NCT02447562

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

May 11, 2015

Last Update Submit

May 14, 2015

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (9)

  • Change from Baseline HRQL

    12 months

  • 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

  • +4 more secondary outcomes

Study Arms (3)

G_AH

ACTIVE COMPARATOR

Usual care group

Other: Usual care group

G_SP

OTHER

Phone-based care

Other: Phone-based care group

G_NOMHAD

EXPERIMENTAL

Intervention group with a health platform NOMHADchronic

Device: Platform NOMHADchronic

Interventions

Platform NOMHADchronicDEVICE

Intervention group with a health Platform NOMHADchronic

G_NOMHAD
Phone-based care groupOTHER
G_SP
Usual care groupOTHER
G_AH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    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.

    PMID: 17132052BACKGROUND

  • 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

    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

    BACKGROUND

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

    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.

    PMID: 19797277BACKGROUND

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

    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.

    PMID: 29705155DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 19, 2015

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 19, 2015

Record last verified: 2015-05