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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Smartphone application self-management programme

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin 24, Ireland, W23P526
    • Tallaght University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Arm 1; 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; 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.
Experimental: Group B: Arm 2; 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; 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.
Active Comparator: Group C: Arm 3 Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	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.	12 months

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Tallaght University Hospital
• Investigators: Study Chair: Eddie Moloney, MD, Tallaght University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: September 19, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 00017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No