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

May 14, 2015 updated by: Instituto de Investigacion Sanitaria La Fe

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

495

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 12 months
12 months
Change from Baseline HRQL
Time Frame: 12 months
12 months
Health Related Quality of Life according to EuroQoL EVA
Time Frame: 12 months
12 months
Number of emergencies room visits
Time Frame: 12 months
12 months
Number of non-planned hospitalizations
Time Frame: 12 months
12 months
Adverse events causing ER visits or non-planned hospitalization
Time Frame: continous
continous
Health resources consumption according to total number of ER visits and non-planned hospitalizations
Time Frame: 12 months
12 months
Health direct costs using health resources consumption and unitary cost for each resource.
Time Frame: 12 months
12 months
Treatment satisfaction using an ad hoc Likert questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECHRONIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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