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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
495

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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