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

Primary Purpose

Digital Patient- Group Education, Kinesiophobia, Physical Activity, Myocardial Infarction, Atrial Fibrillation

Status
Recruiting
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Digital patient education to reduce kinesiophobia after MI and/or AF
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Digital Patient- Group Education, Kinesiophobia, Physical Activity, Myocardial Infarction, Atrial Fibrillation focused on measuring Kinesiophobia, myocardial infarction, atrial fibrillation, physical activity, digital patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anita Kärner KöhlerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digital patient education to reduce kinesiophobia

Arm Description

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.

Outcomes

Primary Outcome Measures

Kinesiophobia
The Tampa Scale of Kinesiophobia Swedish Version for the Heart

Secondary Outcome Measures

ActiGraph (accelerometer)
Patient's objective physical activity during day-time for a week
Physical exercise behaviour
Stages of exercise behaviour change scale
Self-efficacy
General self-efficacy scale
Heart focused anxiety
Cardiac Anxiety scale
Self-rated health
EQ-VAS
Patients' experiences of the digital programme
Individual semi- structured interviews

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Linkoeping University
Collaborators
Sahlgrenska University Hospital, Sweden, Sormland County Council, Sweden, Kalmar County Hospital, Region Östergötland
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1. Study Identification

Unique Protocol Identification Number
NCT06085508
Brief Title
Fear of MOVEment After MI and AF - InterneT Patient Education
Acronym
MOVE-IT
Official Title
Fear of MOVEment After Myocardial Infarction or Atrial Fibrillation - Patient Education Via InterneT- a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Sahlgrenska University Hospital, Sweden, Sormland County Council, Sweden, Kalmar County Hospital, Region Östergötland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digital Patient- Group Education, Kinesiophobia, Physical Activity, Myocardial Infarction, Atrial Fibrillation
Keywords
Kinesiophobia, myocardial infarction, atrial fibrillation, physical activity, digital patient education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Digital patient education to reduce kinesiophobia
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital patient education to reduce kinesiophobia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital patient education to reduce kinesiophobia after MI and/or AF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kinesiophobia
Description
The Tampa Scale of Kinesiophobia Swedish Version for the Heart
Time Frame
At baseline, after the 8-week programme and 3 months after the programme is completed.
Secondary Outcome Measure Information:
Title
ActiGraph (accelerometer)
Description
Patient's objective physical activity during day-time for a week
Time Frame
At baseline, after the 8-week programme and 3 months after the programme is completed.
Title
Physical exercise behaviour
Description
Stages of exercise behaviour change scale
Time Frame
At baseline, after the 8-week programme and 3 months after the programme is completed.
Title
Self-efficacy
Description
General self-efficacy scale
Time Frame
At baseline, after the 8-week programme and 3 months after the programme is completed.
Title
Heart focused anxiety
Description
Cardiac Anxiety scale
Time Frame
At baseline, after the 8-week programme and 3 months after the programme is completed.
Title
Self-rated health
Description
EQ-VAS
Time Frame
At baseline, after the 8-week programme and 3 months after the programme is completed.
Title
Patients' experiences of the digital programme
Description
Individual semi- structured interviews
Time Frame
After the 8-week programme

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients are asked to state their gender identity
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anita Kärner Köhler, Ass. professor
Phone
+46 (0)11 363506
Email
anita.karner@liu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ghassan Mourad, Ass. professor
Phone
+46 (0)11 363514
Email
ghassan.mourad@liu.se
Facility Information:
Facility Name
Anita Kärner Köhler
City
Norrköping
State/Province
Ostergotland
ZIP/Postal Code
601 74
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Kärner Köhler, Associate professor
Phone
+46 (0) 11363506
Email
anita.karner@liu.se
First Name & Middle Initial & Last Name & Degree
Ghassan Mourad, Associate professor
Phone
+46 (0) 11 363514
Email
ghassan.mourad@liu.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Fear of MOVEment After MI and AF - InterneT Patient Education

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