Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
Brief Summary: Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times \< 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.


Options:
A: Inclusion Criteria:

* CHF/COPD patients
* English-speaking
* Medicare beneficiaries

Amendment to Inclusion Criteria:

* Recruited non-Medicare eligible beneficiaries

Exclusion Criteria:

* Prognosis of 6 months or less
* Cognitive impairment with no available proxy/caregiver
* No possession of a phone

Amendments to exclusion criteria:

* heart or lung transplant recipients
* dialysis patients
* individuals already in the Cystic Fibrosis program or receiving intensive monitored care
* individuals with a ventricular assist device (LVAD; RVAD; BiVAD)
* individuals utilizing a pre-paid phone service
B: Inclusion Criteria:

* COPD defined as chronic irreversible airflow limitation with FEV1 \< lower limit of normal for age as % predicted and a FEV1/FVC ratio \< than lower limit of normal (usually 70%) \[5\]

Plus ≥ 2 comorbidities commonly associated with COPD as identified in the Canadian Thoracic Society COPD guidelines\*

1. Cardiovascular disease
2. Osteopenia and osteoporosis
3. Glaucoma and cataracts
4. Cachexia and malnutrition
5. Peripheral muscle dysfunction
6. Lung cancer
7. Metabolic syndrome (diabetes mellitus)
8. Depression
9. Chronic kidney disease OR Other conditions as primary admitting/presenting diagnosis + COPD as significant comorbidity + ≥ 1 other comorbidity

THAT

1. Get admitted to participating hospital; or
2. Present to participating hospital ED; or
3. Have first referral to Respiratory Centre/Respirology team

AND HAVE

1. ≥ 1 ED presentation/hospital admission in previous 12 months
2. ≥ 50 years age

Exclusion Criteria:

1. No access to primary care physician
2. Primary diagnosis of asthma
3. Terminal diagnosis (metastatic disease with a life expectancy of ≤ 6 months)
4. Dementia and absence of family caregiver able to assist with activation of the action plan and feedback on ongoing status and care coordination
5. Uncontrolled psychiatric illness
6. Inability to understand, read, and write English
7. No access to a phone
8. Inability to attend follow up at one of the participating sites
C: Inclusion Criteria:

* mild to very severe COPD.
* age ≥ 45 years of age with no other major healthproblems.
* clinically stable at the time of enrollment into the study.
* insomnia.

Exclusion criteria:

* evidence of restrictive lung disease or asthma.
* pulse oximetry reading of \< 90% at rest or \< 85% at night for \> 5 min.
* evidence of a major sleep disorder other than insomnia.
* hypnotic use.
* acute respiratory infection within the previous 2 months.
* presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
* a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of \> 11.
* currently participating in pulmonary rehabilitation.
D: Inclusion Criteria:

* 50 years and over
* 'At Risk' by having one or more of the following: a. Visits to emergency dept within the past 6 months; b. Admission to hospital for a medical problem in past 6 months; c. High service use profiles; d. Polypharmacy; e. Other high risk factors
* Capable of giving informed consent
* Able to use the Care Companion technology

Exclusion Criteria:

* Cognitive impairment such that they cannot give informed consent
* Unable or unwilling to use the telehomecare equipment
* Unlikely to tolerate the intensive intervention
* Language or cultural barriers
* Being acutely ill or having an unstable condition on entry to the study

Answer: C