Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-02-26
2021-09-20
Brief Summary
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Detailed Description
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Endpoints:
1. Time of recognition, time of diagnosis and time of intervention for arrhythmia. These times will be noted for each patient in each group and look for any difference in these times based upon gaining information from telemedicine visits versus 6 month follow up visit.
2. Three surveys of patient Self efficacy of medications, activity, and arrhythmia knowledge utilizing three surveys in each group. Surveys will be answered at the start of the study and end of the study by every patient within each group.
Surveys:
MUSE- Medication Understanding and Self Efficacy Tool Shortened FSES- Functioning self efficacy scale ASTA- Arrhythmia specific symptoms and health related quality of life in connection with heart rhythm disturbance
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard of care group
Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months
Standard of care group
Visits every 6 months is standard of care.
Telemedicine group
Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months
Telemedicine group
Conduct monthly telemedicine 'skype' visit
Telemedicine
Review details of medication indication and use, activity recommendations and changes, and knowledge of arrhythmia changes and activities which are helpful with arrhythmia changes.
Interventions
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Standard of care group
Visits every 6 months is standard of care.
Telemedicine group
Conduct monthly telemedicine 'skype' visit
Telemedicine
Review details of medication indication and use, activity recommendations and changes, and knowledge of arrhythmia changes and activities which are helpful with arrhythmia changes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Have a cardiac arrhythmia diagnosis
* Are willing to participate in the study and answer a pre and post survey.
Exclusion Criteria
* Does not have internet or a cell phone data plan
* Any life threatening arrhythmias
* Objection to working with nurse practitioners and physician assistants
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Kathleen Fasing
Nurse Practioner
Principal Investigators
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Kathleen Fasing
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Hakan Oral, MD
Role: STUDY_CHAIR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Anderson, T, Bansler, J., Kensing, F. & Moll, J., Aligning concerns in telecare: Three concepts to guide the design of patient centered e-health, Computer supported cooperative work, 3 (6), 1181-1214, 2018.
Dalouk K, Gandhi N, Jessel P, MacMurdy K, Zarraga IG, Lasarev M, Raitt M. Outcomes of Telemedicine Video-Conferencing Clinic Versus In-Person Clinic Follow-Up for Implantable Cardioverter-Defibrillator Recipients. Circ Arrhythm Electrophysiol. 2017 Sep;10(9):e005217. doi: 10.1161/CIRCEP.117.005217.
Dixon DL, Dunn SP, Kelly MS, McLlarky TR, Brown RE. Effectiveness of Pharmacist-Led Amiodarone Monitoring Services on Improving Adherence to Amiodarone Monitoring Recommendations: A Systematic Review. Pharmacotherapy. 2016 Feb;36(2):230-6. doi: 10.1002/phar.1697. Epub 2016 Feb 5.
Estrada JC, Darbar D. Clinical use of and future perspectives on antiarrhythmic drugs. Eur J Clin Pharmacol. 2008 Dec;64(12):1139-46. doi: 10.1007/s00228-008-0555-x. Epub 2008 Sep 2.
Goldschlager N, Epstein AE, Naccarelli GV, Olshansky B, Singh B, Collard HR, Murphy E; Practice Guidelines Sub-committee, North American Society of Pacing and Electrophysiology (HRS). A practical guide for clinicians who treat patients with amiodarone: 2007. Heart Rhythm. 2007 Sep;4(9):1250-9. doi: 10.1016/j.hrthm.2007.07.020. Epub 2007 Jul 20.
Harden M, Nystrom B, Kulich K, Carlsson J, Bengtson A, Edvardsson N. Validity and reliability of a new, short symptom rating scale in patients with persistent atrial fibrillation. Health Qual Life Outcomes. 2009 Jul 15;7:65. doi: 10.1186/1477-7525-7-65.
Honeyman, E., Ding, H., Varnfield, M., & Karunanithi, M. Mobile health applications in cardiac care. Interventional cardiology, 6.2, 227-241, 2014.
Klein-Wiele O, Faghih M, Dreesen S, Urbien R, Abdelghafor M, Kara K, Schulte-Hermes M, Garmer M, Gronemeyer D, Hailer B. A novel cross-sector telemedical approach to detect arrhythmia in primary care patients with palpitations using a patient-activated event recorder. Cardiol J. 2016;23(4):422-8. doi: 10.5603/CJ.a2016.0033. Epub 2016 Jun 20.
Lamarche L, Tejpal A, Mangin D. Self-efficacy for medication management: a systematic review of instruments. Patient Prefer Adherence. 2018 Jul 20;12:1279-1287. doi: 10.2147/PPA.S165749. eCollection 2018.
Lowres N, Redfern J, Freedman SB, Orchard J, Bennett AA, Briffa T, Bauman A, Neubeck L. Choice of Health Options In prevention of Cardiovascular Events for people with Atrial Fibrillation (CHOICE-AF): A pilot study. Eur J Cardiovasc Nurs. 2016 Feb;15(1):39-46. doi: 10.1177/1474515114549687. Epub 2014 Sep 3.
Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial. Geriatr Gerontol Int. 2016 Nov;16(11):1188-1195. doi: 10.1111/ggi.12612. Epub 2015 Dec 4.
Ryan P. Integrated Theory of Health Behavior Change: background and intervention development. Clin Nurse Spec. 2009 May-Jun;23(3):161-70; quiz 171-2. doi: 10.1097/NUR.0b013e3181a42373.
Ryan P, Papanek P, Csuka ME, Brown ME, Hopkins S, Lynch S, Scheer V, Schlidt A, Yan K, Simpson P, Hoffman R; Striving to be Strong Team. Background and method of the Striving to be Strong study a RCT testing the efficacy of a m-health self-management intervention. Contemp Clin Trials. 2018 Aug;71:80-87. doi: 10.1016/j.cct.2018.06.006. Epub 2018 Jun 9.
Suter P, Suter WN, Johnston D. Theory-based telehealth and patient empowerment. Popul Health Manag. 2011 Apr;14(2):87-92. doi: 10.1089/pop.2010.0013. Epub 2011 Jan 17.
Sutton, B. D'Oranzio, Gopinethannair, R. Developing a robust monitoring program in your practice: Clinical, economic, and workflow considerations. Electrophysiology Lab Digest, 13 (2), 2013.
Tarakji, K. For arrhythmia patients, virtual visits hold plenty of virtues. Electrophysiology consult QD, 12 (2), 2016.
Tovel H, Carmel S. Function Self-Efficacy Scale-FSES: Development, Evaluation, and Contribution to Well-Being. Res Aging. 2016 Aug;38(6):643-64. doi: 10.1177/0164027515596583. Epub 2015 Aug 2.
Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.
Varma N, Ricci RP. Telemedicine and cardiac implants: what is the benefit? Eur Heart J. 2013 Jul;34(25):1885-95. doi: 10.1093/eurheartj/ehs388. Epub 2012 Dec 4.
Walfridsson, Ulla. ASTA, University Hospital, Linkoping, Sweeden, 2012.
Other Identifiers
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HUM00156966
Identifier Type: -
Identifier Source: org_study_id
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