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Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Interactive 3D visualization technique
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Validity, Reliability, Rehabilitation, Translation, Education

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
  • Stadium II-IV of COPD
  • Must be able to comprehend the Swedish language

Exclusion Criteria:

  • Not diagnosed with COPD
  • Does not understand written and verbal Swedish

Sites / Locations

  • Department of physiotherapy, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interactive 3D visualization technique

Conventional technique

Arm Description

The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with 3D technique. Patients randomized into education by 3D technique.

The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with conventional technique. Patients randomized into education by conventional technique.

Outcomes

Primary Outcome Measures

Improved health related quality of life
COPD Assessment Test

Secondary Outcome Measures

Improved health related quality of life
S:t George´s Respiratory Questionnaire
Improved health related quality of life
Leicester Cough Questionnaire
Improved exercise self efficacy
SCI Exercise Self Efficacy Scale (SCI=Spinal Cord Injury)
Improved physical performance
JAMAR Hydraulic Hand Dynamometer
Improved physical performance
6 minute walk test
Attendance to rehabilitation programme
Attendance record
Improved knowledge of content in rehabilitation programme
Questionaire
Compliance to treatment
Single question about compliance to treatment
Compliance to physical activity
Single question about compliance to physical activity
Visits to hospital, primary care
Single question about number of visits to hospital and primary care
Motivation with rehabilitation programme
Visual analog scale, focus group interview
Stimulation with the of rehabilitation programme
Visual analog scale, focus group interview

Full Information

First Posted
May 27, 2016
Last Updated
February 19, 2020
Sponsor
Karolinska University Hospital
Collaborators
The Swedish Heart and Lung Association, Landstingens Ömsesidiga Försäkringsbolag (Löf), Flemingsberg Science, The Mats Kleberg Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02802618
Brief Title
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD
Official Title
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
The Swedish Heart and Lung Association, Landstingens Ömsesidiga Försäkringsbolag (Löf), Flemingsberg Science, The Mats Kleberg Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL The purpose of this study was therefore to develop a pulmonary educational program in interactive 3D visualization technology and to evaluate differences between education with 3D technique or conventional technique in patient with COPD. Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is one of the major health scourges. In 2002 COPD was the fifth leading cause of death and estimates show that COPD becomes in 2030 the third leading cause of death worldwide. The dominant cause of COPD is tobacco smoking. COPD now affects men and women almost equally. The most common symptoms of COPD are breathlessness, excessive sputum production, and a chronic cough which causes decrease in health related quality of life (HRQL). Dyspnea and movement limitations are also common symptoms in patients with COPD and this often leads to reduced levels of physical activity, physical capacity and HRQL. The Leicester Cough Questionnaire (LCQ) is a valid evaluation tool for HRQL in patients with chronic cough. Currently no specific cough questionnaire exists in Swedish. Pulmonary rehabilitation including education and exercise training improves health. The Physiotherapy department has conducted rehabilitation programs for patients with COPD since 1995. The COPD-program has several times been updated according to existing evidence. Education in anatomy, physiology, physical therapy and self-training is a big part of the physical therapist's workday. The education imparts complex knowledge. It is demanding to mediate this as education is expected to raise the patient's desire to understand, create opportunities to understand and leave a lasting impression. In effective learning repetition, own search for information, stimulation, emotional impact and experience are important factors. Information technology is developing rapidly and patient's use of this technology is increasing. It is therefore essential that education is adapted to new requirements. Interactive 3 dimensional (3D) visualization techniques can be used to represent the human body. Interactive 3D technique used in patient education has not yet been studied. A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL In the current study it will be investigated whether och not there are differences between pulmonary educational program in interactive 3D visualization technology and in conventional technique in patients with COPD. Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Validity, Reliability, Rehabilitation, Translation, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interactive 3D visualization technique
Arm Type
Experimental
Arm Description
The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with 3D technique. Patients randomized into education by 3D technique.
Arm Title
Conventional technique
Arm Type
No Intervention
Arm Description
The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with conventional technique. Patients randomized into education by conventional technique.
Intervention Type
Other
Intervention Name(s)
Interactive 3D visualization technique
Intervention Description
The pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.
Primary Outcome Measure Information:
Title
Improved health related quality of life
Description
COPD Assessment Test
Time Frame
Change from Baseline health related quality of life at 10 weeks
Secondary Outcome Measure Information:
Title
Improved health related quality of life
Description
S:t George´s Respiratory Questionnaire
Time Frame
Change from Baseline health related quality of life at 10 weeks
Title
Improved health related quality of life
Description
Leicester Cough Questionnaire
Time Frame
Change from Baseline health related quality of life at 2 and 10 weeks
Title
Improved exercise self efficacy
Description
SCI Exercise Self Efficacy Scale (SCI=Spinal Cord Injury)
Time Frame
Change from Baseline exercise self efficacy at 10 weeks
Title
Improved physical performance
Description
JAMAR Hydraulic Hand Dynamometer
Time Frame
Change from Baseline physical performance at 10 weeks
Title
Improved physical performance
Description
6 minute walk test
Time Frame
Change from Baseline physical performance at 10 weeks
Title
Attendance to rehabilitation programme
Description
Attendance record
Time Frame
10 weeks
Title
Improved knowledge of content in rehabilitation programme
Description
Questionaire
Time Frame
Change from Baseline knowledge of content in rehabilitation programme at 6 months
Title
Compliance to treatment
Description
Single question about compliance to treatment
Time Frame
6 months
Title
Compliance to physical activity
Description
Single question about compliance to physical activity
Time Frame
6 months
Title
Visits to hospital, primary care
Description
Single question about number of visits to hospital and primary care
Time Frame
6 months
Title
Motivation with rehabilitation programme
Description
Visual analog scale, focus group interview
Time Frame
6 months
Title
Stimulation with the of rehabilitation programme
Description
Visual analog scale, focus group interview
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of chronic obstructive pulmonary disease (COPD) Stadium II-IV of COPD Must be able to comprehend the Swedish language Exclusion Criteria: Not diagnosed with COPD Does not understand written and verbal Swedish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrika Einarsson, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of physiotherapy, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD

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