Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04813094
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2021-03-11
Brief Title:
An Integrated-management Program to Control Health-related Quality of Life Among Patients With Atrial Fibrillation
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MandarinTaiwanese 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 patients 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 participants 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 Participants 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 paindiscomfort and anxietydepression EQ-VAS is an individuals 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 005
Patients 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 020 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 005 are considered significant
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 MandarinTaiwanese 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 patients 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 participants 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 Participants 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 paindiscomfort and anxietydepression EQ-VAS is an individuals 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 005
Patients 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 020 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 005 are considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None