admissions in comparison to other countries within the organisation for economic cooperation and development (OECD). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Smartphone application self-management programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIreland
- Study dates
- 13 Sep 2021to 28 Feb 2023
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18 years of age
- Confirmed COPD diagnosis defined as the presence of post- bronchodilator FEV1/FVC <0.70.
- COPD category GOLD A, B, C \& D.
- Those who are able to give informed consent
- Has a smart phone and is capable of using a smartphone app to input data?
- Good dexterity to use the spirometer and pulse oximeter
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease: A Randomised Trial
Chronic Obstructive Pulmonary Disease (COPD) has a significant impact on one's quality and quantity of life resulting in increased morbidity and mortality. In Ireland, COPD has the highest hospital admissions in comparison to other countries within the organisation for economic cooperation and development (OECD). There is a need to improve knowledge and self-management behaviour in order to improve recognition of early signs of an exacerbation thereby seeking early treatment from the general practitioner (GP) thus reducing hospital admissions among this cohort . There are limited studies pertaining to the use of a comprehensive self-management programme via a smartphone app for people with COPD on a longitudinal basis.The aim of this study is to investigate the effectiveness of a smartphone application self-management programme on clinical health outcomes in patients with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Smartphone application self-management programme
- 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.
Smartphone application self-management programmeBehavioural
The intervention in this trial is a self-management programme via a smartphone app. This self-management programme measures lung function (FEV1), oxygen saturation (SP02), dyspnoea score (m MRC) and step count. It also provides educational videos such as recognising symptoms of an exacerbation and physical activity. The smartphone app self-management programme will provide real time data monitoring resulting in baseline trends in patient's disease pattern. Additionally, it also provides subjective data that will allow the clinician to develop an understanding of the patient's quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Arm 1 | Experimental | Arm 1, group A will receive standard respiratory outpatient care such as routine virtual visits to the respiratory clinic at 6 and 12 months along with the use of a smartphone app self-management programme with follow up monthly phone calls. They will be asked to use the spirobank spirometer (measures lung function, FEVI), pulse oximeter (measures oxygen saturations, SP02) and input the dyspnoea score (m MRC), step count and view the educational videos on the app twice a week for twelve months. The smartphone app self-management programme will prompt the patient once a week to remind them to input their data. Furthermore, they will receive motivational messages weekly via the app. At the routine visits they will complete questionnaires on engagement, quality of life, m MRC scale and self-efficacy at these visits over the phone. They will inform the research team of self-reported GP visits or hospital admissions due to an exacerbation of COPD. Receives: Behavioral: Smartphone application self-management programme |
| Group B: Arm 2 | Experimental | Those allocated to the intervention groups B will receive standard respiratory outpatient care such as routine virtual visits at 6 and 12 months to the respiratory outpatient clinic along with the use of a smartphone app self-management programme. They will be asked to use the spirobank spirometer (measures lung function, FEV1), pulse oximeter (measures oxygen saturations, SP02) and input the dyspnoea score (m MRC), their step count and view the educational videos on the app twice a week for twelve months. The smartphone app self-management programme will prompt the patient once a week to remind them to input their data. Furthermore, they will receive motivational messages weekly via the app. At the routine visits they will complete questionnaires on engagement, quality of life, m MRC scale and self-efficacy at these visits over the phone. They will inform the research team of self-reported GP visits or hospital admissions due to an exacerbation of COPD. Receives: Behavioral: Smartphone application self-management programme |
| Group C: Arm 3 Control group | Active comparator | Participants in group C the control group will receive standard outpatient respiratory care which involves attending the routine visits as outlined above and informing the research team of an GP visits and or hospital admissions relating to an exacerbation of COPD. They will complete questionnaires on quality of life, m MRC scale and self-efficacy at these visits over the phone. Receives: Behavioral: Smartphone application self-management programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this trial will measure the number of COPD exacerbations reviewed in general practice and hospital setting
The number of COPD self-reported exacerbations reviewed by the GP versus the hospital. COPD exacerbations are defined as an acute event described by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medications (GOLD 2020). The primary outcome will be assessed by the research team at, three, six and twelve months using a patient self-reported approach.
