Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Comprehensive care
Brief summary
Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.
Detailed description
Design: A randomised controlled trial of patients discharged from hospital after an episode of acute exacerbation of COPD. Patients will be randomised to the intervention arm or usual care group. Setting: Tertiary University affiliated Hospital. Interventions: The Intervention group will receive a comprehensive programme which involves inputs from doctors, respiratory nurses and physiotherapists, providing an individualized care plan for each subject. The components in the programme will include optimization of medications, specialist physician follow up, nursing support in education, and physiotherapist support for pulmonary rehabilitation. Patients in the intervention group will also receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and answer their queries. Patients will also be followed up in the respiratory clinic by respiratory specialist once every 3 months for 1 year. The control group will be managed as the usual care. The discharging physician will determine the patients' medication and follow up as in normal practice. All patients will be asked to return for assessments (spirometry, 6 minute walk test, questionnaires on the severity of dyspnoea and quality of life) at baseline and 12 months Main outcome measures: The primary endpoint is the hospital readmission rate and the secondary endpoints are the quality of life, mortality, lung function and exercise capacity of the patients.
Interventions
OTHERComprehensive 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study. * Patients with age over 40 years
Exclusion criteria
* Patients with asthma * Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 12 months | Measured 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. |
| Mortality | 12 months | From contacting the patient/their family and hospital record retrieval. |
| Lung Function | 12 months | 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. |
| Exercise Capacity | 12 month | Exercise 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. |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| Control Group Control arm with usual care | 90 |
| Total | 180 |
Baseline characteristics
| Characteristic | Comprehensive Care | Control Group | Total |
|---|---|---|---|
| Age, Customized Age (years) | 74.9 years STANDARD_DEVIATION 7.9 | 74.6 years STANDARD_DEVIATION 8.6 | 74.7 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 90 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Hong Kong | 90 participants | 90 participants | 180 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 85 Participants | 87 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
Hospital Readmission
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Care | Hospital Readmission | 1.12 hospital readmissions | Standard Deviation 1.69 |
| Control Group | Hospital Readmission | 1.7 hospital readmissions | Standard Deviation 1.65 |
Secondary
Exercise Capacity
Exercise 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.
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Care | Exercise Capacity | -10.0 meters | Standard Deviation 61.2 |
| Control Group | Exercise Capacity | -22.5 meters | Standard Deviation 71.4 |
Secondary
Lung Function
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.
Time frame: 12 months
Population: Percentage of predicted FEV1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Care | Lung Function | 0.8 Percentage of Predicted FEV1 | Standard Deviation 6.8 |
| Control Group | Lung Function | -0.5 Percentage of Predicted FEV1 | Standard Deviation 8.5 |
Secondary
Mortality
From contacting the patient/their family and hospital record retrieval.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comprehensive Care | Mortality | 10 participants |
| Control Group | Mortality | 12 participants |
Secondary
Quality of Life
Measured 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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Care | Quality of Life | -6.9 units on a scale | Standard Deviation 15.3 |
| Control Group | Quality of Life | -0.1 units on a scale | Standard Deviation 15.7 |