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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447562
• Other study ID #: GECHRONIC
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: May 14, 2015
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Device:
• Platform NOMHADchronic
Intervention group with a health Platform NOMHADchronic

Other:
• Phone-based care group

• Usual care group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

References & Publications (7)

Bengoa R, Nuño Solinís R (eds.). Curar y cuidar. Innovación en la gestión de enfermedades crónicas: una guía práctica para avanzar. Barcelona, Masson; 2008

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. — View Citation

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. — View 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.

World Health Organization. Global Report. Preventing Chronic Disease: a vital investment. WHO, Geneva; 2005.

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)		12 months	No
Secondary	Change from Baseline HRQL		12 months	No
Secondary	Health Related Quality of Life according to EuroQoL EVA		12 months	No
Secondary	Mortality		12 months	Yes
Secondary	Number of emergencies room visits		12 months	No
Secondary	Number of non-planned hospitalizations		12 months	No
Secondary	Adverse events causing ER visits or non-planned hospitalization		continous	Yes
Secondary	Health resources consumption according to total number of ER visits and non-planned hospitalizations		12 months	No
Secondary	Health direct costs using health resources consumption and unitary cost for each resource.		12 months	No
Secondary	Treatment satisfaction using an ad hoc Likert questionnaire		12 months	No