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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061810
• Other study ID #: 00017
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Ireland	Tallaght University Hospital	Dublin 24

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Tallaght University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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