Study to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD.

Phase 4

Withdrawn

• Conditions: COPD
• Interventions: Device: Automated telehealth system; Other: Usual care

• Registration Number: NCT01992081
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will test two instruments to measure physical activity in COPD patients: A questionnaire and two small physical activity monitors .Patients will be randomized to either receive the telecoaching program in addition to usual care or only the usual care. Study will include around 510 patients in 5 countries in Europe.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) has a negative influence on physical activity hence it may be beneficial for patients to increase physical activity levels. This study will test two instruments to measure physical activity: A questionnaire (completed on a personal digital assistant) and a physical activity monitor which patient wear during the day. Patients will be randomized to either receive the Telecoaching program in addition to usual care or only the usual care. The study will involve 4 clinic visits as well as some phone calls over duration of 6 months.

Study Timeline

• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Status Verified: 2014-05
• Study Start: 2014-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Written informed consent
• Male and female patients ≥ 40 years of age
• Diagnosis of COPD (GOLD criterion: post bronchodilator FEV1/FVC< 70%)
• Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
• Patients should have at least 4 days of physical activity data recorded via activity monitor during 7 days prior to visit 101.

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study.

• 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.
• Respiratory diseases other than COPD (e.g. asthma)
• Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the health base and PDA, as judged by the investigator
• Participating in or scheduled to start a 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.
• Women of child-bearing potential who have the intention to become pregnant during the course of the study and pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β-hCG laboratory test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telecoaching	Usual care	Participants will receive daily coaching by an automated telehealth system and coaching by the investigator during study visits, in addition to the usual care.
Telecoaching	Automated telehealth system	Participants will receive daily coaching by an automated telehealth system and coaching by the investigator during study visits, in addition to the usual care.
Control	Usual care	Participants will receive the usual care but will NOT receive daily coaching by telehealth system.

Primary Outcome Measures

Name	Time	Method
The construct validity of the PROactive instrument.	6 months	Construct validity of the PROactive instrument will be measured via the use of two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire.
The responsiveness of the PROactive instrument.	6 months	Responsiveness of the PROactive instrument will be measured via the use of two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire.
The impact of telecoaching program on the physical activity	6 months	Impact of telecoaching program on the physical activity of COPD patients will be measured via the use of two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire.