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

Sponsor
Linkoeping University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06085508
Collaborator
Sahlgrenska University Hospital, Sweden (Other), Sormland County Council, Sweden (Other), Kalmar County Hospital (Other), Region Östergötland (Other)
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Study Details

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

  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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital patient education to reduce kinesiophobia after MI and/or AF
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Digital patient education to reduce kinesiophobiaDigital patient education to reduce kinesiophobia
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Fear of MOVEment After Myocardial Infarction or Atrial Fibrillation - Patient Education Via InterneT- a Pilot Study
Actual Study Start Date :
Oct 11, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Feb 29, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Kinesiophobia [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

Secondary Outcome Measures

  1. ActiGraph (accelerometer) [At baseline, after the 8-week programme and 3 months after the programme is completed.]

    Patient's objective physical activity during day-time for a week

  2. Physical exercise behaviour [At baseline, after the 8-week programme and 3 months after the programme is completed.]

    Stages of exercise behaviour change scale

  3. Self-efficacy [At baseline, after the 8-week programme and 3 months after the programme is completed.]

    General self-efficacy scale

  4. Heart focused anxiety [At baseline, after the 8-week programme and 3 months after the programme is completed.]

    Cardiac Anxiety scale

  5. Self-rated health [At baseline, after the 8-week programme and 3 months after the programme is completed.]

    EQ-VAS

  6. Patients' experiences of the digital programme [After the 8-week programme]

    Individual semi- structured interviews

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anita Kärner Köhler Norrköping Ostergotland Sweden 601 74

Sponsors and Collaborators

  • Linkoeping University
  • Sahlgrenska University Hospital, Sweden
  • Sormland County Council, Sweden
  • Kalmar County Hospital
  • Region Östergötland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anita Karner, Associate professor, Linkoeping University
ClinicalTrials.gov Identifier:
NCT06085508
Other Study ID Numbers:
  • FORSS-968769
  • 2023-01-20
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anita Karner, Associate professor, Linkoeping University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023