Trial Outcomes & Findings for A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease (NCT NCT01108835)
NCT ID: NCT01108835
Last Updated: 2017-08-23
Results Overview
To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
12 months
Results posted on
2017-08-23
Participant Flow
Participant milestones
| Measure |
Comprehensive Care
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
Control arm with usual care
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
73
|
69
|
|
Overall Study
NOT COMPLETED
|
17
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Comprehensive Care
n=90 Participants
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
n=90 Participants
Control arm with usual care
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years)
|
74.9 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
74.6 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
74.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
90 participants
n=5 Participants
|
90 participants
n=7 Participants
|
180 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTo investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.
Outcome measures
| Measure |
Comprehensive Care
n=90 Participants
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
n=90 Participants
Control arm with usual care
|
|---|---|---|
|
Hospital Readmission
|
1.12 hospital readmissions
Standard Deviation 1.69
|
1.7 hospital readmissions
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: 12 monthsMeasured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.
Outcome measures
| Measure |
Comprehensive Care
n=90 Participants
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
n=90 Participants
Control arm with usual care
|
|---|---|---|
|
Quality of Life
|
-6.9 units on a scale
Standard Deviation 15.3
|
-0.1 units on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: 12 monthsFrom contacting the patient/their family and hospital record retrieval.
Outcome measures
| Measure |
Comprehensive Care
n=90 Participants
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
n=90 Participants
Control arm with usual care
|
|---|---|---|
|
Mortality
|
10 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percentage of predicted FEV1
Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.
Outcome measures
| Measure |
Comprehensive Care
n=90 Participants
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
n=90 Participants
Control arm with usual care
|
|---|---|---|
|
Lung Function
|
0.8 Percentage of Predicted FEV1
Standard Deviation 6.8
|
-0.5 Percentage of Predicted FEV1
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 12 monthExercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.
Outcome measures
| Measure |
Comprehensive Care
n=90 Participants
Comprehensive care
Comprehensive care programme: Intervention group:
* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.
|
Control Group
n=90 Participants
Control arm with usual care
|
|---|---|---|
|
Exercise Capacity
|
-10.0 meters
Standard Deviation 61.2
|
-22.5 meters
Standard Deviation 71.4
|
Adverse Events
Comprehensive Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place