Myocardial InfarctionMOVE-ITNCT06085508
Fear of MOVEment After MI and AF - InterneT Patient Education
A study testing Digital patient education to reduce kinesiophobia after MI and/or AF in people with Myocardial Infarction and Atrial Fibrillation, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Atrial Fibrillation, Kinesiophobia
- What is being tested?
- Digital patient education to reduce kinesiophobia after MI and/or AF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 11 Oct 2023to 29 Feb 2024
- 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 (n=16 with MI and/or AF with kinesiophobia score of > 37.
- Recruitment: around six months after the heart event (MI and or/AF)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Anita Kärner Köhler
Norrköping, Östergötland County, 601 74
Anita Kärner Köhler, Ass. prof, +46 (0) 11363506, anita.karner@liu.se
Ghassan Mourad, Ass. prof, +46 (0) 11 363514, ghassan.mourad@liu.se
About this study
Official 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
Read more
- Can a digital patient group-education reduce kinesiophobia and promote PA in patients with MI and/or AF?
- 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.
Read the 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.
- Conditions
- Myocardial Infarction, Atrial Fibrillation, Kinesiophobia
- Being tested
- Digital patient education to reduce kinesiophobia after MI and/or AF
- Keywords
- Kinesiophobia, Myocardial infarction, Atrial fibrillation, Physical activity, Digital patient education
- Medical subject headings
- Myocardial Infarction, Atrial Fibrillation, Kinesiophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital patient education to reduce kinesiophobia after MI and/or AFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital patient education to reduce kinesiophobia | Experimental | 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. Receives: Behavioral: Digital patient education to reduce kinesiophobia after MI and/or AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, after the 8-week programme and 3 months after the programme is completed.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At baseline, after the 8-week programme and 3 months after the programme is completed.
Patients' experiences of the digital programme
Individual semi- structured interviews
Measured: After the 8-week programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start11 Oct 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Digital patient education to reduce kinesiophobia
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital, Sormland County Council, Sweden, Kalmar County Hospital, Region Östergötland
- Responsible party
- Principal investigator, Anita Karner, Linkoeping University
- Investigators
- Anita Kärner Köhler, Ass. prof, Principal investigator, Linkoping University, Dept of Health, Medicine and Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085508
- Sponsor's protocol ID
- FORSS-968769
- Other IDs
- 2023-01-20
- Acronym
- MOVE-IT
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of MOVEment After Myocardial Infarction or Atrial Fibrillation - Patient Education Via InterneT- a Pilot Study
- ClinicalTrials.gov ID
- NCT06085508
- Acronym / sponsor ID
- MOVE-IT / FORSS-968769
- Conditions
- Myocardial Infarction, Atrial Fibrillation, Kinesiophobia
- Keywords
- Kinesiophobia, Myocardial infarction, Atrial fibrillation, Physical activity, Digital patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Sahlgrenska University Hospital, Sormland County Council, Sweden, Kalmar County Hospital, Region Östergötland
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 17 Oct 2023 (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.
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
- Can a digital patient group-education reduce kinesiophobia and promote PA in patients with MI and/or AF?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Digital patient education to reduce kinesiophobia
| Arm | Type | Receives |
|---|---|---|
| Digital patient education to reduce kinesiophobia | Experimental | Behavioral: Digital patient education to reduce kinesiophobia after MI and/or AFIntervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Digital patient education to reduce kinesiophobia after MI and/or AFGroup-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. | Behavioural | Digital patient education to reduce kinesiophobia |
Primary outcome
Kinesiophobia
Time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.
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.
6 secondary outcomes
ActiGraph (accelerometer)
Time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.
Physical exercise behaviour
Time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.
Self-efficacy
Time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.
Heart focused anxiety
Time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.
Self-rated health
Time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.
Patients' experiences of the digital programme
Time frame: After the 8-week programme
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Yes. 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.
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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.
Anita Kärner Köhler, Ass. prof principal investigator
Linkoping University, Dept of Health, Medicine and Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital patient education to reduce kinesiophobia after MI and/or AF in people with Myocardial Infarction and Atrial Fibrillation, run by Linkoeping University at 1 site 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 2 inclusion and 3 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Anita Kärner Köhler, Ass. prof (+46 (0)11 363506, anita.karner@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: At baseline, after the 8-week programme and 3 months after the programme is completed.). 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 Nov 2023.