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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02447562

Enrollment

495

Registered

2015-05-19

Start date

2012-06-30

Completion date

2014-07-31

Last updated

2015-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

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.

Interventions

DEVICEPlatform NOMHADchronic

Intervention group with a health Platform NOMHADchronic

OTHERPhone-based care group

OTHERUsual care group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)	12 months

Secondary

Measure	Time frame
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
Change from Baseline HRQL	12 months
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
Adverse events causing ER visits or non-planned hospitalization	continous

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026