Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Distance in meters covered over a time of 6 minutes 0 |
Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
Baseline |
|
Primary |
Distance in meters covered over a time of 6 minutes 1 |
Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
8 weeks |
|
Primary |
Distance in meters covered over a time of 6 minutes 2 |
Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
7 months |
|
Primary |
Distance in meters covered over a time of 6 minutes 3 |
Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
12 months |
|
Secondary |
Dyspnoea 0 |
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea |
Baseline |
|
Secondary |
Dyspnoea 1 |
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea |
8 weeks |
|
Secondary |
Dyspnoea 2 |
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea |
7 months |
|
Secondary |
Dyspnoea 3 |
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea |
12 months |
|
Secondary |
Health-Related Quality of Life 0 |
European quality of life-5 dimensions (EQ5D) |
Baseline |
|
Secondary |
Health-Related Quality of Life 1 |
European quality of life-5 dimensions (EQ5D) |
8 weeks |
|
Secondary |
Health-Related Quality of Life 2 |
European quality of life-5 dimensions (EQ5D) |
7 months |
|
Secondary |
Health-Related Quality of Life 3 |
European quality of life-5 dimensions (EQ5D) |
12 months |
|
Secondary |
Number of emergency department visits due to COPD exacerbation 0 |
Number of exacerbations (accessing to emergency department) |
Baseline |
|
Secondary |
Number of emergency department visits due to COPD exacerbation 1 |
Number of exacerbations (accessing to emergency department) |
8 weeks |
|
Secondary |
Number of emergency department visits due to COPD exacerbation 2 |
Number of exacerbations (accessing to emergency department) |
7 months |
|
Secondary |
Number of emergency department visits due to COPD exacerbation 3 |
Number of exacerbations (accessing to emergency department) |
12 months |
|
Secondary |
COPD symptom control 0 |
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control |
Baseline |
|
Secondary |
COPD symptom control 1 |
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control |
8 weeks |
|
Secondary |
COPD symptom control 2 |
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control |
7 months |
|
Secondary |
COPD symptom control 3 |
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control |
12 months |
|
Secondary |
Anxiety and Depression 0 |
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring |
Baseline |
|
Secondary |
Anxiety and Depression 1 |
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring |
8 weeks |
|
Secondary |
Anxiety and Depression 2 |
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring |
7 months |
|
Secondary |
Anxiety and Depression 3 |
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring |
12 months |
|
Secondary |
Physical activity 0 |
Counting steps per day with the pedometer Yamax EX510 |
Baseline |
|
Secondary |
Physical activity 1 |
Counting steps per day with the pedometer Yamax EX510 |
8 weeks |
|
Secondary |
Physical activity 2 |
Counting steps per day with the pedometer Yamax EX510 |
7 months |
|
Secondary |
Physical activity 3 |
Counting steps per day with the pedometer Yamax EX510 |
12 months |
|
Secondary |
Functional capacity 0 |
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
Baseline |
|
Secondary |
Functional capacity 1 |
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
8 weeks |
|
Secondary |
Functional capacity 2 |
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
7 months |
|
Secondary |
Functional capacity 3 |
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
12 months |
|