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

NCT01992081 | Withdrawn Phase 4

• 1 other identifier: CIDD001D2101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Keywords

COPD, Physical Activity, Telecoaching, PROactive

Outcome Measures

Primary Outcomes (3)

• The impact of telecoaching program on the physical activity

  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.

  6 months

• The construct validity of the PROactive instrument.

  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.

  6 months

• The responsiveness of the PROactive instrument.

  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.

  6 months

Study Arms (2)

Telecoaching

EXPERIMENTAL

Participants will receive daily coaching by an automated telehealth system and coaching by the investigator during study visits, in addition to the usual care.

Device: Automated telehealth system; Other: Usual care

Control

OTHER

Participants will receive the usual care but will NOT receive daily coaching by telehealth system.

Other: Usual care

Interventions

Automated telehealth system DEVICE

The automated telehealth system (used within its intended use) comprises of CE marked medical devices and a CE marked step counter (Fitbug®), all being used within their intended use. Coaching by investigators is performed during the study visits and is aimed to enhance physical activity in patients across a spectrum of COPD severity, in addition to the usual care.

Also known as: telehealth system

Telecoaching

Usual care OTHER

Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD)

Control; Telecoaching

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Innovative Medicines Initiative: collaborator

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

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Innovative Medicines Initiative

  PROactive is part of the European Innovative Medicines Initiative (IMI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 20, 2017

Record last verified: 2014-05