Measured: 12 months
Secondary outcomes (4)
Engagement with technology
Engagement defined as a psychological state that embraces the dynamic and interactive relationship with a principal agent or object (e.g., a brand, product, or smartphone app) that satisfies the instrumental (utility) and pragmatic (emotional satisfaction) values of a consumer (Bowden 2009, Brodie et al. 2011). This outcome will be assessed by the research team at 3, 6 and 12 months using the, user engagement scale short form (O'Brien et al. 2018). This scale consists of 12 questions which the researcher will ask the participant to strongly agree-4/agree-3/disagree-2/strongly disagree-1. The overall engagement score will be calculated by adding all of the answers together and dividing by 12. The higher score indicates high levels of engagement.
Measured: 12 months
Physical activity levels
Defined as a planned, structured, repetitive and aims to improve or maintain one or more components of physical fitness (WHO 2018). This will be measured by viewing the step count activity patient reported exercise behaviour. This outcome will be measured by the research team at 6 and 12 months
Measured: 12 months
Health -related quality of life
- Health -related quality of life defined as "an individual's or group's perceived physical and mental health over time" (CDC 2000). This will be measured using the clinical COPD questionnaire. This questionnaire consists of 12 questions to which the participant can answer- never-0, hardly ever-1,a few times-2, several times-3, many times-4, a great many times-5, almost all of the time-6. Items are scored on a likert scale range from 0-60. The final score is the sum of all items divided by 10. Higher scores indicate a worse health status (poor quality of life).
Measured: 12 months
Self-efficacy
Self-efficacy is defined as one's own belief in their capability to complete tasks to reach their goals (Abedi et al. 2013). This will be measured using the self-efficacy to manage chronic disease scale is made up of 6-items ranging from1 (not at all confident)-10(totally confident). The score for each item is added up. Higher number indicates higher self-efficacy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start13 Sep 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single centre feasibility three-arm parallel randomised control trial (RCT) study. The trial consists of three groups which are, Group A, Arm 1 (standard respiratory outpatient care with a smartphone app self-management programme with follow up monthly phone calls), Group B, Arm 2 (standard respiratory outpatient care with a smartphone app and Group C, control group (standard respiratory outpatient care).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Tallaght University Hospital
- Responsible party
- Principal investigator, Lisa Glynn, University of Dublin, Trinity College
- Investigators
- Eddie Moloney, MD, Study chair, Tallaght University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061810
- Sponsor's protocol ID
- 00017
- Status last verified
- May 2023
- First submitted
- 15 Jul 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glynn L, Moloney E, Lane S, McNally E, Buckley C, McCann M, McCabe C. A Smartphone App Self-Management Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial of Clinical Outcomes. JMIR Mhealth Uhealth. 2025 Apr 23;13:e56318. doi: 10.2196/56318.
PubMed 40267465
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease: A Randomised Trial
- ClinicalTrials.gov ID
- NCT05061810
- Acronym / sponsor ID
- 00017
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Tallaght University Hospital
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 30 Sep 2021 (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.
Chronic Obstructive Pulmonary Disease (COPD) has a significant impact on one's quality and quantity of life resulting in increased morbidity and mortality. In Ireland, COPD has the highest hospital admissions in comparison to other countries within the organisation for economic cooperation and development (OECD). There is a need to improve knowledge and self-management behaviour in order to improve recognition of early signs of an exacerbation thereby seeking early treatment from the general practitioner (GP) thus reducing hospital admissions among this cohort . There are limited studies pertaining to the use of a comprehensive self-management programme via a smartphone app for people with COPD on a longitudinal basis.The aim of this study is to investigate the effectiveness of a smartphone application self-management programme on clinical health outcomes in patients with COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- A single centre feasibility three-arm parallel randomised control trial (RCT) study. The trial consists of three groups which are, Group A, Arm 1 (standard respiratory outpatient care with a smartphone app self-management programme with follow up monthly phone calls), Group B, Arm 2 (standard respiratory outpatient care with a smartphone app and Group C, control group (standard respiratory outpatient care).
