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

NCT ID: NCT02717806

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-07-31

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).

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PATHway

Intervention Type: BEHAVIORAL

Patients will use the PATHway platform for 6 months

Usual care

Patients randomized to the control group will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PATHway

Patients will use the PATHway platform for 6 months

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dublin City University

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Roselien Buys

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals Leuven

Leuven, , Belgium

Beaumont Hospital

Dublin, , Ireland

Mater Misericordiae Hospital

Dublin, , Ireland

Countries

Belgium; Ireland

References

Claes J, Cornelissen V, McDermott C, Moyna N, Pattyn N, Cornelis N, Gallagher A, McCormack C, Newton H, Gillain A, Budts W, Goetschalckx K, Woods C, Moran K, Buys R. Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial. J Med Internet Res. 2020 Feb 4;22(2):e14221. doi: 10.2196/14221.

Reference Type: DERIVED

PMID: 32014842 (View on PubMed)

Claes J, Buys R, Woods C, Briggs A, Geue C, Aitken M, Moyna N, Moran K, McCaffrey N, Chouvarda I, Walsh D, Budts W, Filos D, Triantafyllidis A, Maglaveras N, Cornelissen VA. PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform. BMJ Open. 2017 Jun 30;7(6):e016781. doi: 10.1136/bmjopen-2017-016781.

Reference Type: DERIVED

PMID: 28667228 (View on PubMed)

Other Identifiers

S59023

Identifier Type: -

Identifier Source: org_study_id