Model for the Integral Assessment of Chronic Disease Management Supported in Information Technology and Communication.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial to Investigate the Management for the Integral Assessment Model of Chronic Disease Supported in Information Technology and Communication.

Conditions
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Chronic Disease

Intervention / Treatment
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* Device: Platform NOMHADchronic
* Other: Phone-based care group
* Other: Usual care group


Participation Criteria
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Eligibility Criteria
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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)…)

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G_AH<br>Usual care group | Other: Usual care group<br> <br> |
| Other: G_SP<br>Phone-based care | Other: Phone-based care group<br> <br> |
| Experimental: G_NOMHAD<br>Intervention group with a health platform NOMHADchronic | Device: Platform NOMHADchronic<br>* Intervention group with a health Platform NOMHADchronic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HRQL |  | 12 months | 
| Health Related Quality of Life according to EuroQoL EVA |  | 12 months | 
| Mortality |  | 12 months | 
| Number of emergencies room visits |  | 12 months | 
| Number of non-planned hospitalizations |  | 12 months | 
| Adverse events causing ER visits or non-planned hospitalization |  | continous | 
| Health resources consumption according to total number of ER visits and 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 |