Clinical trial NCT06085508: Fear of MOVEment After MI and AF - InterneT Patient Education
Official title: Fear of MOVEment After Myocardial Infarction or Atrial Fibrillation - Patient Education Via InterneT- a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Atrial Fibrillation
Kinesiophobia
Keywords: Kinesiophobia
Myocardial infarction
Atrial fibrillation
Physical activity
Digital patient education
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Sahlgrenska University Hospital
name: Sormland County Council, Sweden
name: Kalmar County Hospital
name: Region Östergötland
First posted: 2023-10-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Digital patient education to reduce kinesiophobia
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Patients with myocardial infarction (MI) and/or atrial fibrillation (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 physical activity (PA), kinesiophobia, AF and/or MI. The education involves four real life scenarios as a starting point for the learning process inspired by problem-based learning (PBL) live stream/recorded lectures/resources and exposure to PA to reduce kinesiophobia and promote PA.

Intervention: Digital fear of movement programme:

Week 1: Introduction of programme Aim: Patients reflect on expectations of the program and formulate individual goals. Home assignment: Watch digital lecture about PA after MI/AF and SMART Goals.

Week 2: Start Scenario 1: Why PA after MI/AF? Aim: Patients reflect on pros and cons of PA. Discuss lectures watched. Group thoughts and reflections and formulate questions to be answered next meeting (home assignment).

Week 3: Scenario 2: What is MI/AF. Follow-up scenario 1: How does the knowledge affect me. Aim: To reflect on PA and MI/AF. Start scenario 2: Think free and group thoughts and reflections about PA and formulate questions to be answered next meeting (home assignment).

Week 4: Scenario 3: Living with MI/AF and kinesiophobia - How to make a change? Follow-up scenario 2: How does the knowledge affect me. Aim: to identify and become aware of how thoughts affect PA in his/her life. Start scenario 3: Think free and group thoughts and reflections about living with MI/AF and kinesiophobia - How to make a change and formulate questions to be answered next meeting (home assignment). Home assignment: Map activities in a weekly schedule, rate activities as frightening/non-frightening. Make a list of desirable PA and choose one activity to implement. Use SMART GOALS. Watch digital lecture about: Fear avoidance model.

Week 5: Scenario 4: How can I reduce my fear for PA. Follow-up scenario 3: How does the knowledge affect me. Aim: To implement change. Start scenario 4: Think free and group thoughts and reflections about how can I reduce my fear for PA? SMART, the planned activity Week 6: Follow-up scenario 4. Discuss perception and the performance of the activity. What experiences will I take with me in future activities. Discuss how to continue with the activity plan. Aim: To implement change.

Week 7: Own individual work Use documents to plan desirable activity/ies Aim: To enable change. To become aware of and reflect on how thoughts, moods and fears affect his/her life and performance of PA. Home assignment: Evaluate activity plan and revise and perform desired activities.

Week 8: Follow-up of the activity plan of the program. Summarize and discuss the program. Create a plan for maintenance. Aim: To summarize the program and facilitate maintenance of the changes in PA. Create a checklist for coping with future setbacks, identifying tools perceived as helpful by the participant.

Eligibility criteria: 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.

Primary outcomes:
measure: Kinesiophobia
timeFrame: At baseline, after the 8-week programme and 3 months after the programme is completed.
Secondary outcomes:
measure: ActiGraph (accelerometer)
timeFrame: At baseline, after the 8-week programme and 3 months after the programme is completed.
measure: Physical exercise behaviour
timeFrame: At baseline, after the 8-week programme and 3 months after the programme is completed.
measure: Self-efficacy
timeFrame: At baseline, after the 8-week programme and 3 months after the programme is completed.
measure: Heart focused anxiety
timeFrame: At baseline, after the 8-week programme and 3 months after the programme is completed.
measure: Self-rated health
timeFrame: At baseline, after the 8-week programme and 3 months after the programme is completed.
measure: Patients' experiences of the digital programme
timeFrame: After the 8-week programme
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Anita Kärner Köhler
state: Ostergotland
Study officials:
affiliation: Linkoping University, Dept of Health, Medicine and Care
name: Anita Kärner Köhler, Ass. prof
role: PRINCIPAL_INVESTIGATOR
References: