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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02802618
Other study ID # 2013/1276-31/3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date March 2024

Study information

Verified date March 2024
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Interactive 3D visualization technique
The pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.

Locations

Country Name City State
Sweden Department of physiotherapy, Karolinska University Hospital Stockholm

Sponsors (5)

Lead Sponsor Collaborator
Karolinska University Hospital Flemingsberg Science, Landstingens Ömsesidiga Försäkringsbolag (Löf), The Mats Kleberg Foundation, The Swedish Heart and Lung Association

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved health related quality of life COPD Assessment Test Change from Baseline health related quality of life at 10 weeks
Secondary Improved health related quality of life S:t GeorgeĀ“s Respiratory Questionnaire Change from Baseline health related quality of life at 10 weeks
Secondary Improved health related quality of life Leicester Cough Questionnaire Change from Baseline health related quality of life at 2 and 10 weeks
Secondary Improved exercise self efficacy SCI Exercise Self Efficacy Scale (SCI=Spinal Cord Injury) Change from Baseline exercise self efficacy at 10 weeks
Secondary Improved physical performance JAMAR Hydraulic Hand Dynamometer Change from Baseline physical performance at 10 weeks
Secondary Improved physical performance 6 minute walk test Change from Baseline physical performance at 10 weeks
Secondary Attendance to rehabilitation programme Attendance record 10 weeks
Secondary Improved knowledge of content in rehabilitation programme Questionaire Change from Baseline knowledge of content in rehabilitation programme at 6 months
Secondary Compliance to treatment Single question about compliance to treatment 6 months
Secondary Compliance to physical activity Single question about compliance to physical activity 6 months
Secondary Visits to hospital, primary care Single question about number of visits to hospital and primary care 6 months
Secondary Motivation with rehabilitation programme Visual analog scale, focus group interview 6 months
Secondary Stimulation with the of rehabilitation programme Visual analog scale, focus group interview 6 months
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