Telemedicine Enabling Patients in Self-care Behaviors

NCT04297735 | Completed

• 1 other identifier: HUM00156966
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrythmia

Keywords

telemedicine; self-care

Outcome Measures

Primary Outcomes (3)

• Time of recognition of an arrhythmia

  Patient recognition of a probable arrhythmia

  Up to 6 months

• Time of diagnosis of arrhythmia

  Time of diagnosis of arrhythmia by medical staff- at what point is the diagnosis present.

  Up to 6 months

• Time to treatment initiation of arrhythmia

  The time- what point in time is the treatment plan innitiated

  Up to 6 months

Secondary Outcomes (3)

• Change in self efficacy in medication use score as measured by the Medication Self Efficacy Tool (MUSE) survey

  Baseline, 6 months

• Change in functioning self efficacy score as measured by the 13 Item Shortened Function Self-efficacy Scale (FSES)

  Baseline, 6 months

• Change in self-efficacy of arrhythmia management score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA) survey

  Baseline, 6 months

Study Arms (2)

Standard of care group

ACTIVE COMPARATOR

Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months

Other: Standard of care group

Telemedicine group

EXPERIMENTAL

Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months

Behavioral: Telemedicine group; Behavioral: Telemedicine

Interventions

Standard of care group OTHER

Visits every 6 months is standard of care.

Also known as: Telemedicine

Standard of care group

Telemedicine group BEHAVIORAL

Conduct monthly telemedicine 'skype' visit

Telemedicine group

Telemedicine BEHAVIORAL

Review details of medication indication and use, activity recommendations and changes, and knowledge of arrhythmia changes and activities which are helpful with arrhythmia changes.

Telemedicine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read and speak English
• years of age or older
• Have a cardiac arrhythmia diagnosis
• Are willing to participate in the study and answer a pre and post survey.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (20)

• 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.

  BACKGROUND

• 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.

  PMID: 28916510 BACKGROUND

• 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.

  PMID: 26846446 BACKGROUND

• 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.

  PMID: 18762931 BACKGROUND

• 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.

  PMID: 17765636 BACKGROUND

• 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.

  PMID: 19604399 BACKGROUND

• Honeyman, E., Ding, H., Varnfield, M., & Karunanithi, M. Mobile health applications in cardiac care. Interventional cardiology, 6.2, 227-241, 2014.

  BACKGROUND

• 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.

  PMID: 27320955 BACKGROUND

• 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.

  PMID: 30050290 BACKGROUND

• 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.

  PMID: 25187121 BACKGROUND

• 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.

  PMID: 26635263 BACKGROUND

• 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.

  PMID: 19395894 BACKGROUND

• 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.

  PMID: 29894865 BACKGROUND

• 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.

  PMID: 21241182 BACKGROUND

• 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.

  BACKGROUND

• Tarakji, K. For arrhythmia patients, virtual visits hold plenty of virtues. Electrophysiology consult QD, 12 (2), 2016.

  BACKGROUND

• 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.

  PMID: 26239228 BACKGROUND

• 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.

  PMID: 20625110 BACKGROUND

• 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.

  PMID: 23211231 BACKGROUND

• Walfridsson, Ulla. ASTA, University Hospital, Linkoping, Sweeden, 2012.

  BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Kathleen Fasing

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Hakan Oral, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practioner

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 5, 2020
• Study Start: February 26, 2020
• Primary Completion: August 10, 2021
• Study Completion: September 20, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)