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Virtual 360°-Tour in Coronary Computed Tomography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677791
Recruitment Status : Enrolling by invitation
First Posted : September 19, 2018
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu

Brief Summary:
The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and adherence to treatment of the patients coming to CCTA (coronary computed tomography angiography). The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Anxiety Fear Other: Virtual tour in coronary computed tomography - 360° counselling environment Other: Current practice Not Applicable

Detailed Description:

The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and adherence to treatment of the patients coming to CCTA (coronary computed tomography angiography).

The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway. Patients who have referred first time to the coronary computed tomography can access the virtual CT examination environment via link before entering the hospital. Using the environment requires a network connection and is possible with a computer, tablet or phone. The environment has digital counselling materials in text, image, animation and video formats in three different virtual spaces/views, the environment and examination are presented via pathway of example 59-year female patient with arterial hypertension and exercise related chest pain (angina pectoris).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT (Randomized controlled trial)
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: Virtual 360°-Tour in Coronary Computed Tomography - Effects of 360° Virtual Counselling Environment in CCTA Patient's Anxiety and Adherence to Treatment
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety CT Scans

Arm Intervention/treatment
Experimental: Virtual 360° intervention
counselling in the virtual 360° environment and also counselling in accordance with current practice
Other: Virtual tour in coronary computed tomography - 360° counselling environment
Virtual tour in coronary computed tomography - 360° counselling environment for CCTA patients

Active Comparator: Control group
counselling in accordance with current practice
Other: Current practice
counselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination




Primary Outcome Measures :
  1. anxiety measured with State-Trait Anxiety Inventory for adults (STAI) [ Time Frame: 1 month ]
    The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberger and his research team (1983). It separates situation related anxiety (STATE-A) from character related tendency towards anxiety (TRAIT-A). User evaluates his own current anxiety on a four-step scale with forty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety. Scores range from 20 to 80: mild anxiety 20-39 points, moderate anxiety 40-59 points and strong anxiety 60-80 points.


Secondary Outcome Measures :
  1. adherence to coronary artery disease (CAD) treatment measured with Adherence of People with Chronic Disease Instrument (ACDI) [ Time Frame: 12 months ]
    ACDI (Adherence of People with Chronic Disease Instrument) meter is self-reported adult adherence to treatment meter developed by Helvi Kyngäs (1999). It's suitable for assessment and monitoring of adherence to treatment in nursing and clinical trials. The meter's 40 questions measure the adherence to treatment on a five-point Likert scale. The instrument consists of 13 demographic data questions and 33 items on the following topics: adherence (medical care, responsibility, care planning and carrying out the care), and factors connected to adherence (support from physicians and nurses, sense of normality, support from relatives and friends, motivation and energy, consequences of treatments and fear of vision loss).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • coming to first coronary computed tomography examination
  • adult patient
  • able to independently fill in question forms

Exclusion Criteria:

  • previous coronary computed tomography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677791


Locations
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Finland
Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Additional Information:
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03677791    
Other Study ID Numbers: KPP12345
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oulu:
counselling
computed tomography
coronary
CT
virtual
360
anxiety
Additional relevant MeSH terms:
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Coronary Artery Disease
Anxiety Disorders
Mental Disorders
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases