Clinical trial NCT04813094: An Integrated-management Program to Control Health-related Quality of Life Among Patients With Atrial Fibrillation
Official title: An Internet-Based Integrated-management Program to Control Readmission and Health-related Quality of Life Among Patients With Atrial Fibrillation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Internet-Based
Atrial fibrillation
readmission
health-related quality of life
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 232
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coping strategies
timeFrame: Change from coping strategies at 1 months, 3 months and 6 months.
measure: Medicine adherence
timeFrame: Change from medicine adherence at 1 months, 3 months and 6 months.
measure: Health-Related Quality of Life
timeFrame: Change from Health-Related Quality of Life at 1 months, 3 months and 6 months.
Secondary outcomes:
measure: Readmission events
timeFrame: Change from readmission events at after intervention within 2 years.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Neihu
Study officials:
affiliation: Taiwan Nurses Association
name: Chi-Wen Kao, PHD
role: STUDY_DIRECTOR
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