NCT02499068

Brief Summary

The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period The primary endpoint of effectiveness is "severe exacerbations avoided." The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

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

December 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

March 20, 2015

Last Update Submit

August 2, 2019

Conditions

COPDDisease Progression

Outcome Measures

Primary Outcomes (1)

  • Number of hospitalizations due to exacerbation of COPD avoided

    1 year

Secondary Outcomes (3)

  • Cost-efficiency of treatment

    1 year

  • Cost-utility of treatment

    1 year

  • satisfaction of both patients and clinician responsibility questionnaire

    1 year

Study Arms (2)

COPD, Telehealth

EXPERIMENTAL

Patients randomized to this arm would be followed by home telehealth devices and monitored on a daily bases for early detection of exacerbations and prompt clinical intervention.

Device: Telehealth

COPD, Normal clinical practice

NO INTERVENTION

Patients would do the usual clinical practice.

Interventions

TelehealthDEVICE

Monitoring devices installed at patients home and patients are monitored on a daily bases for early detection of exacerbations and prompt clinical intervention.and being follow-up on a daily bases for early detection and prompt intervention.

Also known as: Telemedicine
COPD, Telehealth

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 50 and under 90 years of age.
  • Being diagnosed with COPD according to the criteria of GesEPOC, with severe airflow obstruction defined as a forced expiratory volume in one second (FEV1) less than 50% of theoretical.
  • "Exacerbator phenotype" defined as COPD patients having two or more moderate or severe exacerbations per year (GesEPOC guide). These exacerbations should be separated by at least 4 weeks after the end of previous treatment or 6 weeks from the start in cases that have not been treated
  • Clinically stable condition, defined as 6 weeks without clinical symptoms since the last exacerbation of COPD.
  • Having home oxygen therapy.
  • Sign the informed consent.

You may not qualify if:

  • Inability of the patient or caregiver to understand the procedure of Telehealth program.
  • Have a life expectancy of less than one year.
  • Have terminal heart failure (NYHA functional class III-IV).
  • Having advanced renal insufficiency (creatinine clearance \<30%) or be on dialysis program.
  • Have liver cirrhosis or be included in a program of liver transplantation.
  • Be institutionalized or in Residential hospice care.
  • Having a mini-mental test-score less than 24, because this score suggests dementia
  • To be considered by your doctor as not comply the treatment or monitoring required by their lung disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Rey Juan Carlos

Madrid, 28933, Spain

Location

Related Publications (2)

  • Segrelles Calvo G, Gomez-Suarez C, Soriano JB, Zamora E, Gonzalez-Gamarra A, Gonzalez-Bejar M, Jordan A, Tadeo E, Sebastian A, Fernandez G, Ancochea J. A home telehealth program for patients with severe COPD: the PROMETE study. Respir Med. 2014 Mar;108(3):453-62. doi: 10.1016/j.rmed.2013.12.003. Epub 2013 Dec 16.

    PMID: 24433744BACKGROUND

  • Ancochea J, Garcia-Rio F, Vazquez-Espinosa E, Hernando-Sanz A, Lopez-Yepes L, Galera-Martinez R, Peces-Barba G, Perez-Warnisher MT, Segrelles-Calvo G, Zamarro C, Gonzalez-Ponce P, Ramos MI, Conforto JI, Jafri S, Soriano JB. Efficacy and costs of telehealth for the management of COPD: the PROMETE II trial. Eur Respir J. 2018 May 30;51(5):1800354. doi: 10.1183/13993003.00354-2018. Print 2018 May. No abstract available.

    PMID: 29599185DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDisease Progression

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julio Ancochea Bermúdez, MD, PhD

    Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fundación Teófilo Hernando

Study Record Dates

First Submitted

March 20, 2015

First Posted

July 15, 2015

Study Start

December 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

ES(5)