A Pilot- and Feasibility Trial of the EHealth Tool My COPD for People with COPD

NCT ID: NCT05086341

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2023-10-01

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Telemedicine; Telerehabilitation; eHealth; Participatory; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

My COPD

In addition to usual care, participants in the intervention group will receive a 12-week, twice a week, physiotherapist-supported individualized exercise program and physical activity plan via the eHealth tool My COPD.

Group Type: EXPERIMENTAL

My COPD

Intervention Type: DEVICE

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.

Usual care

Participants in the control group will receive usual care only. Usual care is recommended to include, but not restricted to, long-acting anticholinergics and long-acting ß2-antagonists with 24-hour duration and support for smoking cessation, PA and exercise, self-management and nutrition.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Wadell, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Karolinska Intitutet

Stockholm, , Sweden

Umeå university

Umeå, , Sweden

Countries

Sweden

References

Karlsson A, Sonnerfors P, Lundell S, Toots A, Wadell K. Evaluation of a Novel eHealth Tool for Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease: Randomized Controlled Pilot and Feasibility Trial. JMIR Form Res. 2025 Jun 23;9:e68195. doi: 10.2196/68195.

Reference Type: DERIVED

PMID: 40550122 (View on PubMed)

Other Identifiers

2020-01957

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20190406

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RV-939255

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Feasibility My COPD

Identifier Type: -

Identifier Source: org_study_id