COPD Exacerbation
Conditions
Keywords
Telemonitoring, COPD, Home care
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETelemonitoring 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.
Sponsors
Dr. López Viña
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients admitted to the hospital with COPD exacerbation * No concomitant serious unstable diseases * Without fever in 48 hours * Aerosol treatment at the most every 6 hours * Treatment with glucocorticoid intravenous \< 40 mg twice a day * A thoracic radiograph without new disease * Subjective improvement of the patient * Familiar suitable environment
Exclusion criteria
* Neoplasias and other chronic diseases in terminal situation * Alcoholism * Intravenous medication * Disability to understand and take part in the program * Admitted to intensive care unit (ICU) or non invasive mechanical ventilation during the exacerbation * Unstability hemodynamic * To be an institutionalized patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until the First Exacerbation | Change from stable to exacerbation the first time at 6 month | Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) | Participants will be followed for the duration of home care, an expected average of 7 days | 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. |
| Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | Participants will be followed for the duration of home care up 24 weeks | 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. |
| SATISFAD 10 | Participants will be followed for the duration home care, an expected average of 7 days | 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. |
| Number of Home Visits | Participants will be followed for the duration of home care, an expected average of 7 days | — |
| COPD Assessment Test (CAT) | Participants will be followed for the duration of home care and up to 4 weeks | 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. |
| Monitoring Compliance | Participants will be followed for the duration of home care, an expected average of 7 days | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| Home Care Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits). | 58 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Protocol Violation | 4 | 3 |
Baseline characteristics
| Characteristic | Telemonitoring and Telephone Control | Home Care | Total |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 8 | 70 years STANDARD_DEVIATION 8 | 69 years STANDARD_DEVIATION 8 |
| Body mass index (BMI) (Mean (Standard Deviation) | 27.1 Kg/m^2 STANDARD_DEVIATION 4 | 26.5 Kg/m^2 STANDARD_DEVIATION 4 | 26.8 Kg/m^2 STANDARD_DEVIATION 4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 23 Participants | 36 Participants |
| Sex: Female, Male Male | 45 Participants | 35 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 58 | 0 / 58 |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 2 / 58 | 2 / 58 |
Outcome results
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.
Time frame: Change from stable to exacerbation the first time at 6 month
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telemonitoring and Telephone Control | Time Until the First Exacerbation | 47 days |
| Home Care | Time Until the First Exacerbation | 48 days |
p-value: <0.05Log Rank
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.
Time frame: Participants will be followed for the duration of home care and up to 4 weeks
Population: Not all study participants completed the test, so it does not correspond to the number of the flow chart.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Telemonitoring and Telephone Control | COPD Assessment Test (CAT) | Initial | 10 score on a scale |
| Telemonitoring and Telephone Control | COPD Assessment Test (CAT) | At first month | 8 score on a scale |
| Home Care | COPD Assessment Test (CAT) | Initial | 15 score on a scale |
| Home Care | COPD Assessment Test (CAT) | At first month | 8 score on a scale |
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.
Time frame: Participants will be followed for the duration of home care, an expected average of 7 days
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemonitoring and Telephone Control | Monitoring Compliance | 2.23 sending of constant | Standard Deviation 1 |
Secondary
Number of Home Visits
Time frame: Participants will be followed for the duration of home care, an expected average of 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemonitoring and Telephone Control | Number of Home Visits | 3.8 visits | Standard Deviation 1 |
| Home Care | Number of Home Visits | 5.1 visits | Standard Deviation 2 |
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.
Time frame: Participants will be followed for the duration of home care up 24 weeks
Population: Not all study participants completed the test, so it does not correspond to the number of the flow chart.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telemonitoring and Telephone Control | Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | Initial | 77 percentage of adherents |
| Telemonitoring and Telephone Control | Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | At 6 month | 86 percentage of adherents |
| Home Care | Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | Initial | 78 percentage of adherents |
| Home Care | Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test | At 6 month | 87 percentage of adherents |
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.
Time frame: Participants will be followed for the duration home care, an expected average of 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telemonitoring and Telephone Control | SATISFAD 10 | 30 score on a scale |
| Home Care | SATISFAD 10 | 30 score on a scale |
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.
Time frame: Participants will be followed for the duration of home care, an expected average of 7 days
Population: Not all study participants completed the test, so it does not correspond to the number of the flow chart.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Telemonitoring and Telephone Control | State-Trait Anxiety Inventory (STAI) | State | 15 score on a scale |
| Telemonitoring and Telephone Control | State-Trait Anxiety Inventory (STAI) | Trait | 20 score on a scale |
| Home Care | State-Trait Anxiety Inventory (STAI) | State | 17 score on a scale |
| Home Care | State-Trait Anxiety Inventory (STAI) | Trait | 23 score on a scale |