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Completed

NCT Number: NCT04297735

Telemedicine Enabling Patients in Self-care Behaviors

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.

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Key information

Conditions

Arrythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care group

Other

Visits every 6 months is standard of care.

Other names: Telemedicine

Telemedicine group

Behavioral

Conduct monthly telemedicine 'skype' visit

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.

Primary outcomes

  1. Time of recognition of an arrhythmia

    Time frame: Up to 6 months

    Patient recognition of a probable arrhythmia

  2. Time of diagnosis of arrhythmia

    Time frame: Up to 6 months

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

  3. Time to treatment initiation of arrhythmia

    Time frame: Up to 6 months

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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),

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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