Atrial Fibrillation Clinical Trial
— MOVE-ITOfficial title:
Fear of MOVEment After Myocardial Infarction or Atrial Fibrillation - Patient Education Via InterneT- a Pilot Study
The overall aim with the project is to evaluate if a digital patient group-education can reduce kinesiophobia and promote physical activity in patients with myocardial infarction (MI) and/or atrial fibrillation (AF) Research questions 1. Can a digital patient group-education reduce kinesiophobia and promote PA in patients with MI and/or AF? 2. Is a digital patient group-education feasible based on the patients' experiences? Intervention: Patients with MI and/or AF and kinesiophobia meet 7 times in a group education via Zoom® video meetings with a tutor (nurse, physiotherapist) for 8 weeks and learn about PA, kinesiophobia, AF and/or CAD. The education involves four real life scenarios as a starting point for the learning process inspired by problem-based learning, live stream/recorded lectures/resource, behavioral activation and exposure to PA in order to reduce kinesiophobia and promote PA.
Status | Recruiting |
Enrollment | 14 |
Est. completion date | February 29, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients (n=16 with MI and/or AF with kinesiophobia score of > 37. - Recruitment: around six months after the heart event (MI and or/AF) Exclusion Criteria: - ongoing investigation of coronary artery disease and/or atrial fibrillation or other disease that results in a negative prognosis within 1 year. - patients who have difficulty participating in and cooperating with other people in groups due to, for example, mental illness, obvious abuse of alcohol or drugs, difficulties communicating or reading the Swedish language, - or participation in other studies that may affect the results are excluded. |
Country | Name | City | State |
---|---|---|---|
Sweden | Anita Kärner Köhler | Norrköping | Ostergotland |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University | Kalmar County Hospital, Region Östergötland, Sahlgrenska University Hospital, Sweden, Sormland County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinesiophobia | The Tampa Scale of Kinesiophobia - Swedish version for the heart is a scale which comprises 17 items that assess the subjective rating of kinesiophobia. Each item is rated on a 4-point Likert scale with scoring alternatives ranging from "strongly disagree" to "strongly agree". The total score varies between 17 and 68. A high value indicates a high level of kinesiophobia. A cut-off > 37 is defined as a high level of kinesiophobia. | At baseline, after the 8-week programme and 3 months after the programme is completed. | |
Secondary | ActiGraph (accelerometer) | Patient's objective physical activity during day-time for a week. An accelerometer (Actigraph) will be used to objectively assess physical activity (light (LPA), moderate-to-vigorous (MVPA)) and sedentary behaviour. Outcomes will include daily minutes of physical activity and sedentary behaviour, and the proportion and distribution of time spent in each behaviour. | At baseline, after the 8-week programme and 3 months after the programme is completed. | |
Secondary | Physical exercise behaviour | Stages of exercise behaviour change scale is a single-item five-category scale, based on the 'Stages of Change' model was used to measure the level of exercise behaviour. Respondents will be asked to mark one of five statements that most correctly described their current physical exercise level. Each statement corresponded to one of the five stages: precontemplation, contemplation, preparation, action, and maintenance represented an increased order of exercise behaviour. | At baseline, after the 8-week programme and 3 months after the programme is completed. | |
Secondary | Self-efficacy | General self-efficacy scale is a four-point Likert scale ranging from 'not at all true' (1) to 'exactly true' (4). A higher score indicates a higher GSE, which predicts the ability to cope with daily problems and the ability to adapt after experiencing various stressful life events | At baseline, after the 8-week programme and 3 months after the programme is completed. | |
Secondary | Heart focused anxiety | Cardiac Anxiety scale is a 5-point Likert scale with scores ranging from 0 (never) to 4 (always). A high score indicates a greater number of symptoms, greater frequency, or both. | At baseline, after the 8-week programme and 3 months after the programme is completed. | |
Secondary | Self-rated health | EuroQol-visual analogue scales (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. | At baseline, after the 8-week programme and 3 months after the programme is completed. | |
Secondary | Patients' experiences of the digital programme | Individual semi- structured interviews | After the 8-week programme |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |