A Pilot- and Feasibility Trial of the eHealth Tool My COPD for People With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— My COPD  

Official title:

A Randomized Controlled Pilot- and Feasibility Trial of the eHealth Tool My COPD, to Evaluate User Satisfaction, Reach and Safety in People With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086341
• Other study ID #: Feasibility My COPD
• Secondary ID: 2020-01957201904
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2022
• Source: Umeå University
• Contact: Karin Wadell, PhD
• Phone: +46 90 786 98 87
• Email: karin.wadell[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this multi-center, randomized controlled pilot- and feasibility trial is to evaluate the user satisfaction, reach and safety of My COPD, a novel eHealth tool for remote delivery of evidence-based treatment targeting people with chronic obstructive pulmonary disease (COPD). In addition, the investigators aim to collect and synthesize data on clinical outcome measures to inform the sample size estimation of a later, definitive trial.

Description:

Chronic obstructive pulmonary disease (COPD) is one of the most common non-communicable (chronic) diseases, leading to significant increased risk of morbidity and mortality. Pulmonary rehabilitation is a comprehensive intervention, including but not limited to physical exercise, education and behavioral change. Conclusive evidence supports the provision of pulmonary rehabilitation in adults with COPD, which benefits exercise tolerance, physical activity, health-related quality of life, health care use, and survival. However, access to pulmonary rehabilitation needs to be increased, which has recently been highlighted as a top priority by leading experts in the area.

To increase access to evidence-based treatment for people with COPD this research group has developed a novel eHealth tool, My COPD, in co-creation with intended end-users to meet requirements and needs of adults with COPD and health care providers. My COPD includes components to promote physical exercise, education and behavioral change, for example, information on disease management and treatment, symptom diary, an individualized physical exercise and activity plan, support from physiotherapist as well as self-management strategies. My COPD will be available on a nation-wide platform for internet-based support- and treatment programs that regional health care regions throughout Sweden offers.

The research aim of this trial is to explore the users' satisfaction, reach and safety of My COPD, and to collect and synthesize data on clinical outcome measures to inform the sample size estimation of a later definitive trial. For this purpose, the investigators will conduct a multi-center, parallel-group randomized controlled pilot- and feasibility trial, with usual care as comparison group (control), for the duration of 12 weeks. In total, 30 adults with stable COPD will be recruited from hospitals and primary care centers located in public health regions in central (Region Stockholm) and northern (Region Västerbotten) Sweden.

All participants will be invited to complete an initial screening and baseline assessment before the randomization and intervention commences. Descriptive baseline assessments that will be collected include assessment of pulmonary function (spirometry), while having usual bronchodilator therapy according to guidelines. Anthropometric data collected will include age, sex, height, weight, and body mass index. Further data that will be collected include information on smoking status, education, and co-morbidities and medications that may influence physical capacity or activity.

At completion of informed consent, enrolment and baseline assessment procedures, participants will be randomized to either the intervention group (My COPD) or control group (usual care). Randomization will be conducted using opaque envelopes, and administered by a researcher not involved in the assessment procedures, thus, ensuring concealed allocation. Participants will be randomized to the intervention (My COPD) and control group (usual care) group, using a 2:1 allocation ratio and stratified by sex and center.

Before and after the 12-week intervention assessments of exercise capacity, balance, level of physical activity, health related quality of life, COPD related symptoms, health economics will be conducted in all participants. During the intervention, data on exercise intensity, adverse events, adherence and progression will be collected from participants in the intervention group via My COPD. At intervention completion the user satisfaction of participants and health care professionals in the intervention group will be assessed. Participants in both groups will be asked to describe their COPD-related health care contacts during the study period. Physiotherapists, blinded to group allocation and previous test results, will conduct assessments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• a confirmed diagnosis of COPD

Exclusion Criteria:

• inability to read and understand Swedish

• severe comorbidity that can be considered as the main contributing factor for limitation in physical activity.

In case of an exacerbation, the participant has to wait six weeks from the start of pharmacological treatment before being eligible in the study.

Related Conditions & MeSH terms

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

Intervention

Device:
• My COPD
In addition to usual care, participants in the intervention group will initially meet with a physiotherapist to set up an individualized exercise program and physical activity plan. Participants will also receive a device instruction manual and a one hour of face-to-face training on how to use My COPD. The 12-week intervention is home-based, and self-managed with support from physiotherapist via My COPD. In addition to warm-up exercises, the exercise program comprises five exercises targeting major muscle groups, as well as, balance and aerobic exercise, to be conducted at least twice weekly. Via My COPD, the physiotherapists can follow activities and progress the exercise program, and the physiotherapist and the participants can contact each other. Throughout the intervention period, technical support will be available.

Locations

Country	Name	City	State
Sweden	Karolinska Intitutet	Stockholm
Sweden	Umeå university	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise intensity	The Borg CR-10, with a score ranging 0-10 (higher score indicating higher intensity)	During the 12-week intervention
Other	Adverse events	Frequency and severity	During the 12-week intervention
Other	Adherence	Frequency of completed exercise sessions/activities	During the 12-week intervention
Other	Progression of exercises	Frequency of completed exercise levels	During the 12-week intervention
Primary	User satisfaction	The mHealth App Usability Questionnaire (MAUQ) for patients, and health care staff, with score ranging 21-147 (higher score indicating better usability)	12-week follow-up (end of intervention)
Secondary	Physical capacity	The 6 minute walk test (6MWT) (distance in meters)	Baseline and 12-week follow-up
Secondary	Physical capacity	The 1 minute sit-to-stand test (count)	Baseline and 12-week follow-up
Secondary	Physical capacity	The Timed Up and Go (TUG) (time in minutes)	Baseline and 12-week follow-up
Secondary	Physical capacity	The Unsupported Upper Limb Exercise test (UULEX)(time in minutes)	Baseline and 12-week follow-up
Secondary	Level of physical activity	Accelerometer (Minimod, McRoberts®, NL) (steps, time in activity/inactivity)	Accelerometer wear (7 days prior to intervention commencement) and at 12-week follow-up
Secondary	Level of physical activity	Indicator questions on physical activity (time in hours)	Baseline and 12-week follow-up
Secondary	Health related quality of life (HrQoL)	The St Georges Respiratory Questionnaire (SGRQ), with score ranging from 0-100 (higher score indicating more limitation)	Baseline and 12-week follow-up
Secondary	COPD related symptoms	The Modified Medical Research Council dyspnea scale (mMRC), with score ranging 0-4 (higher score indicating more symptoms)	Baseline and 12-week follow-up.
Secondary	COPD related symptoms	The COPD Assessment test (CAT), with score ranging 0-40 (higher score indicating more symptoms)	Baseline and 12-week follow-up.
Secondary	Health economics	The EQ-5D to estimate change in quality-adjusted-life-years (QALYs), with score ranging 0-100 (higher score indicating better health)	Baseline and 12-week follow-up
Secondary	Health economics	Frequency of self-reported COPD-related health care contacts to estimate health care use (counts)	During the 12-week intervention