Model for the Integral Assessment of Chronic Disease Management Supported in Information Technology and Communication.
Not Applicable
Completed
- Conditions
- Chronic Disease
- Interventions
- Other: Usual care groupOther: Phone-based care groupDevice: Platform NOMHADchronic
- Registration Number
- NCT02447562
- Lead Sponsor
- Instituto de Investigacion Sanitaria La Fe
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 495
Inclusion Criteria
- 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 exclusion criteria
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)...)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G_AH Usual care group Usual care group G_SP Phone-based care group Phone-based care G_NOMHAD Platform NOMHADchronic Intervention group with a health platform NOMHADchronic
- Primary Outcome Measures
Name Time Method Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) 12 months
- Secondary Outcome Measures
Name Time Method 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