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Trial record 1 of 5849 for:    PATHway
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Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness (PATHway)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717806
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Dublin City University
Information provided by (Responsible Party):
Roselien Buys, KU Leuven

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
Change in total volume of weekly active energy expenditure [ Time Frame: 3 and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
Official Title  ICMJE Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
Brief Summary

The PATHway system is designed to help patients remain physically active and maintain a good cardiovascular health. It proposes a novel approach that aims to empower patients to self-manage their CVD, set within a collaborative care context with health professionals. This will be achieved via a patient-centric holistic approach that specifically addresses the above barriers. It involves an internet-enabled and sensor-based home exercise platform. It is represented by several modules with an exercise module as the core component which will provide individualized rehabilitation programs that use regular, socially inclusive exercise sessions as the basis upon which to provide a personalized, comprehensive lifestyle intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable patients to both better understand and deal with their own condition and to lead a healthier lifestyle in general.

The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle and health related physical fitness and cost-effectiveness of the PATHway intervention in patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE Behavioral: PATHway
Patients will use the PATHway platform for 6 months
Study Arms  ICMJE
  • Experimental: PATHway

    Patients allocated to the PATHway intervention will be given a 4 week run-in period as an outpatient to get acquainted with the system. During this run-in period, the PATHway system will also be installed in each participant's home. They will be provided with a training manual and a quick set up guide for getting started with PATHway in the home.

    After this 4 week run-in period, the PATHway system will be set up for each individual patient including a patient specific exercise prescription. The patient will then exercise with the PATHway platform for 6 months.

    Intervention: Behavioral: PATHway
  • No Intervention: Usual care
    Patients randomized to the control group will receive usual care.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women with documented CVD
  • age 40-80 yrs
  • patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
  • patients must have completed the ambulatory CR program and received clinical approval from their treating physician to continue exercising outside the hospital program
  • internet access at home

Exclusion Criteria:

  • significant illness during the last 6 weeks
  • known severe ventricular arrhythmia with functional or prognostic significance
  • significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
  • cardiac disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
  • co-morbidity that may significantly influence one-year prognosis
  • functional or mental disability that may limit exercise
  • acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
  • GFR <25ml/min/1.73m2
  • hemoglobin < 10g/dl
  • severe chronic obstructive pulmonary disease (FEV1 < 50%)
  • NYHA class 4
  • participation in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717806
Other Study ID Numbers  ICMJE S59023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roselien Buys, KU Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE Dublin City University
Investigators  ICMJE Not Provided
PRS Account KU Leuven
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP