Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness

Cardiovascular Disease Clinical Trial

— PATHway  

Official title:

Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717806
• Other study ID #: S59023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• PATHway
Patients will use the PATHway platform for 6 months

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Dublin City University

Countries where clinical trial is conducted

Belgium,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total volume of weekly active energy expenditure		3 and 6 months

External Links

•   project website