Telemedicine Enabling Patients in Self-care Behaviors

Study Overview
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Brief Summary
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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
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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

Official Title
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Telemedicine Enabling Patients in Self-care Behaviors

Conditions
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Arrythmia

Intervention / Treatment
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* Other: Standard of care group
* Behavioral: Telemedicine group
* Behavioral: Telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care group<br>Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months | Other: Standard of care group<br>* Visits every 6 months is standard of care.<br>* Other names: Telemedicine;|
| Experimental: Telemedicine group<br>Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months | Behavioral: Telemedicine group<br>* Conduct monthly telemedicine 'skype' visit<br>Behavioral: Telemedicine<br>* Review details of medication indication and use, activity recommendations and changes, and knowledge of arrhythmia changes and activities which are helpful with arrhythmia changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self efficacy in medication use score as measured by the Medication Self Efficacy Tool (MUSE) survey | MUSE is 7 items which are evaluated to identify if the patient has a good overall understanding and perception of their medicine. | Baseline, 6 months | 
| Change in functioning self efficacy score as measured by the 13 Item Shortened Function Self-efficacy Scale (FSES) | 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. | Baseline, 6 months | 
| Change in self-efficacy of arrhythmia management score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA) survey | 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), | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, self-care