Telemedicine Enabling Patients in Self-care Behaviors

Not Applicable

Completed

• Conditions: Arrythmia
• Interventions: Other: Standard of care group; Behavioral: Telemedicine group; Behavioral: Telemedicine

• Registration Number: NCT04297735
• Lead Sponsor: University of Michigan

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-26
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2021-08-10
• Status Verified: 2021-09
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care group	Standard of care group	Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months
Telemedicine group	Telemedicine	Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months
Telemedicine group	Telemedicine group	Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months

Primary Outcome Measures

Name	Time	Method
Time of recognition of an arrhythmia	Up to 6 months	Patient recognition of a probable arrhythmia
Time of diagnosis of arrhythmia	Up to 6 months	Time of diagnosis of arrhythmia by medical staff- at what point is the diagnosis present.
Time to treatment initiation of arrhythmia	Up to 6 months	The time- what point in time is the treatment plan innitiated

Secondary Outcome Measures

Name	Time	Method
Change in functioning self efficacy score as measured by the 13 Item Shortened Function Self-efficacy Scale (FSES)	Baseline, 6 months	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.
Change in self-efficacy of arrhythmia management score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA) survey	Baseline, 6 months	The ASTA questionnaire is divided into three separate parts.; * Part 1 is descriptive data that evaluates the patient's latest episode of arrhythmia and his/her pharmaceutical treatment.; * Part 2 has 9 items and a four point's response scale with response alternatives from 0 to 3: "No (0), Yes, to a certain extent (1), Yes, quite a lot (2) or Yes, a lot (3) ". A summarized score is calculated for the items, a higher score implies higher symptom burden due to the heart rhythm disturbance. Scoring for the ASTA symptom burden scale ranges from 0 (least burdensome) to highest 27 (most burdensome).; * Part 3 scale has 13 items and describes the arrhythmia's influence on daily life with a seven items physical subscale (items 1-5, 10 and 12) and a six items mental subscale (items 6-9, 11 and 13). The response alternatives from 0 to 3: "No (0), Yes, to a certain extent (1), Yes, quite a lot (2),
Change in self efficacy in medication use score as measured by the Medication Self Efficacy Tool (MUSE) survey	Baseline, 6 months	MUSE is 7 items which are evaluated to identify if the patient has a good overall understanding and perception of their medicine.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States