Fear of MOVEment After MI and AF - InterneT Patient Education (MOVE-IT)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Atrial Fibrillation; Kinesiophobia
• Intervention / Treatment: Behavioral: Digital patient education to reduce kinesiophobia after MI and/or AF

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anita Kärner Köhler, Ass. prof; Phone Number: +46 (0)11 363506; Email: anita.karner@liu.se
• Study Contact Backup: Name: Ghassan Mourad, Ass. prof; Phone Number: +46 (0)11 363514; Email: ghassan.mourad@liu.se

Study Locations

• Sweden
  • Ostergotland
    • Norrköping, Ostergotland, Sweden, 601 74
      • Recruiting
      • Anita Kärner Köhler
      • Contact: Anita Kärner Köhler, Ass. prof; Phone Number: +46 (0) 11363506; Email: anita.karner@liu.se
      • Contact: Ghassan Mourad, Ass. prof; Phone Number: +46 (0) 11 363514; Email: ghassan.mourad@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digital patient education to reduce kinesiophobia; 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.

Behavioral: Digital patient education to reduce kinesiophobia after MI and/or AF; Group-meetings 7 times via Zoom® video with a tutor (nurse, physiotherapist) and learn about PA, kinesiophobia, AF and/or MI. Scenarios start the problem-based learning process involving recorded lectures, behavioral activation, and exposure to PA. Week1: Programme intro. Formulation of individual goals. Home assignment (HA): Lecture PA after MI/AF. Week 2. Discuss HA. Scenario 1: Why PA after MI/AF? (PBL) Formulate questions*. HA: Answer the questions. Week 3. Follow-up HA. Scenario 2. What is MI/AF.* Week 4. Discuss HA. Scenario 3. Living with MI/AF and kinesiophobia - How to make a change?* HA: Map weekly activities, rate as frightening/non-frightening. List PA and choose one to implement. Use SMART GOALS. Lecture: Kinesiophobia. Week 5. Discuss HA. Scenario 4. How can I reduce my fear for PA.* SMART, the activity. Week 6. Discuss HA. Week 7. Own individual work. HA: Evaluate, revise, and perform activities. Week 8. Follow-up of the activity plan. Summarize the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' experiences of the digital programme	Individual semi- structured interviews	After the 8-week programme
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Sahlgrenska University Hospital, Sweden; Region Östergötland; Kalmar County Hospital; Sormland County Council, Sweden
• Investigators: Principal Investigator: Anita Kärner Köhler, Ass. prof, Linkoping University, Dept of Health, Medicine and Care

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Myocardial infarction; Physical activity; Kinesiophobia; Digital patient education
• Additional Relevant MeSH Terms: Mental Disorders; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Anxiety Disorders; Arrhythmias, Cardiac; Phobic Disorders; Myocardial Infarction; Infarction; Atrial Fibrillation; Kinesiophobia
• Other Study ID Numbers: FORSS-968769; 2023-01-20 (Other Grant/Funding Number: The focus area E-Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Maria Bäck at Sahlgrenska University manage the data collection, analysis of the accelerometers together with Charlotta Lans at Kalmar hospital County.

The whole research group will take part in analyzing the questionnaires.

Part of the research group will analyze the transcriptions of the semistructured interviews.

• IPD Sharing Time Frame: We plan to have all data collected in February 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No