Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Brief Summary: The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.


Options:
A: Inclusion Criteria:

* Adults greater than 18 years of age and less than 64 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following:

  * patients with spirometrically confirmed COPD at high risk for repeat hospitalization or emergency department (ED) visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation,
  * chronic home use of oxygen, or
  * a course of systemic corticosteroid therapy in the preceding 12 months.

Exclusion Criteria:

* patients not expected to survive their hospitalization,
* presence of metastatic cancer,
* bed-bound individuals,
* non-English speaking patients, and
* patients unable to provide informed consent.
B: Inclusion Criteria:

Population to be studied

The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.

Inclusion Criteria:

1. Diagnosis of COPD confirmed by all of the following:

   1. FEV1/FVC \< 0.70
   2. FEV1 \< 80%
   3. Age \> 40 years
   4. A current or past history of cigarette smoking (\> 10 pack-years)
2. COPD hospitalization in the previous year
3. Receives care at participating VA medical center

   1. Enrolled in either primary care or pulmonary clinic at the VA
   2. Seen at least once in the past year in either primary care or pulmonary clinic
4. No COPD exacerbations in last 4 weeks
5. English-speaking
6. Access to telephone

Exclusion Criteria:

1. Primary clinical diagnosis of asthma
2. Medical conditions affecting the ability to participate in the study such as:

   1. Comorbid illness likely to limit life expectancy \< 1 year
   2. Decompensated heart failure
   3. Dementia
   4. Uncontrolled psychiatric illness
3. Participation in another clinical intervention trial in the previous 30 days
C: Inclusion Criteria:

1. Age:75 y or older
2. Co-morbidity or dependency. At least one of the following criteria: Charlson index \>3, dependency in 2 or more basic activities of daily living,treatment with 5 or more drugs, urgent hospitalization in the last 3 months, three or more diseases with active treatment, limitation in daily living because of vision or hearing impairment, cognition deficit, Parkinson disease, diabetes mellitus, chronic obstructive lung disease, severe anemia, constitutional syndrome
3. Hospital admission with a main diagnosis of heart failure (according to the criteria of the European Society of Cardiology or Framingham criteria) in NYHA functional class II-IV.

Exclusion Criteria:

1. Participation refusal
2. Terminal illness
3. Cognitive decline or severe cognitive deficit, which does not permit a minimum knowledge of the disease, or lack of carers which give consent to study participation
4. Clinical instability as assessed with the Kosecof index
5. Being in waiting list for organ transplant or cardiac surgery
6. Inability to be followed-up because of other reasons (change of place of residence,..)
7. Institutionalization
D: Inclusion Criteria:

* Male or female, aged more than 35 years
* Physician labelled diagnosis of COPD, emphysema or chronic bronchitis
* Ex or current smoker of more than 20 pack years
* FEV1 less than 80% of predicted
* Patients may be taking long or short acting bronchodilators and/or inhaled or oral corticosteroids and/or theophyllines.
* Patients having attended at least 60% of the exercise sessions in the initial PR(22)\* \* This is an inclusion criterion for randomisation to receive maintenance PR or standard medical care but not entry into the study

Exclusion Criteria:

* Significant cardiac or pulmonary disease other than COPD such that COPD is the minor contribution to the patients' symptoms.
* Myocardial infarction within the previous 6 months or unstable angina
* Respiratory infection defined as cough, antibiotic use or purulent sputum within 4 weeks prior to randomisation.
* Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of the study.
* Abnormalities in cognitive functioning that would limit the patient's ability to undertake the procedures required in the study.
* Unable to give written informed consent.

Answer: C