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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Hospitalization

NCT03084874

Chronic Obstructive Pulmonary Disease Physical Activity Sedentary Lifestyle

UNKNOWN NA

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

NCT01992081

COPD

WITHDRAWN PHASE4

Physical Activity Enhancing Programme in COPD

NCT02347566

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Long-term Activity Coaching in Patients With COPD

NCT04139200

COPD

COMPLETED NA

Real-Time Support for Exercise Persistence in COPD

NCT00373932

Pulmonary Disease, Chronic Obstructive COPD Emphysema +1 more

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Coaching program

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

Group Type EXPERIMENTAL

Coaching program

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No