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Telemedicine Enabling Patients in Self-care Behaviors

Telemedicine Enabling Patients in Self-care Behaviors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04297735
Enrollment
60
Registered
2020-03-05
Start date
2020-02-26
Completion date
2021-09-20
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia

Keywords

telemedicine, self-care

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

Interventions

Visits every 6 months is standard of care.

Conduct monthly telemedicine 'skype' visit

BEHAVIORALTelemedicine

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

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time of recognition of an arrhythmiaUp to 6 monthsPatient recognition of a probable arrhythmia
Time of diagnosis of arrhythmiaUp to 6 monthsTime of diagnosis of arrhythmia by medical staff- at what point is the diagnosis present.
Time to treatment initiation of arrhythmiaUp to 6 monthsThe time- what point in time is the treatment plan innitiated

Secondary

MeasureTime frameDescription
Change in self efficacy in medication use score as measured by the Medication Self Efficacy Tool (MUSE) surveyBaseline, 6 monthsMUSE is 7 items which are evaluated to identify if the patient has a good overall understanding and perception of their medicine.
Change in functioning self efficacy score as measured by the 13 Item Shortened Function Self-efficacy Scale (FSES)Baseline, 6 monthsThe 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) surveyBaseline, 6 monthsThe 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),

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026