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

NCT ID: NCT02447562

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

G_AH

Usual care group

Group Type: ACTIVE_COMPARATOR

Usual care group

Intervention Type: OTHER

G_SP

Phone-based care

Group Type: OTHER

Phone-based care group

Intervention Type: OTHER

G_NOMHAD

Intervention group with a health platform NOMHADchronic

Group Type: EXPERIMENTAL

Platform NOMHADchronic

Intervention Type: DEVICE

Intervention group with a health Platform NOMHADchronic

Interventions

Platform NOMHADchronic

Intervention group with a health Platform NOMHADchronic

Intervention Type: DEVICE

Phone-based care group

Intervention Type: OTHER

Usual care group

Intervention Type: OTHER

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

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)…)

• Minimum Eligible Age: 18 Years
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17132052 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19797277 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 29705155 (View on PubMed)

Other Identifiers

GECHRONIC

Identifier Type: -

Identifier Source: org_study_id