Atrial FibrillationAMADEUSNCT03763500
Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation.
A study testing Internet-based education in people with Atrial Fibrillation and Quality of Life, run by Ulla Walfridsson at 3 sites in Sweden.
Trial summary
This study is prospective, open and randomized concerning the value of an Internet-based educational program for patients with atrial fibrillation compared to "care as usual". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Quality of Life, Signs and Symptoms
- What is being tested?
- Internet-based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesSweden
- Study dates
- 3 Dec 2018to 30 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.
Who cannot join
- Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. Insufficient knowledge of the Swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Not yet recruiting
Dept of Internal Medicine, County Hospital
Jönköping, Småland
Marija Jakovlevski Hedback, MD, +46 10241 00 00, marija.jakovlevski.hedback@rjl.se
- Recruiting
Dept of Cardiology, HMC, University Hospital
Linköping, Östergötland County, 58185
Ulla Walfridsson, RN PhD, +46 101033711, ulla.walfridsson@regionostergotland.se
Hakan Walfridsson, MD PhD, +46 101032199, hakan.walfridsson@regionostergotland.se
- Not yet recruiting
Dept of Cardiology, University Hospital
Örebro, Närke
Dritan Poci, MD PhD, +46 19602 10 00, dritan.poci@regionorebrolan.se
About this study
Official title: AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.
This study is prospective, open and randomized concerning the value of an Internet-based educational program for patients with atrial fibrillation compared to "care as usual".
Read the detailed description
In the present guidelines for treatment of atrial fibrillation education and information are underlined as important parts of the care. The investigators developed an Internet-based educational program in close collaboration with patients, specialists in the field, both physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.
The aim of the study is to evaluate this program in comparison to "care as usual" with reduction in symptom burden as primary endpoint, secondary endpoints being improvement in health-related quality of life and reduction in health-care costs.
- Being tested
- Internet-based education
- Keywords
- Atrial fibrillation, Symptom burden, Health-related quality of life, Health economy
- Medical subject headings
- Atrial Fibrillation, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based educationOther
A six-step Internet-based patient education.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation. |
| Internet-based education | Active comparator | Patients randomized in this arm receive an Internet-based educational program in addition to extended written information. This includes 6 steps with detailed information on background, symptoms, investigations, treatment options, life-style as well as one part with guides to self management. Receives: Other: Internet-based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom burden
Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
Measured: One year after randomisation
Secondary outcomes (2)
Health-related quality of life
Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
Measured: One year after randomisation
Health economy
Health-care costs during the year prior to the study and for the two arm during the study period
Measured: One year prior to and one year after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start3 Dec 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized and open study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulla Walfridsson
- Sponsor type
- Other government
- Collaborators
- Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden., Dept of Cardiology, Örebro University Hospital, Sweden
- Responsible party
- Sponsor-investigator, Ulla Walfridsson, Linkoeping University
- Investigators
- Ulla Walfridsson, RN PhD, Study chair, Dept of Cardiology, IMH, Linkoeping University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763500
- Sponsor's protocol ID
- LiU Amadeus 2018
- Acronym
- AMADEUS
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.
- ClinicalTrials.gov ID
- NCT03763500
- Acronym / sponsor ID
- AMADEUS / LiU Amadeus 2018
- Keywords
- Atrial fibrillation, Symptom burden, Health-related quality of life, Health economy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ulla WalfridssonOther government
- Collaborators
- Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden., Dept of Cardiology, Örebro University Hospital, Sweden
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 4 Dec 2018 (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.
This study is prospective, open and randomized concerning the value of an Internet-based educational program for patients with atrial fibrillation compared to "care as usual".
Detailed description
In the present guidelines for treatment of atrial fibrillation education and information are underlined as important parts of the care. The investigators developed an Internet-based educational program in close collaboration with patients, specialists in the field, both physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.
The aim of the study is to evaluate this program in comparison to "care as usual" with reduction in symptom burden as primary endpoint, secondary endpoints being improvement in health-related quality of life and reduction in health-care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized and open study
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation. |
| Internet-based education | Active comparator | Other: Internet-based educationPatients randomized in this arm receive an Internet-based educational program in addition to extended written information. This includes 6 steps with detailed information on background, symptoms, investigations, treatment options, life-style as well as one part with guides to self management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.
Key exclusion criteria (1 listed)
- Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. Insufficient knowledge of the Swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.
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 educationA six-step Internet-based patient education. | Other | Internet-based education |
Primary outcome
Symptom burden
Time frame: One year after randomisation
Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
2 secondary outcomes
Health-related quality of life
Time frame: One year after randomisation
Health economy
Time frame: One year prior to and one year after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
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.
Ulla Walfridsson, RN PhD study chair
Dept of Cardiology, IMH, Linkoeping University, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based education in people with Atrial Fibrillation and Quality of Life, run by Ulla Walfridsson at 3 sites in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulla Walfridsson, RN PhD (+46 101033711, ulla.walfridsson@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom burden (time frame: One year after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.