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Feasibility of the "Heart-track" Rehabilitative Device Prototype

15 augusti 2019 uppdaterad av: Eng Chan Neoh, Tan Tock Seng Hospital

Feasibility of the "Heart-track" Rehabilitative Device Prototype Designed for Exercise Training Post Coronary Revascularisation

Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified 'lack of commitment', 'lack of care monitoring and continuity' and 'lack of motivation and engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By 'game-ifying' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient's comfort.

Purpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.

Methods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified 'lack of commitment', 'lack of care monitoring and continuity' and 'lack of motivation and engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By 'game-ifying' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient's comfort.

Purpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.

Methods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Minimum 21 to 65 years of age
  • conversational fluency in English
  • undergone coronary revascularisation for acute myocardial infarction within last 5 years
  • last documented ejection fraction of at least 40%
  • completed a minimum of eight supervised CR sessions
  • exercises at least once a week for a minimum duration of thirty minutes
  • at least 6 months' experience using a smartphone
  • recent experience(at least one months' experience) with any mobile app
  • displaying capacity for self-monitoring and entering data.

Exclusion Criteria:

-Abnormal physiological response during exercise

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Experimental arm
Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app.
Enhet: Heart Track

Description of the device: Wearable heart rate sensors are used in Heart-track, and a receiver on a smartphone app. Real-time wireless heart rate data is sent to paired mobile device with a wireless distance of up to 10m. The sensor is able to monitor a heart rate range of 30 to 240 beats per minute.

Another component of Heart-track is a "Heart-track" mobile app which captures and reflect real-time heart rate from the heart rate sensor. The mobile app also includes warm-up and cool down exercises that are gamified and supported on a smart-phone running on Android or iOS platforms.

The HR sensor will be purchased by our collaborator, Immersive Play Pte Ltd.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Survey
Tidsram: through study completion, an average of 3 months
Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. The survey form is a likert-scale ( Strongly agree to strongly disagree) survey that asking subjects about their feedback and satisfaction about the Heart Track hardware and software, and overall experience using Heart Track.
through study completion, an average of 3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tan Tock Seng Hospital

Utredare

  • Studierektor: Eng Chuan Neoh, masters, Senior Physiotherapist

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2018

Primärt slutförande (Faktisk)

30 september 2018

Avslutad studie (Faktisk)

30 september 2018

Studieregistreringsdatum

Först inskickad

14 augusti 2019

Först inskickad som uppfyllde QC-kriterierna

14 augusti 2019

Första postat (Faktisk)

16 augusti 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2018/00307

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Hjärthändelse

Kliniska prövningar på Heart Track

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Platser

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