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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
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. 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

  2. Subjects must be in WHO Functional Class II-IV
  3. Subjects must be on stable clinical condition and on stable medical treatment for the underlying disease for at least three months prior to randomization
  4. Willing and able to comply with scheduled visits, treatment plan, and trial procedures
  5. 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:

  1. Patients with heart conditions other that those listed above
  2. Subjects who have unstable disease with evidence of decompensation, recent hospitalization or undergoing investigation for clinical deterioration
  3. Subjects with recent history of chest pain, palpitations, lightheadedness, dizziness, or syncope on exertion
  4. Subjects with contraindications to physical activity or with physical obstruction to perform the prescribed training program (eg patients confined on wheel chair etc)
  5. 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
  6. 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
  7. Subjects participating in any other experimental studies
  8. 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

First Posted
February 19, 2019
Last Updated
March 2, 2021
Sponsor
Aristotle University Of Thessaloniki
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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
No
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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