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

NCT05086341 | Completed

• 4 other identifiers: Feasibility My COPD2020-0195720190406RV-939255
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Telemedicine; Telerehabilitation; eHealth; Participatory; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Physical capacity

  Baseline and 12-week follow-up

• Physical capacity

  Baseline and 12-week follow-up

• Physical capacity

  Baseline and 12-week follow-up

• Physical capacity

  Baseline and 12-week follow-up

• Level of physical activity

  Accelerometer wear (7 days prior to intervention commencement) and at 12-week follow-up

Other Outcomes (4)

• Exercise intensity

  During the 12-week intervention

• Adverse events

  During the 12-week intervention

• Adherence

  During the 12-week intervention

Study Arms (2)

My COPD

EXPERIMENTAL

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.

Device: My COPD

Usual care

NO INTERVENTION

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.

Interventions

My COPD 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.

My COPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a confirmed diagnosis of COPD

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Karolinska Intitutet

Stockholm, Sweden

Location

Umeå university

Umeå, Sweden

Location

Related Publications (1)

• 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.

  PMID: 40550122 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Karin Wadell, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, randomized controlled pilot- and feasibility trial, 2:1 (I:C) randomization.

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 20, 2021
• Study Start: November 5, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)