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Telemedicine Enabling Patients in Self-care Behaviors

Primary Purpose

Arrythmia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard of care group

Telemedicine group

Telemedicine

About this trial

This is an interventional health services research trial for Arrythmia focused on measuring telemedicine, self-care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care group

Telemedicine group

Arm Description

Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months

Outcomes

Primary Outcome Measures

Time of recognition of an arrhythmia

Patient recognition of a probable arrhythmia

Time of diagnosis of arrhythmia

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

Time to treatment initiation of arrhythmia

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

Secondary Outcome Measures

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.

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.

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),

Full Information

NCT ID

NCT04297735

First Posted

February 28, 2020

Last Updated

September 21, 2021

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT04297735

Brief Title

Telemedicine Enabling Patients in Self-care Behaviors

Official Title

Telemedicine Enabling Patients in Self-care Behaviors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

February 26, 2020 (Actual)

Primary Completion Date

August 10, 2021 (Actual)

Study Completion Date

September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrythmia

Keywords

telemedicine, self-care

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care group

Arm Type

Active Comparator

Arm Description

Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months

Arm Title

Telemedicine group

Arm Type

Experimental

Arm Description

Discuss new arrhythmias, review symptoms, discuss methods to help symptoms, questions and answers, monitor devices every 3 months

Intervention Type

Other

Intervention Name(s)

Standard of care group

Other Intervention Name(s)

Telemedicine

Intervention Description

Visits every 6 months is standard of care.

Intervention Type

Behavioral

Intervention Name(s)

Telemedicine group

Intervention Description

Conduct monthly telemedicine 'skype' visit

Intervention Type

Behavioral

Intervention Name(s)

Telemedicine

Intervention Description

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 Outcome Measure Information:

Title

Time of recognition of an arrhythmia

Description

Patient recognition of a probable arrhythmia

Time Frame

Up to 6 months

Title

Time of diagnosis of arrhythmia

Description

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

Time Frame

Up to 6 months

Title

Time to treatment initiation of arrhythmia

Description

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

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

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

Description

MUSE is 7 items which are evaluated to identify if the patient has a good overall understanding and perception of their medicine.

Time Frame

Baseline, 6 months

Title

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

Description

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.

Time Frame

Baseline, 6 months

Title

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

Description

Time Frame

Baseline, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Fasing

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hakan Oral, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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Citation

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Telemedicine Enabling Patients in Self-care Behaviors

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