| Arm | Type | Receives |
|---|---|---|
| Group A: Arm 1 | Experimental | Behavioral: Smartphone application self-management programmeArm 1, group A will receive standard respiratory outpatient care such as routine virtual visits to the respiratory clinic at 6 and 12 months along with the use of a smartphone app self-management programme with follow up monthly phone calls. They will be asked to use the spirobank spirometer (measures lung function, FEVI), pulse oximeter (measures oxygen saturations, SP02) and input the dyspnoea score (m MRC), step count and view the educational videos on the app twice a week for twelve months. The smartphone app self-management programme will prompt the patient once a week to remind them to input their data. Furthermore, they will receive motivational messages weekly via the app. At the routine visits they will complete questionnaires on engagement, quality of life, m MRC scale and self-efficacy at these visits over the phone. They will inform the research team of self-reported GP visits or hospital admissions due to an exacerbation of COPD. |
| Group B: Arm 2 | Experimental | Behavioral: Smartphone application self-management programmeThose allocated to the intervention groups B will receive standard respiratory outpatient care such as routine virtual visits at 6 and 12 months to the respiratory outpatient clinic along with the use of a smartphone app self-management programme. They will be asked to use the spirobank spirometer (measures lung function, FEV1), pulse oximeter (measures oxygen saturations, SP02) and input the dyspnoea score (m MRC), their step count and view the educational videos on the app twice a week for twelve months. The smartphone app self-management programme will prompt the patient once a week to remind them to input their data. Furthermore, they will receive motivational messages weekly via the app. At the routine visits they will complete questionnaires on engagement, quality of life, m MRC scale and self-efficacy at these visits over the phone. They will inform the research team of self-reported GP visits or hospital admissions due to an exacerbation of COPD. |
| Group C: Arm 3 Control group | Active comparator | Behavioral: Smartphone application self-management programmeParticipants in group C the control group will receive standard outpatient respiratory care which involves attending the routine visits as outlined above and informing the research team of an GP visits and or hospital admissions relating to an exacerbation of COPD. They will complete questionnaires on quality of life, m MRC scale and self-efficacy at these visits over the phone. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over the age of 18 years of age
- Confirmed COPD diagnosis defined as the presence of post- bronchodilator FEV1/FVC <0.70.
- COPD category GOLD A, B, C \& D.
- Those who are able to give informed consent
- Has a smart phone and is capable of using a smartphone app to input data?
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Smartphone application self-management programmeThe intervention in this trial is a self-management programme via a smartphone app. This self-management programme measures lung function (FEV1), oxygen saturation (SP02), dyspnoea score (m MRC) and step count. It also provides educational videos such as recognising symptoms of an exacerbation and physical activity. The smartphone app self-management programme will provide real time data monitoring resulting in baseline trends in patient's disease pattern. Additionally, it also provides subjective data that will allow the clinician to develop an understanding of the patient's quality of life. | Behavioural | Group A: Arm 1, Group B: Arm 2, Group C: Arm 3 Control group |
Primary outcome
The primary outcome of this trial will measure the number of COPD exacerbations reviewed in general practice and hospital setting
Time frame: 12 months
The number of COPD self-reported exacerbations reviewed by the GP versus the hospital. COPD exacerbations are defined as an acute event described by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medications (GOLD 2020). The primary outcome will be assessed by the research team at, three, six and twelve months using a patient self-reported approach.
4 secondary outcomes
Engagement with technology
Time frame: 12 months
Physical activity levels
Time frame: 12 months
Health -related quality of life
Time frame: 12 months
Self-efficacy
Time frame: 12 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 12 May 2023.
- Derived from this study: PubMed 40267465Glynn L, Moloney E, Lane S, McNally E, Buckley C, McCann M, McCabe C. A Smartphone App Self-Management Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial of Clinical Outcomes. JMIR Mhealth Uhealth. 2025 Apr 23;13:e56318. doi: 10.2196/56318.
- 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.
Eddie Moloney, MD study chair
Tallaght University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application self-management programme in people with Chronic Obstructive Pulmonary Disease, run by University of Dublin, Trinity College at 1 site in Ireland.
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 6 inclusion and 1 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The primary outcome of this trial will measure the number of COPD exacerbations reviewed in general practice and hospital setting (time frame: 12 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 NCT05061810, 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 12 May 2023.