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BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

BiotechCoachForAll

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring heart failure, exercise, life coach

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients aged >55 years old with any of the following conditions, diagnosed according to appropriate international guidelines criteria
a) Heart failure of any etiology, with either reduced or preserved ejection fraction
Subjects must be in WHO Functional Class II-IV
Subjects must be on stable clinical condition and on stable medical treatment for the underlying disease for at least three months prior to randomization
Willing and able to comply with scheduled visits, treatment plan, and trial procedures
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

Patients with heart conditions other that those listed above
Subjects who have unstable disease with evidence of decompensation, recent hospitalization or undergoing investigation for clinical deterioration
Subjects with recent history of chest pain, palpitations, lightheadedness, dizziness, or syncope on exertion
Subjects with contraindications to physical activity or with physical obstruction to perform the prescribed training program (eg patients confined on wheel chair etc)
Subjects with any severe acute or chronic medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results
Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator
Subjects participating in any other experimental studies
Subjects not willing to provide signed informed consent.

Sites / Locations

AHEPA University Hospital of Thessaloniki
Laboratory of Medical Physics, AUTH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Coach

Arm Description

BiotechCoachForAll

Outcomes

Primary Outcome Measures

The subjects' functionality assessed both prior intervention and at the end of the study

Functional capacity assessed by WHO functional class

The subjects' exercise intolerance assessed both prior intervention and at the end of the study

Exercise intolerance assessed by distance walked in six-minute walk test

The subjects' quality of life assessed both prior intervention and at the end of the study

Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires -SF-36 questionnaire

The subjects' quality of life assessed both prior intervention and at the end of the study

Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires -Dukes questionnaire

Hospitalization

The number of hospital admissions

Healthcare usage

The healthcare usage expressed by the relevant medical assistance usage

Secondary Outcome Measures

Full Information

NCT ID

NCT03877328

First Posted

February 19, 2019

Last Updated

March 2, 2021

Sponsor

Aristotle University Of Thessaloniki

1. Study Identification

Unique Protocol Identification Number

NCT03877328

Brief Title

BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

Official Title

BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

July 18, 2018 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This would be a single center, parallel, two group randomized controlled pilot study that is designed to assess the feasibility and efficacy of the Virtual Coach Program in elderly patients with heart failure. Sixteen (16) subjects will be enrolled to allow 8 subjects to be randomly assigned to each arm. The study will be conducted in Thessaloniki/Greece. The study is expected to complete enrollment in approximately 3 months. Participants will be randomly randomized to either the intervention group (use of Virtual Coach program and usual care) or the control group (use of usual care alone) after successfully fulfilling all inclusion and exclusion criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

heart failure, exercise, life coach

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Coach

Arm Type

Experimental

Arm Description

BiotechCoachForAll

Intervention Type

Other

Intervention Name(s)

BiotechCoachForAll

Intervention Description

A group of thirty subjects diagnosed with heart failure (HF) of any etiology undergo an experimental procedure in the following order: resting-state (eyes-closed), passively viewing thirty two agents which are grouped with respect to different appearance characteristics and passively viewing combinations of virtual agents. During the experiment, brain activity, heart rate, skin conductance, temperature and eye-gaze biosignals are collected by means of electroencephalography, Empatica E4 and Gazepoint. Subsequently, a prospective cohort study is performed in a subgroup of ten participants which undergo a three additive stage procedure. Stage 1, a wearable monitoring device (Wavelet Health) is given in order to provide objective information on the patient's activity. Stage 2, the FitForAll physical exercise program is introduced. Stage 3, introduces the coaching aspects, where personalized recommendations and suggestions are delivered through home surfaces' projection.

Primary Outcome Measure Information:

Title

The subjects' functionality assessed both prior intervention and at the end of the study

Description

Functional capacity assessed by WHO functional class

Time Frame

3 months

Title

The subjects' exercise intolerance assessed both prior intervention and at the end of the study

Description

Exercise intolerance assessed by distance walked in six-minute walk test

Time Frame

3 months

Title

The subjects' quality of life assessed both prior intervention and at the end of the study

Description

Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires -SF-36 questionnaire

Time Frame

3 months

Title

The subjects' quality of life assessed both prior intervention and at the end of the study

Description

Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires -Dukes questionnaire

Time Frame

3 months

Title

Hospitalization

Description

The number of hospital admissions

Time Frame

3 months

Title

Healthcare usage

Description

The healthcare usage expressed by the relevant medical assistance usage

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients aged >55 years old with any of the following conditions, diagnosed according to appropriate international guidelines criteria a) Heart failure of any etiology, with either reduced or preserved ejection fraction Subjects must be in WHO Functional Class II-IV Subjects must be on stable clinical condition and on stable medical treatment for the underlying disease for at least three months prior to randomization Willing and able to comply with scheduled visits, treatment plan, and trial procedures Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: Patients with heart conditions other that those listed above Subjects who have unstable disease with evidence of decompensation, recent hospitalization or undergoing investigation for clinical deterioration Subjects with recent history of chest pain, palpitations, lightheadedness, dizziness, or syncope on exertion Subjects with contraindications to physical activity or with physical obstruction to perform the prescribed training program (eg patients confined on wheel chair etc) Subjects with any severe acute or chronic medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator Subjects participating in any other experimental studies Subjects not willing to provide signed informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Panagiotis Bamidis, PhD

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

AHEPA University Hospital of Thessaloniki

City

Thessaloniki

Country

Greece

Facility Name

Laboratory of Medical Physics, AUTH

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

27207191

Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

Results Reference

background

PubMed Identifier

25520374

Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.

Results Reference

background

PubMed Identifier

27955682

Citation

Cichosz SL, Ehlers LH, Hejlesen O. Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):590. doi: 10.1186/s13063-016-1722-5.

Results Reference

background

PubMed Identifier

32364512

Citation

Billis A, Pandria N, Mouratoglou SA, Konstantinidis E, Bamidis P. Development of Cognitive and Physical Exercise Systems, Clinical Recordings, Large-Scale Data Analytics, and Virtual Coaching for Heart Failure Patients: Protocol for the BioTechCOACH-ForALL Project. JMIR Res Protoc. 2020 May 4;9(5):e17714. doi: 10.2196/17714.

Results Reference

derived

Learn more about this trial

BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

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