Back to resultsIntegral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases (ATLAN_TIC01)
Primary Purpose
Chronic Lung Disease, Chronic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemonitoring Constant
Standard clinical care
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Lung Disease
Eligibility Criteria
Inclusion Criteria:
- Majority legal age (18 years of age or older)
- Present any of the following shortcomings:
Heart failure with baseline dyspnea ≥III of New York Heart Association (NYHA) Chronic respiratory insufficiency with basal dyspnea ≥III of Medical Research Council (MRC) Scale and / or oxygen saturation <90% and / or home oxygen therapy.
- Present Heart Failure or Respiratory Insufficiency with basal dyspnea grade <III (according to NYHA and MRC respectively) but have presented 2 or more income in the last year.
- Score of Patients with terminal or palliative medical diseases (score PALIAR) index between 0 and 7 points.
- To present one of the following assistance situations: hospital admission, follow-up in Home Hospitalization or Palliative Care Teams, specialized outpatient follow-up.
- Speak, understand, read and write Spanish, either the patient or the primary caregiver.
- Have basic knowledge of the use of mobile phones and applications of computer tablets (such knowledge will be confirmed by personal interview, with test of the device).
- Informed consent to participate in the study
Exclusion Criteria:
- Presence of malignant neoplastic disease ACTIVE except localized adenocarcinoma of prostate in hormonal treatment, and / or cutaneous basocellular-squamous cell carcinoma.
- In the case of Chronic Renal Disease if there is the possibility of entry into Substitutive Therapies (hemodialysis or transplantation)
- In the case of chronic liver disease, if there is a possibility of liver transplantation.
- Chronic neurological disease with established cognitive impairment (E. Pfeiffer with 7 or more errors and / or Mild cognitive evaluated (ECM with ≤18 points).
- Clinical situation of agony.
- Surprise question ("Would you be surprised if your patient died in the next 6 months?") With the result "I would not be surprised" + PALIAR Score Score ≥7.5 points.
- Participate in another tele-health initiative.
- Go simultaneously to a private health service and / or be institutionalized
Sites / Locations
- Serranía de Ronda Hospital
- Universitary Hospital Virgen Macarena
- Universitary Hospital Virgen del Rocío
- Complejo Hospitalario de Jaén
- Hospital Universitario de Valme
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Tele-monitoring Constant
Standard clinical care
Arm Description
To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan. Patients will receive in their home a kit consisting of a briefcase containing all equipment (scale, pulse-oximeter ... etc) and a logo access to devices (Tablet) through mobile communications m2m between patient and platform Management for Chronic Patients.
Standard clinical care plan shared between plan of attention to the patient with Pluri-pathological process and the care plan for patients with chronic diseases, based on a comprehensive clinical assistance shared between Primary Care and Hospital Care
Outcomes
Primary Outcome Measures
Reduce the number of hospital admissions and / or the number of hospital emergency visits and / or the number of primary care visits of the patients in the TELEPAC arm (patients with tele-monitoring) with respect to the PAC arm (patient without tele-Moni
Monitoring number of hospitalizations and/or number of emergency visits in the period.
Secondary Outcome Measures
Number of hospital admissions
Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial
analyze the safety of the two arms by monitoring the number of adverse events and adverse clinical events related to the two arms of the clinical trial.
quality of life related to health, of follow-up in both arms of the clinical trial,
Using a standardized Using a standardized questionnaire of quality of live related to health in adults (EQ-5D) adapted to Spanish.
quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.
Using the standardized questionnaire Service Performance (SERVPERF) adapted to health.
perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.
Using the Perceived quality for technical support (TSUQ) standardized questionnaire adapted
primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method.
using each of the patients that did not require hospital admission and / or emergency visits, as a unit of cost Of each patient.
To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.
using each of the secondary efficacy variables as unit of cost and each patient's overall cost unit.
Number of admissions-visits to Hospital Emergency
Number of visits to Primary Care Emergencies
mortality
Number of days of hospital stay
Overall cost for patients in euros
Full Information
NCT ID
NCT03018717
First Posted
December 12, 2016
Last Updated
June 18, 2019
Sponsor
Fundación Pública Andaluza Progreso y Salud
Collaborators
Telefónica S.A., Agency of Social Services and Dependency of Andalusia, Salud Responde
1. Study Identification
Unique Protocol Identification Number
NCT03018717
Brief Title
Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases
Acronym
ATLAN_TIC01
Official Title
Randomized Multicenter Clinical Trial of a Integral Clinical Care Plan Shared With or Without Telemonitoring of Bio Constants in Patients With Chronic Diseases in Advanced Stages. ATLANTIC Project
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 13, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud
Collaborators
Telefónica S.A., Agency of Social Services and Dependency of Andalusia, Salud Responde
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Information and communications technologies (ICT) currently constitute a key element in the innovation and improvement of providing health-care to frail populations with advanced chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven conclusively. The investigators are going to carry out a multi-center, randomized, parallel groups, phase III clinical trial in adult patient with heart and/or lung advanced diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of bio-parameters added to optimal standard of clinical care (shared clinical care plan) compared to the shared clinical care plan exclusively.
