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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— MrPAPP  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158065
• Other study ID #: ML9814
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: April 30, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Centre for Research in Environmental Epidemiology, Spain, Royal Brompton & Harefield NHS Foundation Trust, University Medical Center Groningen, University of Athens, University of Edinburgh, University of Zurich

Countries where clinical trial is conducted

Belgium,  Greece,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	daily and clinic visit version of PROactive instrument		changes from baseline to 3 months	No
Other	Satisfaction with the telecoaching program	Questionnaire and qualitative interview about the patients' experience	Information gathered after 3 months of intervention	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	6-minute walking test		changes from baseline to 3 months	No
Secondary	isometric Quadriceps force		changes from baseline to 3 months	No
Secondary	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	No