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To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD), with telemonitoring and telephone control, is equally effective and more efficient in terms of use of health care resources, that a home care provided by hospital respiratory nurses and pulmonologists.
This study seeks to improve the health of patients with AECOPD by home care after discharge from the Hospital using the technology of the information and the communication. The investigators want evaluate the efficiency, satisfaction (patients, keepers) and effectiveness of a program of early discharge with home care in patients with AECOPD with telemonitoring and telephone control, in relation to the traditional protocol of home care based on nurse and pulmonologist visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telemonitoring and telephone control | Active Comparator | Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. |
|
| home care | No Intervention | Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring and telephone control | Procedure | Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Until the First Exacerbation | Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease. | Change from stable to exacerbation the first time at 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| SATISFAD 10 | Instrument that evaluates satisfaction with home care services in a self-administered. The score ranges from 0 to 30, with the worst value being zero and the best value being 30. | Participants will be followed for the duration home care, an expected average of 7 days |
| State-Trait Anxiety Inventory (STAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antolín Lopez Viña, physician | Hospital Puerta de Hierro | Study Director |
| Antolín Lopez Viña, MD | Hospital Puerta de Hierro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary Hospital Puerta de Hierro. | Majadahonda | Madrid | 28222 | Spain |
Share All of the individual participant data collected during the trial, after identification.
Immediately following publication. No end date.
Proposals should be directed to drapat1@yahoo.es. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemonitoring and Telephone Control | Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist. |
| FG001 | Home Care | Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemonitoring and Telephone Control | Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Until the First Exacerbation | Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease. | The overall number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module, because in the telemedicine group and the home care group, patients who readmission were not included, nor was the patient in whom the monitor did not work. | Posted | Median | Inter-Quartile Range | days | Change from stable to exacerbation the first time at 6 month |
|
During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telemonitoring and Telephone Control | Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra Patricia Mínguez Clemente | Hospital Puerta de Hierro | 911916859 | drapat3@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2012 | Aug 1, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2012 | Aug 1, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
The structure of the scale resulting from the combination of item polarity dimensions and the original two factors (State and Trait Anxiety). Minimum value 0, maximum value 120. Lower score indicates higher anxiety. |
| Participants will be followed for the duration of home care, an expected average of 7 days |
| Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | Consists of a series of 4 contrasting questions with answers dichotomous yes / no, reflecting the patient's behavior regarding compliance with medication. They are intended to assess whether the patient adopts correct attitudes regarding treatment for his illness; it is assumed that if attitudes they are incorrect the patient is non-compliant. | Participants will be followed for the duration of home care up 24 weeks |
| Monitoring Compliance | It represents the compliance of the patients with respect to the sending of constants through the telemedicine monitor that should be (following the protocol) at least twice a day. The patient was considered compliant if he sent the constant at least 2 twice a day or non-compliant otherwise. | Participants will be followed for the duration of home care, an expected average of 7 days |
| Number of Home Visits | Participants will be followed for the duration of home care, an expected average of 7 days |
| COPD Assessment Test (CAT) | It's a simple questionnaire for assessing and monitoring COPD. It quantifies chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment. It's self-administered in 2 min. It consists of 8 items that measure aspects of cough, expectoration, chest tightness, dyspnea, domestic activities, self-confidence, sleep and energy. Each section is scored from 0 to 5 and therefore a maximum of 40 points can be obtained; a higher score indicates a greater negative impact of COPD. Significant clinical changes correspond to a variation of 2 points or more. | Participants will be followed for the duration of home care and up to 4 weeks |
| Protocol Violation |
|
| BG001 | Home Care | Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index (BMI) (Mean (Standard Deviation) | Mean | Standard Deviation | Kg/m^2 |
|
| OG001 | Home Care | Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits). |
|
|
|
| Secondary | SATISFAD 10 | Instrument that evaluates satisfaction with home care services in a self-administered. The score ranges from 0 to 30, with the worst value being zero and the best value being 30. | Posted | Median | Inter-Quartile Range | score on a scale | Participants will be followed for the duration home care, an expected average of 7 days |
|
|
|
| Secondary | State-Trait Anxiety Inventory (STAI) | The structure of the scale resulting from the combination of item polarity dimensions and the original two factors (State and Trait Anxiety). Minimum value 0, maximum value 120. Lower score indicates higher anxiety. | Not all study participants completed the test, so it does not correspond to the number of the flow chart. | Posted | Median | Inter-Quartile Range | score on a scale | Participants will be followed for the duration of home care, an expected average of 7 days |
|
|
|
| Secondary | Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | Consists of a series of 4 contrasting questions with answers dichotomous yes / no, reflecting the patient's behavior regarding compliance with medication. They are intended to assess whether the patient adopts correct attitudes regarding treatment for his illness; it is assumed that if attitudes they are incorrect the patient is non-compliant. | Not all study participants completed the test, so it does not correspond to the number of the flow chart. | Posted | Number | percentage of adherents | Participants will be followed for the duration of home care up 24 weeks |
|
|
|
| Secondary | Monitoring Compliance | It represents the compliance of the patients with respect to the sending of constants through the telemedicine monitor that should be (following the protocol) at least twice a day. The patient was considered compliant if he sent the constant at least 2 twice a day or non-compliant otherwise. | In the home care group, patients did not send constants. Data from 55 patients were analyzed (2 readmissions and one patient in which the monitor failed were not included in the analysis) | Posted | Mean | Standard Deviation | sending of constant | Participants will be followed for the duration of home care, an expected average of 7 days |
|
|
|
| Secondary | Number of Home Visits | Posted | Mean | Standard Deviation | visits | Participants will be followed for the duration of home care, an expected average of 7 days |
|
|
|
| Secondary | COPD Assessment Test (CAT) | It's a simple questionnaire for assessing and monitoring COPD. It quantifies chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment. It's self-administered in 2 min. It consists of 8 items that measure aspects of cough, expectoration, chest tightness, dyspnea, domestic activities, self-confidence, sleep and energy. Each section is scored from 0 to 5 and therefore a maximum of 40 points can be obtained; a higher score indicates a greater negative impact of COPD. Significant clinical changes correspond to a variation of 2 points or more. | Not all study participants completed the test, so it does not correspond to the number of the flow chart. | Posted | Median | Inter-Quartile Range | score on a scale | Participants will be followed for the duration of home care and up to 4 weeks |
|
|
|
| 1 |
| 58 |
| 2 |
| 58 |
| 0 |
| 58 |
| EG001 | Home Care | Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits). | 0 | 58 | 2 | 58 | 0 | 58 |
| rapid atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| necrotizing pneumonia. | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pain secondary to vertebral crushing | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |