An Integrated-management Program to Control Health-related Quality of Life Among Patients With Atrial Fibrillation

March 23, 2021 updated by: Fung-Wei Chang, Tri-Service General Hospital

An Internet-Based Integrated-management Program to Control Readmission and Health-related Quality of Life Among Patients With Atrial Fibrillation: a Randomized Controlled Trial

The aim of this study is to evaluate the effectiveness of the Internet-based integrated-management Program on increasing coping strategies, medical adherence and HRQoL, and reducing readmission in patients with atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design a double-blind two-group longitudinal experimental study will be conducted to compare the Internet-based integrated-management Program with a usual care.

After receiving informed consents, participants will be randomly assigned to two groups by using a web-based system with blocked randomization. The intervention group will receive an Internet-based integrated management Program, and control group will receive nurse consultations and three times telephone coaching. Outcomes from three self-report questionnaires at 1 month, 3 months and 6 months after initiating the intervention will be compared to baseline assessments. Outcome measurements include the following parameters: 28-item Brief COPE, Medication Adherence Rating Scale (MARS), the 3-level version of EuroQol five-dimension self-report questionnaire (EQ-5D-3L), and readmission events.

Inclusion and exclusion criteria: The inclusion criteria are: (1) those who are ≥20 years old and AF diagnosed by a cardiology specialist, (2) have clear consciousness, (3) are fluent in Mandarin/Taiwanese, (4) are receiving anticoagulant treatment, (5) are able to use mobile phone and compute. The exclusion criteria are: (1) diagnosed with any psychiatric disorder, (2) are involved in other clinical trials.

Recruitment Participants will be recruited from a cardiology outpatient clinic of a medical center in northern Taiwan. The study design and protocols had been reviewed and approved by the institutional review board of the participating hospital. At the content session, all assessments and procedures will be fully explained.

Assessment of eligibility and randomization: Participants will be considered eligible if they meet the inclusion criteria. All participants will be informed that they are able to withdraw from the study at any time. Before randomization, participants will be asked to answer four questionnaires. The questionnaires include demographic characteristics, 28-item Brief COPE, Cardiac Symptom Survey (CSS), Medication Adherence Rating Scale (MARS), and the 3-level version of EuroQol five-dimension self-report questionnaire (EQ-5D-3L).

Double blinding is maintained because i) research nurse who is involved in the collection of post-test data are not having any information of group assignment. ii) Participants do not know their group assignment and receive corresponding interventions.

The Internet-based integrated management Program is conducted in the cardiology outpatient department. Participants will have their own account and passwords to log in to the system via mobile phones or computers. The system has five domains that included patient's information collection, AF knowledge area, instructions on anticoagulation medicine, self-monitoring of symptom area, and professional consultation. Everyone has their own area to ensure the privacy of participants. The research nurse will have sent messages every day to care about the participant's condition. In this area, when the participants have an emergency, it will not only provide textual information, but also provide telephone coaching. In addition, the investigators also will instruct participants and provide the AF management manual, which will include a description of the causes and predisposing risk factors of AF, the symptoms of AF, the relationship between AF and stroke, stroke prevention measures for patients with AF, and managing a healthy lifestyle.

Patients in the control group will receive standard nurse consultations. A manual of AF management is provided and explained. In addition, the investigators will provide a three-time telephone coaching, which will teach participants how to manage their disease and associated disease knowledge at the 1 month, 3 months and 6 months after random assignment.

Coping strategies: The 28-item Brief COPE self-report questionnaire measure strategies participants use for coping. The Brief-COPE is divided into approach coping, in which individuals actively seek resources to deal with their health problems; and avoidance coping, in which individuals attempt to divert attention away from events. Higher scores indicate greater use of the specific coping strategy.

Medicine adherence: This 10-items MARS scale has three domains: medication adherence behavior, attitude toward taking medication, and negative side-effects and attitudes to medication. The total possible score ranged from 0 to 10. A higher score indicates a better medicine adherence.

Health-Related Quality of Life: Participant's HRQoL was measured by the 3-level version of EuroQol five-dimension self-report questionnaire (EQ-5D-3L). The instrument has two subscales: the EQ-5D descriptive system (5 items) and the EuroQol visual analog scale (EQ-VAS). The EQ-5D descriptive system have five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-VAS is an individual's self-assessment of health status, with a vertical scale of 20 cm (visual analog scale). The higher score indicates the best possible state of health.

