An Internet-Based Integrated-management Program to Control Readmission and Health-related Quality of Life Among Patients With Atrial Fibrillation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Coping strategies
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Atrial fibrillation
- •≥20 years old
- •Have a clear consciousness
- •Fluent in Mandarin/Taiwanese
- •Receiving anticoagulant treatment
- •Able to use mobile phones and computers.
排除标准
- •Psychiatric disorder
- •Participate in other clinical trials.
研究组 & 干预措施
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.
干预措施: Internet-Based integrated-management Program (Other)
Control group
Patients in the control group will receive standard nurse consultations and three-time telephone coaching.
干预措施: Control group (Other)
结局指标
主要结局
Coping strategies
时间窗: 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.
Medicine adherence
时间窗: 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.
Health-Related Quality of Life
时间窗: 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.
次要结局
- Readmission events(Change from readmission events at after intervention within 2 years.)
研究者
Fung-Wei Chang
Director, Head of Obstetrics and Gynecology, Clinical Professor
Tri-Service General Hospital