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

NCT02158065 | Completed

• 1 other identifier: ML9814
• Study Type: interventional
• Target: 370
• Locations: 5 countries
• Sites: 6

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease (COPD); physical activity; PROactive; telecoaching

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time spent in at least moderate physical activity

  changes from baseline to 3 months

• Proportion of patients showing an increase of physical activity by >20%

  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

  changes form baseline to 3 months

Other Outcomes (3)

• daily and clinic visit version of PROactive instrument

  changes from baseline to 3 months

• Satisfaction with the telecoaching program

  Information gathered after 3 months of intervention

• Compliance with the telecoaching program

  Information gathered after 3 months of intervention

Study Arms (2)

Usual care

NO INTERVENTION

Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status

Coaching program

EXPERIMENTAL

In addition to usual care, patients will receive the coaching program

Other: Coaching program

Interventions

Coaching program OTHER

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.

Coaching program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• University of Edinburgh: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• University Medical Center Groningen: collaborator
• University of Athens: collaborator
• University of Zurich: collaborator
• Barcelona Institute for Global Health: collaborator

Study Sites (6)

KULeuven

Leuven, 3000, Belgium

Location

Thorax Research Foundation

Athens, Greece

Location

University Medical Center

Groningen, Netherlands

Location

University of Zurich

Zurich, Switzerland

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

Royal Brompton Hospital, Imperial College

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30578215 DERIVED

• 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.

  PMID: 28137918 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

• Thierry Troosters, PT, PHD

  KU Leuven

  STUDY CHAIR

• Mike Polkey, MD, PHD

  Royal Brompton & Harefield NHS Foundation Trust

  STUDY CHAIR

• Judith Garcia-Aymerich, MD, PHD

  Barcelona Institute for Global Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 6, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

GB (2); BE (1); NL (1); GR (1); CH (1)