Readmission events: After inclusion in the study, the investigators will follow up readmission events in all included participants. The readmission events are based on the query of medical records in the research hospital.

Statistical analysis: the investigators will use descriptive statistics (mean, standard deviation, frequency and percentage) to analyze participant characteristics and outcomes. The initial differences between groups for demographic characteristics, coping strategies, medical adherence, and HRQoL will be examined with independent t-tests and Chi-square analysis. Effects of the Internet-based integrated-management Program on coping strategies, medical adherence, and HRQoL in patients with AF will be analyze using generalized estimating equations (GEE). The significance will be defined as a two-tailed P-value of < 0.05.

Patient's characteristics will report as age, gender, type of AF, the class of mEHRA, comorbidities and medication status are evaluated by the univariate logistic regression to assess the association with the readmission events. Predictor variables with P value <0.20 are eligible for inclusion in the multivariable logistic regression model for the outcome. The continuous variables are converted to categorical variables in the multivariable logistic model. In the multivariable logistic regression model, predictor variables with two-tailed P value <0.05 are considered significant.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu
      • Taipei, Neihu, Taiwan, 11490
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnosis of Atrial fibrillation
  2. ≥20 years old
  3. Have a clear consciousness
  4. Fluent in Mandarin/Taiwanese
  5. Receiving anticoagulant treatment
  6. Able to use mobile phones and computers.

Exclusion Criteria:

  1. Psychiatric disorder
  2. Participate in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Internet-Based integrated-management Program
The Internet-based integrated management Program system have five domains that included patient's information collection, AF knowledge area, instructions on anticoagulation medicine, self-monitoring of symptom area, and professional consultation. Participants will have their own account and passwords to log in to the system via mobile phones or computers. Everyone will have their own area to ensure the privacy of participants. The research nurse will have sent messages every day to care about the participant's condition.
Other: Internet-Based integrated-management Program
The Internet-based integrated management Program system have five domains that included patient's information collection, AF knowledge area, instructions on anticoagulation medicine, self-monitoring of symptom area, and professional consultation. Everyone have their own area to ensure the privacy of participants. The research nurse has sent messages every day to care about the participant's condition. In this area, when the participant have an emergency, it not only provided textual information, but also provided telephone coaching.
ACTIVE_COMPARATOR: Control group
Patients in the control group will receive standard nurse consultations and three-time telephone coaching.
Other: Control group
Patients in the control group will receive standard nurse consultations and three-time telephone coaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping strategies
Time Frame: Change from coping strategies at 1 months, 3 months and 6 months.
The 28-item Brief COPE self-report questionnaire measure strategies participants use for coping. The Brief-COPE is divided into approach coping, in which individuals actively seek resources to deal with their health problems; and avoidance coping, in which individuals attempt to divert attention away from events. Higher scores indicate greater use of the specific coping strategy.
Change from coping strategies at 1 months, 3 months and 6 months.
Medicine adherence
Time Frame: Change from medicine adherence at 1 months, 3 months and 6 months.
This 10-items MARS scale has three domains: medication adherence behavior, attitude toward taking medication, and negative side-effects and attitudes to medication. The total possible score ranged from 0 to 10. A higher score indicates a better medicine adherence.
Change from medicine adherence at 1 months, 3 months and 6 months.
Health-Related Quality of Life
Time Frame: Change from Health-Related Quality of Life at 1 months, 3 months and 6 months.
Participant's HRQoL was measured by the 3-level version of EuroQol five-dimension self-report questionnaire (EQ-5D-3L). The instrument has two subscales: the EQ-5D descriptive system (5 items) and the EuroQol visual analog scale (EQ-VAS). The EQ-5D descriptive system have five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-VAS is an individual's self-assessment of health status, with a vertical scale of 20 cm (visual analog scale). The higher score indicates the best possible state of health.
Change from Health-Related Quality of Life at 1 months, 3 months and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission events
Time Frame: Change from readmission events at after intervention within 2 years.
After inclusion in the study, we will follow up readmission events in all included participants. The readmission events are based on the query of medical records in the research hospital.
Change from readmission events at after intervention within 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Study Director: Chi-Wen Kao, PHD, Taiwan Nurses Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2018

Primary Completion (ACTUAL)

October 12, 2020

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tri_20210311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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