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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Coach | Experimental | BiotechCoachForAll |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiotechCoachForAll | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The subjects' functionality assessed both prior intervention and at the end of the study | Functional capacity assessed by WHO functional class | 3 months |
| 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 | 3 months |
| 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 | 3 months |
| 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 | 3 months |
| Hospitalization | The number of hospital admissions | 3 months |
| Healthcare usage | The healthcare usage expressed by the relevant medical assistance usage | 3 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Panagiotis Bamidis, PhD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital of Thessaloniki | Thessaloniki | Greece | ||||
| Laboratory of Medical Physics, AUTH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27207191 | Background | 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. | |
| 25520374 |
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|
| Thessaloniki |
| Greece |
| Background |
| 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. |
| 27955682 | Background | 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. |
| 32364512 | Derived | 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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