Clinical trial NCT04297735: Telemedicine Enabling Patients in Self-care Behaviors
Official title: Telemedicine Enabling Patients in Self-care Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrythmia
Keywords: telemedicine
self-care
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to see if monthly telemedicine computer visits (visits using the computer) improve the time it takes to identify and treat an arrhythmia. The second purpose is to see if monthly telemedicine computer visits improves the participant's understanding of the arrhythmia and improves how the participant feels with daily activities.

Detailed description: Study will utilize the Telemedicine group and the Standard Visit group (30 patients each group) to determine

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

Eligibility criteria: Inclusion Criteria:

* Read and speak English
* 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:

* Any difficulty in understanding the study
* Does not have internet or a cell phone data plan
* Any life threatening arrhythmias
* Objection to working with nurse practitioners and physician assistants

Primary outcomes:
measure: Time of recognition of an arrhythmia
timeFrame: Up to 6 months
measure: Time of diagnosis of arrhythmia
timeFrame: Up to 6 months
measure: Time to treatment initiation of arrhythmia
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in self efficacy in medication use score as measured by the Medication Self Efficacy Tool (MUSE) survey
timeFrame: Baseline, 6 months
measure: Change in functioning self efficacy score as measured by the 13 Item Shortened Function Self-efficacy Scale (FSES)
timeFrame: Baseline, 6 months
measure: Change in self-efficacy of arrhythmia management score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA) survey
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kathleen Fasing
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Hakan Oral, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Honeyman, E., Ding, H., Varnfield, M., & Karunanithi, M. Mobile health applications in cardiac care. Interventional cardiology, 6.2, 227-241, 2014.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Tarakji, K. For arrhythmia patients, virtual visits hold plenty of virtues. Electrophysiology consult QD, 12 (2), 2016.
citation: 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.
citation: 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.
citation: 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.
citation: Walfridsson, Ulla. ASTA, University Hospital, Linkoping, Sweeden, 2012.