Clinical trial NCT02447562: Model for the Integral Assessment of Chronic Disease Management Supported in Information Technology and Communication.
Official title: A Randomized Clinical Trial to Investigate the Management for the Integral Assessment Model of Chronic Disease Supported in Information Technology and Communication.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 495
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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)...)

Primary outcomes:
measure: Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline HRQL
timeFrame: 12 months
measure: Health Related Quality of Life according to EuroQoL EVA
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Number of emergencies room visits
timeFrame: 12 months
measure: Number of non-planned hospitalizations
timeFrame: 12 months
measure: Adverse events causing ER visits or non-planned hospitalization
timeFrame: continous
measure: Health resources consumption according to total number of ER visits and non-planned hospitalizations
timeFrame: 12 months
measure: Health direct costs using health resources consumption and unitary cost for each resource.
timeFrame: 12 months
measure: Treatment satisfaction using an ad hoc Likert questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Pomerleau J, Knai C, Nolte E. The burden of chronic disease in Europe. In: Nolte E, McKee M (eds.). Caring for people with chronic conditions: A health system perspective. Maidenhead, Open University Press; 2008.
citation: Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
citation: World Population Ageing, 1950-2050, (publicación de las Naciones Unidas, número de venta: E.02.XIII.3) y World Population Ageing, 2007 (publicación de las Naciones Unidas, número de venta: E.07.XIII.5
citation: World Health Organization: Innovative care for chronic conditions: building blocks for action. WHO, Geneva; 2002. Disponible en: http://publications.paho.org/product.php?productid=837&cat=0&page=1 [acceso Enero, 2012
citation: World Health Organization. Global Report. Preventing Chronic Disease: a vital investment. WHO, Geneva; 2005.
citation: Bodenheimer T, Berry-Millett R. Follow the money--controlling expenditures by improving care for patients needing costly services. N Engl J Med. 2009 Oct 15;361(16):1521-3. doi: 10.1056/NEJMp0907185. Epub 2009 Sep 30. No abstract available.
citation: Bengoa R, Nuño Solinís R (eds.). Curar y cuidar. Innovación en la gestión de enfermedades crónicas: una guía práctica para avanzar. Barcelona, Masson; 2008
citation: Valdivieso B, Garcia-Sempere A, Sanfelix-Gimeno G, Faubel R, Librero J, Soriano E, Peiro S; GeChronic Group. The effect of telehealth, telephone support or usual care on quality of life, mortality and healthcare utilization in elderly high-risk patients with multiple chronic conditions. A prospective study. Med Clin (Barc). 2018 Oct 23;151(8):308-314. doi: 10.1016/j.medcli.2018.03.013. Epub 2018 Apr 25. English, Spanish.