Detailed Description
a total number of 510 patients will be divided in 3 centers: Hospital University Virgen del Rocío; Hospital University Virgen Macarena and Public Hospital Comarcal of Serranía de Ronda. Patient will be randomized in Tele-monitoring Constant (TELEPAC) To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan or in Standard Clinical Care (PAC) based on a comprehensive clinical assistance shared between Primary Care and Hospital Care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lung Disease, Chronic Heart Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-monitoring Constant
Arm Type
Other
Arm Description
To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan. Patients will receive in their home a kit consisting of a briefcase containing all equipment (scale, pulse-oximeter ... etc) and a logo access to devices (Tablet) through mobile communications m2m between patient and platform Management for Chronic Patients.
Arm Title
Standard clinical care
Arm Type
Other
Arm Description
Standard clinical care plan shared between plan of attention to the patient with Pluri-pathological process and the care plan for patients with chronic diseases, based on a comprehensive clinical assistance shared between Primary Care and Hospital Care
Intervention Type
Other
Intervention Name(s)
Telemonitoring Constant
Intervention Description
telemedicine of Constant
Intervention Type
Other
Intervention Name(s)
Standard clinical care
Intervention Description
The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)
Primary Outcome Measure Information:
Title
Reduce the number of hospital admissions and / or the number of hospital emergency visits and / or the number of primary care visits of the patients in the TELEPAC arm (patients with tele-monitoring) with respect to the PAC arm (patient without tele-Moni
Description
Monitoring number of hospitalizations and/or number of emergency visits in the period.
Time Frame
Six month
Secondary Outcome Measure Information:
Title
Number of hospital admissions
Time Frame
six month
Title
Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial
Description
analyze the safety of the two arms by monitoring the number of adverse events and adverse clinical events related to the two arms of the clinical trial.
Time Frame
six month
Title
quality of life related to health, of follow-up in both arms of the clinical trial,
Description
Using a standardized Using a standardized questionnaire of quality of live related to health in adults (EQ-5D) adapted to Spanish.
Time Frame
At the time of inclusion, at 45 days and after 6 months of follow-up.
Title
quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.
Description
Using the standardized questionnaire Service Performance (SERVPERF) adapted to health.
Time Frame
at 45 days and after 6 months of follow-up
Title
perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.
Description
Using the Perceived quality for technical support (TSUQ) standardized questionnaire adapted
Time Frame
at 45 days and after 6 months of follow-up,
Title
primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method.
Description
using each of the patients that did not require hospital admission and / or emergency visits, as a unit of cost Of each patient.
Time Frame
six month
Title
To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.
Description
using each of the secondary efficacy variables as unit of cost and each patient's overall cost unit.
Time Frame
six month
Title
Number of admissions-visits to Hospital Emergency
Time Frame
six month
Title
Number of visits to Primary Care Emergencies
Time Frame
six month
Title
mortality
Time Frame
six month
Title
Number of days of hospital stay
Time Frame
six month
Title
Overall cost for patients in euros
Time Frame
six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Majority legal age (18 years of age or older)
Present any of the following shortcomings:
Heart failure with baseline dyspnea ≥III of New York Heart Association (NYHA) Chronic respiratory insufficiency with basal dyspnea ≥III of Medical Research Council (MRC) Scale and / or oxygen saturation <90% and / or home oxygen therapy.
Present Heart Failure or Respiratory Insufficiency with basal dyspnea grade <III (according to NYHA and MRC respectively) but have presented 2 or more income in the last year.
Score of Patients with terminal or palliative medical diseases (score PALIAR) index between 0 and 7 points.
To present one of the following assistance situations: hospital admission, follow-up in Home Hospitalization or Palliative Care Teams, specialized outpatient follow-up.
Speak, understand, read and write Spanish, either the patient or the primary caregiver.
Have basic knowledge of the use of mobile phones and applications of computer tablets (such knowledge will be confirmed by personal interview, with test of the device).
Informed consent to participate in the study
Exclusion Criteria:
Presence of malignant neoplastic disease ACTIVE except localized adenocarcinoma of prostate in hormonal treatment, and / or cutaneous basocellular-squamous cell carcinoma.
In the case of Chronic Renal Disease if there is the possibility of entry into Substitutive Therapies (hemodialysis or transplantation)
In the case of chronic liver disease, if there is a possibility of liver transplantation.
Chronic neurological disease with established cognitive impairment (E. Pfeiffer with 7 or more errors and / or Mild cognitive evaluated (ECM with ≤18 points).
Clinical situation of agony.
Surprise question ("Would you be surprised if your patient died in the next 6 months?") With the result "I would not be surprised" + PALIAR Score Score ≥7.5 points.
Participate in another tele-health initiative.
Go simultaneously to a private health service and / or be institutionalized
Facility Information:
Facility Name
Serranía de Ronda Hospital
City
Ronda
State/Province
Málaga
ZIP/Postal Code
29400
Country
Spain
Facility Name
Universitary Hospital Virgen Macarena
City
Sevilla
State/Province
Seville
ZIP/Postal Code
41009
Country
Spain
Facility Name
Universitary Hospital Virgen del Rocío
City
Sevilla
State/Province
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Complejo Hospitalario de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Universitario de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases
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