Cardiovascular DiseasePATHwayNCT02717806
Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
A study testing PATHway in people with Cardiovascular Disease, run by KU Leuven at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- PATHway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2017to 31 Jul 2018
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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
- Being tested
- PATHway
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATHwayBehavioural
Patients will use the PATHway platform for 6 months
| Study group | Role | What they receive |
|---|---|---|
| PATHway | Experimental | 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. Receives: Behavioral: PATHway |
| Usual care | No intervention | Patients randomized to the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total volume of weekly active energy expenditure
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start1 Jun 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Dublin City University
- Responsible party
- Principal investigator, Roselien Buys, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717806
- Sponsor's protocol ID
- S59023
- Acronym
- PATHway
- Status last verified
- Jan 2019
- First submitted
- 18 Mar 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32014842Claes 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.
PubMed 28667228
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT02717806
- Acronym / sponsor ID
- PATHway / S59023
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Dublin City University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATHway | Experimental | Behavioral: PATHwayPatients 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. |
| Usual care | No intervention | –Patients randomized to the control group will receive usual care. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATHwayPatients will use the PATHway platform for 6 months | Behavioural | PATHway |
Primary outcome
Change in total volume of weekly active energy expenditure
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 32014842Claes 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.
- Derived from this study: PubMed 28667228Claes 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.
- project websiteLink provided by the sponsor.
Related trials for Cardiovascular Disease
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATHway in people with Cardiovascular Disease, run by KU Leuven at 3 sites in 2 countries.
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 12 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: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in total volume of weekly active energy expenditure (time frame: 3 and 6 months). 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 NCT02717806, which also lists 2 linked publications.
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 16 Jan 2019.