Chronic Lung DiseaseATLAN_TIC01NCT03018717
Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases
A study testing Telemonitoring Constant and Standard clinical care in people with Chronic Lung Disease and Chronic Heart Disease, run by Fundación Pública Andaluza Progreso y Salud at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lung Disease, Chronic Heart Disease
- What is being tested?
- Telemonitoring Constant and Standard clinical care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 5 sitesSpain
- Study dates
- 13 Jun 2016to 13 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Complejo Hospitalario de Jaén
Jaén, 23007
Serranía de Ronda Hospital
Ronda, Málaga, 29400
Universitary Hospital Virgen Macarena
Seville, Seville, 41009
Universitary Hospital Virgen del Rocío
Seville, Seville, 41013
Hospital Universitario de Valme
Seville, 41014
About this study
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
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.
Read the 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.
- Conditions
- Chronic Lung Disease, Chronic Heart Disease
- Being tested
- Telemonitoring Constant, Standard clinical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring ConstantOther
telemedicine of Constant
Standard clinical careOther
The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)
| Study group | Role | What they receive |
|---|---|---|
| Tele-monitoring Constant | Other | 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. Receives: Other: Telemonitoring Constant |
| Standard clinical care | Other | 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 Receives: Other: Standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six month
Secondary outcomes (12)
Number of hospital admissions
Measured: six month
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.
Measured: six month
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.
Measured: At the time of inclusion, at 45 days and after 6 months of follow-up.
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.
Measured: at 45 days and after 6 months of follow-up
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
Measured: at 45 days and after 6 months of follow-up,
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.
Measured: six month
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.
Measured: six month
Number of admissions-visits to Hospital Emergency
Measured: six month
Number of visits to Primary Care Emergencies
Measured: six month
mortality
Measured: six month
Number of days of hospital stay
Measured: six month
Overall cost for patients in euros
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start13 Jun 2016
- Primary completion26 Sep 2018
- Study completion13 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Telefónica S.A., Junta de Andalucia, Salud Responde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018717
- Sponsor's protocol ID
- ATLAN_TIC01
- Acronym
- ATLAN_TIC01
- Status last verified
- Sep 2018
- First submitted
- 12 Dec 2016
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03018717
- Acronym / sponsor ID
- ATLAN_TIC01 / ATLAN_TIC01
- Conditions
- Chronic Lung Disease, Chronic Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Telefónica S.A., Junta de Andalucia, Salud Responde
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 13 Sep 2019 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-monitoring Constant | Other | Other: Telemonitoring ConstantTo 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 | Other | Other: Standard clinical careStandard 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring Constanttelemedicine of Constant | Other | Tele-monitoring Constant |
| Standard clinical careThe patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes) | Other | Standard clinical care |
Primary outcome
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
Time frame: Six month
Monitoring number of hospitalizations and/or number of emergency visits in the period.
12 secondary outcomes
Number of hospital admissions
Time frame: six month
Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial
Time frame: six month
quality of life related to health, of follow-up in both arms of the clinical trial,
Time frame: At the time of inclusion, at 45 days and after 6 months of follow-up.
quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.
Time frame: at 45 days and after 6 months of follow-up
perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.
Time frame: at 45 days and after 6 months of follow-up,
primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method.
Time frame: six month
To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.
Time frame: six month
Number of admissions-visits to Hospital Emergency
Time frame: six month
Number of visits to Primary Care Emergencies
Time frame: six month
mortality
Time frame: six month
Number of days of hospital stay
Time frame: six month
Overall cost for patients in euros
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring Constant and Standard clinical care in people with Chronic Lung Disease and Chronic Heart Disease, run by Fundación Pública Andaluza Progreso y Salud at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.