NCT06085508

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. 1.Can a digital patient group-education reduce kinesiophobia and promote PA in patients with MI and/or AF?
  2. 2.Is a digital patient group-education feasible based on the patients' experiences?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 10, 2023

Last Update Submit

October 31, 2023

Conditions

Myocardial InfarctionAtrial FibrillationKinesiophobia

Keywords

KinesiophobiaMyocardial infarctionAtrial fibrillationPhysical activityDigital patient education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • ActiGraph (accelerometer)

    At baseline, after the 8-week programme and 3 months after the programme is completed.

  • Physical exercise behaviour

    At baseline, after the 8-week programme and 3 months after the programme is completed.

  • Self-efficacy

    At baseline, after the 8-week programme and 3 months after the programme is completed.

  • Heart focused anxiety

    At baseline, after the 8-week programme and 3 months after the programme is completed.

  • Self-rated health

    At baseline, after the 8-week programme and 3 months after the programme is completed.

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Digital patient education to reduce kinesiophobia after MI and/or AF

Interventions

Digital patient education to reduce kinesiophobia after MI and/or AFBEHAVIORAL

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.

Digital patient education to reduce kinesiophobia

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatients are asked to state their gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anita Kärner Köhler

Norrköping, Östergötland County, 601 74, Sweden

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionAtrial FibrillationKinesiophobiaMotor Activity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, CardiacPhobic DisordersAnxiety DisordersMental DisordersBehavior

Study Officials

  • Anita Kärner Köhler, Ass. prof

    Linkoping University, Dept of Health, Medicine and Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Kärner Köhler, Ass. prof

CONTACT

+46 (0)11 363506anita.karner@liu.se

Ghassan Mourad, Ass. prof

CONTACT

+46 (0)11 363514ghassan.mourad@liu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Digital patient education to reduce kinesiophobia
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 17, 2023

Study Start

October 11, 2023

Primary Completion

January 31, 2024

Study Completion

February 29, 2024

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
We plan to have all data collected in February 2024

Locations

SE(1)