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Completed

NCT Number: NCT02447562

Model for the Integral Assessment of Chronic Disease Management 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.

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Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)…)

Treatment and study plan

Platform NOMHADchronic

Device

Intervention group with a health Platform NOMHADchronic

Phone-based care group

Other

Usual Care Group

Other

Primary outcomes

  1. Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)

    Time frame: 12 months

Secondary outcomes

  1. Change from Baseline HRQL

    Time frame: 12 months

  2. Health Related Quality of Life according to EuroQoL EVA

    Time frame: 12 months

  3. Mortality

    Time frame: 12 months

  4. Number of emergencies room visits

    Time frame: 12 months

  5. Number of non-planned hospitalizations

    Time frame: 12 months

  6. Adverse events causing ER visits or non-planned hospitalization

    Time frame: continous

  7. Health resources consumption according to total number of ER visits and non-planned hospitalizations

    Time frame: 12 months

  8. Health direct costs using health resources consumption and unitary cost for each resource.

    Time frame: 12 months

  9. Treatment satisfaction using an ad hoc Likert questionnaire

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 19, 2015
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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