Dance4Healing: Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter-defibrillator (ICD)
3. maj 2021 opdateret af: Sanjiv Narayan, MD, PhD
Dance4Healing: A Pilot Study to Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter Defibrillator
This study is to determine if it is feasible to using a Telehealth Dance Platform with patients that have an implantable Cardioverter Defibrillator, and will compare the activity engagement, anxiety, and Quality of Life
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Stanford, California, Forenede Stater, 94303
- Stanford Arrhythmia Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients that have had an ICD implanted for at least 1 month
- Patients have access to web-based on-line programs
- Patient can provide cardiac clearance for exercise from their treating physician OR they have written stress test results from within the last 6 months indicating no ischemia.
- Patient is 18 years old or greater.
Exclusion Criteria:
- Patient is non-English speaking.
- Patient is assessed as having NYHA Class IV heart failure.
- Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received "tachy" therapy from their ICD within last 4 weeks.
- Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks.
- Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Dance4Healing control group
Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results).
During the intervention period, this group will not have a dance buddy.
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Week 1: 2-hour introduction session on Zoom platform with a live dance instructor at the participant's desired level of activity intensity (low, mild, or moderate). Weeks 2-8: All participants will be asked to participate in a 1 hour online, instructor-led live class. |
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Eksperimentel: Dance4Healing Buddy Group
Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results).
During the intervention period, this group will have a dance buddy.
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Week 1: 2-hour introduction session on Zoom platform with a live dance instructor at the participant's desired level of activity intensity (low, mild, or moderate). Weeks 2-8: All participants will be asked to participate in a 1 hour online, instructor-led live class.
Following randomization (beginning of intervention period) half of the participants will be assigned a dance "buddy," and will be asked to dance with their buddies using the Dance4Healing TLVP at least 2 additional times/week.
This group will have 24/7 access to Dance4Healing Platform during the intervention and post-intervention periods.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Activity in hours/day from ICD interrogation as a measure of activity engagement over time
Tidsramme: 36 weeks
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36 weeks
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Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
Tidsramme: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
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Scores range from 0-100, higher scores represent higher engagement self reported survey
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Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
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Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention
Tidsramme: Total time in minutes over the 8 week intervention period
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Total number of minutes that the participant accesses the Dance4Healing platform each week
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Total time in minutes over the 8 week intervention period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Anxiety Score over time
Tidsramme: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
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Anxiety will be a calculated score from a 10 question self-reported questionnaire (Florida Shock Anxiety Scale) with a scoring range from 0-50, with higher scores indicating more anxiety.
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Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Linda K Ottoboni, PhD, Stanford Healthcare
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. januar 2020
Primær færdiggørelse (Faktiske)
31. december 2020
Studieafslutning (Faktiske)
31. december 2020
Datoer for studieregistrering
Først indsendt
9. december 2020
Først indsendt, der opfyldte QC-kriterier
16. december 2020
Først opslået (Faktiske)
21. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB # 58348
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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