Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatment interactive 3d visualization technique
Sponsor Karolinska University Hospital
Collaborator The Swedish Heart and Lung Association
Start date October 2013
End date October 2016
Trial size 40 participants
Trial identifier NCT02802618, 2013/1276-31/3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Experimental)
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.
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.
(No Intervention)
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.

Primary Outcomes

Measure
Improved health related quality of life
time frame: Change from Baseline health related quality of life at 10 weeks

Secondary Outcomes

Measure
Improved health related quality of life
time frame: Change from Baseline health related quality of life at 10 weeks
Improved health related quality of life
time frame: Change from Baseline health related quality of life at 2 and 10 weeks
Improved exercise self efficacy
time frame: Change from Baseline exercise self efficacy at 10 weeks
Improved physical performance
time frame: Change from Baseline physical performance at 10 weeks
Improved physical performance
time frame: Change from Baseline physical performance at 10 weeks
Attendance to rehabilitation programme
time frame: 10 weeks
Improved knowledge of content in rehabilitation programme
time frame: Change from Baseline knowledge of content in rehabilitation programme at 6 months
Compliance to treatment
time frame: 6 months
Compliance to physical activity
time frame: 6 months
Visits to hospital, primary care
time frame: 6 months
Motivation with rehabilitation programme
time frame: 6 months
Stimulation with the of rehabilitation programme
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)
Principal investigator Ulrika Einarsson, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.