NCT02447562已完成不适用
A Randomized Clinical Trial to Investigate the Management for the Integral Assessment Model of Chronic Disease Supported in Information Technology and Communication.
Instituto de Investigacion Sanitaria La Fe0 个研究点目标入组 495 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 495
- 主要终点
- Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)
研究概览
简要总结
Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a health platform NOMHADchronic, phone-based care group, usual care group) developed in the Valencia La Fe Health Department. 495 high-complexity chronic patients will be included according to a combined recruitment based on a risk predictive model plus clinical opinion. Patients will be followed-up during 12 months in order to evaluate health-related quality of life, mortality, health consumption, health direct cost and treatment satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •High complexity: according to a combined criteria a) predictive model of Valencia La Fe Health department for hospital resources consumption in next 12 months (probability >95%) and b) risk confirmation by a clinical team with experience on chronic patients management.
- •Participants that accept to participate in the study by the informed consent signature
- •Participants that don't meet any of the
排除标准
- •Exclusion Criteria:
- •Age <18 años.
- •Participants with cognitive or sensorial difficulties or with insufficient knowledge of one of the 2 official languages of Valencian Community that, according to the healthcare professional, may affect their study participation.
- •No residents or temporary residents in the Health Department
- •Homeless or participants with high-risk of social exclusion.
- •Terminal patients or in palliative care according to the SECPAL (Spanish Society of Palliative Care) criteria .
- •Community-dwelling patients
- •Inability for mobile phone management if there is a caregiver with this capability.
- •Participants without a phone line
- •Non high-complexity chronic patients according to the recruitment healthcare professional.
- •Members of the research team, workers related to the centers implied in the study or any other person directly involved in the study -
- •First degree consanguinity or similar affinity with the team members.
- •Participants already involved in case management.
- •Participants already participating in clinical trials or experimental trials.
- •Participants that don't accept to participate in the study or not signing the informed consent
- •Participants with a main diagnostic of mental diseases
- •Participants with active oncological diagnosis
- •Participants already following specific interventions for hemodialysis, organ transplanting, day hospital
- •Participants with an infectious chronic disease as unique chronic disease (HIV, BHV (Hepatitis B Virus)…)
研究组 & 干预措施
G_AH
Active Comparator
Usual care group
干预措施: Usual care group (Other)
G_SP
Other
Phone-based care
干预措施: Phone-based care group (Other)
G_NOMHAD
Experimental
Intervention group with a health platform NOMHADchronic
干预措施: Platform NOMHADchronic (Device)
结局指标
主要结局
Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)
时间窗: 12 months
次要结局
- Health Related Quality of Life according to EuroQoL EVA(12 months)
- Number of emergencies room visits(12 months)
- Adverse events causing ER visits or non-planned hospitalization(continous)
- Mortality(12 months)
- Change from Baseline HRQL(12 months)
- Number of non-planned hospitalizations(12 months)
- Health direct costs using health resources consumption and unitary cost for each resource.(12 months)
- Treatment satisfaction using an ad hoc Likert questionnaire(12 months)
- Health resources consumption according to total number of ER visits and non-planned hospitalizations(12 months)
研究者
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