The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease.

NCT05061810 | Completed DMC

• 1 other identifier: 00017
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Engagement with technology

  12 months

• Physical activity levels

  12 months

• Health -related quality of life

  12 months

• Self-efficacy

  12 months

Study Arms (3)

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.

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.

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.

Behavioral: Smartphone application self-management programme

Interventions

Smartphone application self-management programme BEHAVIORAL

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.

Group A: Arm 1; Group B: Arm 2; Group C: Arm 3 Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• n/a

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Tallaght University Hospital: collaborator

Study Sites (1)

Tallaght University Hospital

Dublin, W23P526, Ireland

Location

Related Publications (1)

• 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.

  PMID: 40267465 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Eddie Moloney, MD

  Tallaght University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Block randomisation sequence generation (allocation ratio of 1:1:1) to ensure equilibrium between the groups. Allocation concealment will be achieved through the use of an independent healthcare provider (HCP) who will retain the random allocation sequence
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Advanced Nurse Practitioner and PhD candidate

Model Details: 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).

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: September 30, 2021
• Study Start: September 13, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)