- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02802618
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden, 14186
- Department of physiotherapy, Karolinska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interactive 3D visualization technique
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 two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.
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No Intervention: Conventional 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved health related quality of life
Time Frame: Change from Baseline health related quality of life at 10 weeks
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COPD Assessment Test
|
Change from Baseline health related quality of life at 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved health related quality of life
Time Frame: Change from Baseline health related quality of life at 10 weeks
|
S:t George´s Respiratory Questionnaire
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Change from Baseline health related quality of life at 10 weeks
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Improved health related quality of life
Time Frame: Change from Baseline health related quality of life at 2 and 10 weeks
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Leicester Cough Questionnaire
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Change from Baseline health related quality of life at 2 and 10 weeks
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Improved exercise self efficacy
Time Frame: Change from Baseline exercise self efficacy at 10 weeks
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SCI Exercise Self Efficacy Scale (SCI=Spinal Cord Injury)
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Change from Baseline exercise self efficacy at 10 weeks
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Improved physical performance
Time Frame: Change from Baseline physical performance at 10 weeks
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JAMAR Hydraulic Hand Dynamometer
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Change from Baseline physical performance at 10 weeks
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Improved physical performance
Time Frame: Change from Baseline physical performance at 10 weeks
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6 minute walk test
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Change from Baseline physical performance at 10 weeks
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Attendance to rehabilitation programme
Time Frame: 10 weeks
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Attendance record
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10 weeks
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Improved knowledge of content in rehabilitation programme
Time Frame: Change from Baseline knowledge of content in rehabilitation programme at 6 months
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Questionaire
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Change from Baseline knowledge of content in rehabilitation programme at 6 months
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Compliance to treatment
Time Frame: 6 months
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Single question about compliance to treatment
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6 months
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Compliance to physical activity
Time Frame: 6 months
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Single question about compliance to physical activity
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6 months
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Visits to hospital, primary care
Time Frame: 6 months
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Single question about number of visits to hospital and primary care
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6 months
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Motivation with rehabilitation programme
Time Frame: 6 months
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Visual analog scale, focus group interview
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6 months
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Stimulation with the of rehabilitation programme
Time Frame: 6 months
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Visual analog scale, focus group interview
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ulrika Einarsson, PhD, Karolinska University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/1276-31/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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