Impact of "Telecoaching Program" on Physical Activity in Patients With COPD (MrPAPP)

A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)

The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Coaching program

Detailed Description

In this 3 month, randomized (1:1 ratio), parallel-group, multicenter trial, patients in both groups (control and coaching) will receive information and guidance on the benefits associated with increased physical activity in COPD patients and their health status. Patients in both groups will use two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire. In addition to above, the patients in the coaching group will receive daily coaching by a semiautomated system and coaching by the investigator during study visits.

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • KULeuven
• Greece
  • Athens, Greece
    • Thorax Research Foundation
• Netherlands
  • Groningen, Netherlands
    • University Medical Center
• Switzerland
  • Zurich, Switzerland
    • University of Zurich
• United Kingdom
  • Edinburgh, United Kingdom
    • University of Edinburgh
  • London, United Kingdom
    • Royal Brompton Hospital, Imperial College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed
• Male and female patients ≥ 40 years of age
• Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC< 70%)
• Current or ex-smokers with a smoking history equivalent to at least 10 pack years
• Patient should have at least 4 days of physical activity data recorded via PROactive monitors during 7 days prior to the baseline measurement

Exclusion Criteria:

• Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased, then they should not be enrolled
• Respiratory diseases other than COPD (e.g. asthma)
• Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the smartphone and PDA, as judged by the investigator
• Participating in or scheduled to start an outpatient rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status
Experimental: Coaching program; In addition to usual care, patients will receive the coaching program	Other: Coaching program; The coaching program consists of a (1) Step counter used as a coaching activity monitor to collect number of steps walked by the patients and (2) the Linkcare System, a mobile phone or tablet PC placed in the patient's home to collect data from the step counter. The system will set a daily activity goal for the patient based on achieved activity levels which will be measured by the step counter. Patients will also receive feedback, motivational and educational messages and direct calls from the coaching team at each institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily number of steps	The daily number of steps will be measured by the PROactive monitors (ActiGraph® and DynaPort®) at baseline (during the week prior to baseline visit) and at the end of the 3-month epoch (during the week prior to end visit).	changes from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in at least moderate physical activity	Time in at least moderate physical activity will be measured by the PROactive monitors (ActiGraph® and DynaPort®) at baseline (during the week prior to baseline visit) and at the end of the 3-month epoch (during the week prior to end visit).	changes from baseline to 3 months
Proportion of patients showing an increase of physical activity by >20%	Physical activity will be measured by the PROactive monitors (ActiGraph® and DynaPort®) at baseline (during the week prior to baseline visit) and at the end of the 3-month epoch (during the week prior to end visit).	changes from baseline to 3 months
6-minute walking test		changes from baseline to 3 months
isometric Quadriceps force		changes from baseline to 3 months
COPD symptoms and health-related quality of life	COPD symptoms and health-related quality of life will be measured by the CAT, CCQ, HADS and mMRC questionnaires	changes form baseline to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
daily and clinic visit version of PROactive instrument		changes from baseline to 3 months
Satisfaction with the telecoaching program	Questionnaire and qualitative interview about the patients' experience	Information gathered after 3 months of intervention
Compliance with the telecoaching program	Compliance of wearing the step counter and performing the tasks of the smartphone interface	Information gathered after 3 months of intervention

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: University of Zurich; University Medical Center Groningen; University of Athens; University of Edinburgh; Royal Brompton & Harefield NHS Foundation Trust; Barcelona Institute for Global Health
• Investigators: Study Chair: Thierry Troosters, PT, PHD, KU Leuven; Study Chair: Mike Polkey, MD, PHD, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

General Publications

• Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, Gimeno-Santos E, Rodrigues FM, Buttery SC, Hopkinson NS, Busching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. JMIR Mhealth Uhealth. 2018 Dec 21;6(12):e200. doi: 10.2196/mhealth.9774.
• Demeyer H, Louvaris Z, Frei A, Rabinovich RA, de Jong C, Gimeno-Santos E, Loeckx M, Buttery SC, Rubio N, Van der Molen T, Hopkinson NS, Vogiatzis I, Puhan MA, Garcia-Aymerich J, Polkey MI, Troosters T; Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017 May;72(5):415-423. doi: 10.1136/thoraxjnl-2016-209026. Epub 2017 Jan 30.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; Chronic obstructive pulmonary disease (COPD); PROactive; telecoaching
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ML9814