Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
Brief Summary: This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.

It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.


Options:
A: 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
B: Inclusion Criteria:

* diagnosed COPD by spirometry
* in treatment corresponding to GOLD-guidelines
* motivated for treatment of COPD
* COPD is the primary disease
* fixed residence and be affiliated to a general practitioner in North Denmark Region
* At least one of the following criteria should also be met: MRCm (modified) ≥ 2 or MRC ≥3, CAT ≥ 10, have had at least 2 exacerbations within the last 12 months

Exclusion Criteria:

* no phone line or GSM coverage
* unable to understand Danish sufficiently to complete study questionnaires
* have a cognitive impairment
C: Inclusion Criteria:

* CRF patients discharged from Respiratory Unit with home MV

Exclusion Criteria:

* Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
* Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
* Being admitted to a nursing home
* Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
* Refusal to give informed consent
D: Inclusion Criteria:

* Diagnosis of COPD

Exclusion Criteria:

* Diagnosis of other significant lung disease (eg. interstitial lung disease) or dementia
* Lack of WiFi at home
* Inability to speak English
* Inability to use this technology due to physical or cognitive impairment

Answer: D