Chronic Lung Disease Clinical Trial
— ATLAN_TIC01Official 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.
Status | Active, not recruiting |
Enrollment | 510 |
Est. completion date | September 13, 2019 |
Est. primary completion date | September 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario de Jaén | Jaén | |
Spain | Serranía de Ronda Hospital | Ronda | Málaga |
Spain | Hospital Universitario de Valme | Sevilla | |
Spain | Universitary Hospital Virgen del Rocío | Sevilla | Seville |
Spain | Universitary Hospital Virgen Macarena | Sevilla | Seville |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza Progreso y Salud | Agency of Social Services and Dependency of Andalusia, Salud Responde, Telefónica S.A. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Six month | |
Secondary | Number of hospital admissions | six month | ||
Secondary | 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. | six month | |
Secondary | 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. | At the time of inclusion, at 45 days and after 6 months of follow-up. | |
Secondary | 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. | at 45 days and after 6 months of follow-up | |
Secondary | 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 | at 45 days and after 6 months of follow-up, | |
Secondary | 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. | six month | |
Secondary | 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. | six month | |
Secondary | Number of admissions-visits to Hospital Emergency | six month | ||
Secondary | Number of visits to Primary Care Emergencies | six month | ||
Secondary | mortality | six month | ||
Secondary | Number of days of hospital stay | six month | ||
Secondary | Overall cost for patients in euros | six month |
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