Clinical trial NCT01992081: Study to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD.
Official title: A 6-month Multicenter Randomized Trial to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COPD
Keywords: COPD, Physical Activity, Telecoaching, PROactive
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Innovative Medicines Initiative
First posted: 2013-11-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The impact of telecoaching program on the physical activity
timeFrame: 6 months
measure: The construct validity of the PROactive instrument.
timeFrame: 6 months
measure: The responsiveness of the PROactive instrument.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: PROactive is part of the European Innovative Medicines Initiative (IMI)
name: Innovative Medicines Initiative
role: PRINCIPAL_INVESTIGATOR
References: