Atrial FibrillationNCT04813094
An Integrated-management Program to Control Health-related Quality of Life Among Patients With Atrial Fibrillation
A study testing Internet-Based integrated-management Program in people with Atrial Fibrillation, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Internet-Based integrated-management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2018to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Psychiatric disorder
- Participate in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Internet-Based integrated-management Program, Control group
- Keywords
- Internet-Based, Atrial fibrillation, readmission, health-related quality of life
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based integrated-management ProgramOther
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.
Control groupOther
Patients in the control group will receive standard nurse consultations and three-time telephone coaching.
| Study group | Role | What they receive |
|---|---|---|
| Internet-Based integrated-management Program | Experimental | 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. Receives: Other: Internet-Based integrated-management Program |
| Control group | Active comparator | Patients in the control group will receive standard nurse consultations and three-time telephone coaching. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from coping strategies at 1 months, 3 months and 6 months.
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.
Measured: Change from medicine adherence at 1 months, 3 months and 6 months.
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.
Measured: Change from Health-Related Quality of Life at 1 months, 3 months and 6 months.
Secondary outcomes (1)
Readmission events
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.
Measured: Change from readmission events at after intervention within 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start2 Oct 2018
- Primary completion12 Oct 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fung-Wei Chang, Tri-Service General Hospital (TSGH)
- Investigators
- Chi-Wen Kao, PHD, Study director, Taiwan Nurses Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813094
- Sponsor's protocol ID
- Tri_20210311
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505Pistoia F, Sacco S, Tiseo C, Degan D, Ornello R, Carolei A. The Epidemiology of Atrial Fibrillation and Stroke. Cardiol Clin. 2016 May;34(2):255-68. doi: 10.1016/j.ccl.2015.12.002. Epub 2016 Mar 18.
PubMed 27150174Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
PubMed 24345399Tse HF, Wang YJ, Ahmed Ai-Abdullah M, Pizarro-Borromeo AB, Chiang CE, Krittayaphong R, Singh B, Vora A, Wang CX, Zubaid M, Clemens A, Lim P, Hu D. Stroke prevention in atrial fibrillation--an Asian stroke perspective. Heart Rhythm. 2013 Jul;10(7):1082-8. doi: 10.1016/j.hrthm.2013.03.017. Epub 2013 Mar 15.
PubMed 23501173Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.
PubMed 16818816Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013 Sep;34(35):2746-51. doi: 10.1093/eurheartj/eht280. Epub 2013 Jul 30.
PubMed 23900699Chiang CE, Wang KL, Lin SJ. Asian strategy for stroke prevention in atrial fibrillation. Europace. 2015 Oct;17 Suppl 2:ii31-9. doi: 10.1093/europace/euv231.
PubMed 26842113Chiang CE, Wu TJ, Ueng KC, Chao TF, Chang KC, Wang CC, Lin YJ, Yin WH, Kuo JY, Lin WS, Tsai CT, Liu YB, Lee KT, Lin LJ, Lin LY, Wang KL, Chen YJ, Chen MC, Cheng CC, Wen MS, Chen WJ, Chen JH, Lai WT, Chiou CW, Lin JL, Yeh SJ, Chen SA. 2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation. J Formos Med Assoc. 2016 Nov;115(11):893-952. doi: 10.1016/j.jfma.2016.10.005. Epub 2016 Nov 24.
PubMed 27890386Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
PubMed 27567408Hsieh HL, Kao CW, Cheng SM, Chang YC. A Web-Based Integrated Management Program for Improving Medication Adherence and Quality of Life, and Reducing Readmission in Patients With Atrial Fibrillation: Randomized Controlled Trial. J Med Internet Res. 2021 Sep 22;23(9):e30107. doi: 10.2196/30107.
PubMed 34550084
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04813094
- Acronym / sponsor ID
- Tri_20210311
- Conditions
- Atrial Fibrillation
- Keywords
- Internet-Based, Atrial fibrillation, readmission, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-Based integrated-management Program | Experimental | Other: Internet-Based integrated-management ProgramThe 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. |
| Control group | Active comparator | Other: Control groupPatients in the control group will receive standard nurse consultations and three-time telephone coaching. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Atrial fibrillation
- ≥20 years old
- Have a clear consciousness
- Fluent in Mandarin/Taiwanese
- Receiving anticoagulant treatment
Key exclusion criteria (2 listed)
- Psychiatric disorder
- Participate in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based integrated-management ProgramThe 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. | Other | Internet-Based integrated-management Program |
| Control groupPatients in the control group will receive standard nurse consultations and three-time telephone coaching. | Other | Control group |
Primary outcome
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.
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.
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.
1 secondary outcome
Readmission events
Time frame: Change from readmission events at after intervention within 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Results publication: PubMed 32860505Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
- Results publication: PubMed 27150174Pistoia F, Sacco S, Tiseo C, Degan D, Ornello R, Carolei A. The Epidemiology of Atrial Fibrillation and Stroke. Cardiol Clin. 2016 May;34(2):255-68. doi: 10.1016/j.ccl.2015.12.002. Epub 2016 Mar 18.
- Results publication: PubMed 24345399Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
- Results publication: PubMed 23501173Tse HF, Wang YJ, Ahmed Ai-Abdullah M, Pizarro-Borromeo AB, Chiang CE, Krittayaphong R, Singh B, Vora A, Wang CX, Zubaid M, Clemens A, Lim P, Hu D. Stroke prevention in atrial fibrillation--an Asian stroke perspective. Heart Rhythm. 2013 Jul;10(7):1082-8. doi: 10.1016/j.hrthm.2013.03.017. Epub 2013 Mar 15.
- Results publication: PubMed 16818816Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.
- Results publication: PubMed 23900699Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013 Sep;34(35):2746-51. doi: 10.1093/eurheartj/eht280. Epub 2013 Jul 30.
- Results publication: PubMed 26842113Chiang CE, Wang KL, Lin SJ. Asian strategy for stroke prevention in atrial fibrillation. Europace. 2015 Oct;17 Suppl 2:ii31-9. doi: 10.1093/europace/euv231.
- Results publication: PubMed 27890386Chiang CE, Wu TJ, Ueng KC, Chao TF, Chang KC, Wang CC, Lin YJ, Yin WH, Kuo JY, Lin WS, Tsai CT, Liu YB, Lee KT, Lin LJ, Lin LY, Wang KL, Chen YJ, Chen MC, Cheng CC, Wen MS, Chen WJ, Chen JH, Lai WT, Chiou CW, Lin JL, Yeh SJ, Chen SA. 2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation. J Formos Med Assoc. 2016 Nov;115(11):893-952. doi: 10.1016/j.jfma.2016.10.005. Epub 2016 Nov 24.
- Results publication: PubMed 27567408Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
- Derived from this study: PubMed 34550084Hsieh HL, Kao CW, Cheng SM, Chang YC. A Web-Based Integrated Management Program for Improving Medication Adherence and Quality of Life, and Reducing Readmission in Patients With Atrial Fibrillation: Randomized Controlled Trial. J Med Internet Res. 2021 Sep 22;23(9):e30107. doi: 10.2196/30107.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Wen Kao, PHD study director
Taiwan Nurses Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based integrated-management Program in people with Atrial Fibrillation, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping strategies (time frame: Change from coping strategies at 1 months, 3 months and 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813094, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.