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COPDPhase 4PROactiveNCT01992081

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

A Phase 4 study testing Automated telehealth system in people with COPD, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COPD
What is being tested?
Automated telehealth system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2014to Jun 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: A 6-month Multicenter Randomized Trial to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD

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.

Read the 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.

Conditions
COPD
Being tested
Automated telehealth system, Usual care
Keywords
COPD, Physical Activity, Telecoaching, PROactive
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated telehealth systemDevice

    Also called telehealth system

    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.

  • Usual careOther

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

Study groups in NCT01992081
Study groupRoleWhat they receive
TelecoachingExperimentalParticipants will receive daily coaching by an automated telehealth system and coaching by the investigator during study visits, in addition to the usual care.
Receives: Device: Automated telehealth system; Other: Usual care
ControlOtherParticipants will receive the usual care but will NOT receive daily coaching by telehealth system.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01992081
Sponsor's protocol ID
CIDD001D2101
Acronym
PROactive
Status last verified
May 2014
First submitted
11 Nov 2013
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Automated telehealth system in people with COPD, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The impact of telecoaching program on the physical activity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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