Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community (COPD_CDM)

Sheba Medical Center

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Disease management; Other: Best care

Study type: Interventional

Funder types: Other

Identifiers

NCT00982384

SHEBA-09-7120-OK-CTIL

Details and patient eligibility

About

The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).

Full description

The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.

The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.

Enrollment: 1,202 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 40 years or older
2. Advanced COPD

Exclusion criteria

1. Permanent tracheostomy
2. Heart failure with significant left-ventricular dysfunction
3. Severe other chronic disease
4. Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
5. No telephone or permanent address
6. Bedridden
7. Refusal to use telemonitoring equipment
8. Participation in another clinical trial

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,202 participants in 2 patient groups

Disease management

Experimental group

Description:

Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients

Treatment:

Other: Disease management

Best care

Active Comparator group

Description:

Best care according to clinical guidelines for COPD patients

Treatment:

Other: Best care