Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic obstructive pulmonary disease (COPD), Asthma
Brief summary
The purpose of this study is to determine whether disease management program is effective in preventing acute exacerbations in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma.
Detailed description
The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel. The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease. Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.
Interventions
OTHERPulmonary disease management
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
OTHERUsual care
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
Sponsors
Maccabi Healthcare Services, Israel
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women 2. 40 years or older 3. Having unstable COPD or Asthma
Exclusion criteria
1. Significant LV dysfunction 2. Other severe chronic morbidity compromising short-term survival 3. Significant cognitive impairment or psychiatric disease 4. Bedridden 5. Homeless or no telephone connection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare services utilization for acute exacerbations of pulmonary disease | Every 6 months during 1-3 years' follow-up | The proportion of patients who, due to exacerbation of their COPD or asthma, have at least one out of hours visit to a off-hour non-hospital based acute-care facilities, or a visit to a hospital emergency room, or a hospitalization within the two years of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Every 6 months during 1-3 years' follow-up | Health-related quality of life |
| Pulmonary function tests | Every 6 months during 1-3 years' follow-up | Pulmonary function tests |
| Physical function | Every 6 months during 1-3 years' follow-up | 6-minutes walk test assessment |
| Depression | Every 6 months during 1-3 years' follow-up | PHQ-9 Questionnaire |
Countries
Israel
Outcome results
None listed