Telemedicine Enabling Patients in Self-care Behaviors
2021年9月21日 更新者：Kathleen Fasing、University of Michigan
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.
研究概览
详细说明
Study will utilize the Telemedicine group and the Standard Visit group (30 patients each group) to determine
Endpoints:
- 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.
- 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
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Standard of care group
Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months
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Visits every 6 months is standard of care.
其他名称：
|
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实验性的：Telemedicine group
Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months
|
Conduct monthly telemedicine 'skype' visit
Review details of medication indication and use, activity recommendations and changes, and knowledge of arrhythmia changes and activities which are helpful with arrhythmia changes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time of recognition of an arrhythmia
大体时间：Up to 6 months
|
Patient recognition of a probable arrhythmia
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Up to 6 months
|
|
Time of diagnosis of arrhythmia
大体时间：Up to 6 months
|
Time of diagnosis of arrhythmia by medical staff- at what point is the diagnosis present.
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Up to 6 months
|
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Time to treatment initiation of arrhythmia
大体时间：Up to 6 months
|
The time- what point in time is the treatment plan innitiated
|
Up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in self efficacy in medication use score as measured by the Medication Self Efficacy Tool (MUSE) survey
大体时间：Baseline, 6 months
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MUSE is 7 items which are evaluated to identify if the patient has a good overall understanding and perception of their medicine.
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Baseline, 6 months
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Change in functioning self efficacy score as measured by the 13 Item Shortened Function Self-efficacy Scale (FSES)
大体时间：Baseline, 6 months
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The FSES is 13 questions with responses scored from 1 to 5 with a maximum score of 65.
Higher scores indicates higher level of functioning.
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Baseline, 6 months
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Change in self-efficacy of arrhythmia management score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA) survey
大体时间：Baseline, 6 months
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The ASTA questionnaire is divided into three separate parts.
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Baseline, 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kathleen Fasing、University of Michigan
- 学习椅：Hakan Oral, MD、University of Michigan
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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. Erratum In: Heart Rhythm. 2007 Dec;4(12):1590.
- 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, 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年2月26日
初级完成 (实际的)
2021年8月10日
研究完成 (实际的)
2021年9月20日
研究注册日期
首次提交
2020年2月28日
首先提交符合 QC 标准的
2020年3月3日
首次发布 (实际的)
2020年3月5日
研究记录更新
最后更新发布 (实际的)
2021年9月22日
上次提交的符合 QC 标准的更新
2021年9月21日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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