Clinical trial NCT05061810: The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Tallaght University Hospital
First posted: 2021-09-30
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome of this trial will measure the number of COPD exacerbations reviewed in general practice and hospital setting
timeFrame: 12 months
Secondary outcomes:
measure: Engagement with technology
timeFrame: 12 months
measure: Physical activity levels
timeFrame: 12 months
measure: Health -related quality of life
timeFrame: 12 months
measure: Self-efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Dublin 24
country: Ireland
facility: Tallaght University Hospital
Study officials:
affiliation: Tallaght University Hospital
name: Eddie Moloney, MD
role: STUDY_CHAIR
References: