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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 510
- 试验地点
- 10
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tele-monitoring Constant
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.
干预措施: Telemonitoring Constant (Other)
Standard clinical care
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
干预措施: Standard clinical care (Other)
结局指标
主要结局
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
时间窗: Six month
Monitoring number of hospitalizations and/or number of emergency visits in the period.
次要结局
- Number of hospital admissions(six month)
- perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.(at 45 days and after 6 months of follow-up,)
- quality of life related to health, of follow-up in both arms of the clinical trial,(At the time of inclusion, at 45 days and after 6 months of follow-up.)
- To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.(six month)
- Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial(six month)
- mortality(six month)
- Overall cost for patients in euros(six month)
- quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.(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.(six month)
- Number of admissions-visits to Hospital Emergency(six month)
- Number of visits to Primary Care Emergencies(six month)
- Number of days of hospital stay(six month)