Evaluation the Effectiveness of a Telemonitoring Program in a Cohort of COPD Patient With Frequent Readmissions

NCT02528370 | Completed Results

• 1 other identifier: PI013/02352
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observational non-randomized study with an intervention cohort from Hospital Galdakao-Usansolo with 119 patients and a control cohort from Hospital Cruces with 78 patients. The inclusion criteria were: being hospital admitted at least twice in the previous year or at least three times in the 2 previous years. The cohorts were follow-up for 2 years. Several clinical measurements like pulmonary function, exercise capacity, health related quality of life, limitation in daily life activities and anxiety and depression were recorded in both cohorts. Telemonitoring and an organized education program were only and exclusively applied in the intervention cohort.

Conditions

COPD

Keywords

COPD exacerbation; Telemedicine; Intervention Studies; Patient Readmission

Outcome Measures

Primary Outcomes (1)

• Number of Hospitalizations for COPD Exacerbation (eCOPD)

  The primary outcome of the program was to diminish the rate of hospitalizations for eCOPD. We defined an exacerbation as a sustained worsening of the participant's COPD symptoms from their usual stable state that was beyond normal day-to-day variations, and with a severity level that need hospital admission to be solved.

  two years

Study Arms (2)

telEPOC

EXPERIMENTAL

The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.

Device: telEPOC

No telEPOC / Usual Care

NO INTERVENTION

The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months. Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control.

Interventions

telEPOC DEVICE

The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.

telEPOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Dr. Cristobal Esteban: lead
• Osakidetza: collaborator

Related Publications (5)

• Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, Lewis S, Stoddart A, van der Pol M, MacNee W, Sheikh A, Pagliari C, McKinstry B. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial. BMJ. 2013 Oct 17;347:f6070. doi: 10.1136/bmj.f6070.

  PMID: 24136634 BACKGROUND

• Bolton CE, Waters CS, Peirce S, Elwyn G; EPSRC and MRC Grand Challenge Team. Insufficient evidence of benefit: a systematic review of home telemonitoring for COPD. J Eval Clin Pract. 2011 Dec;17(6):1216-22. doi: 10.1111/j.1365-2753.2010.01536.x. Epub 2010 Sep 16.

  PMID: 20846317 BACKGROUND

• McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease: Cochrane Review and meta-analysis. Br J Gen Pract. 2012 Nov;62(604):e739-49. doi: 10.3399/bjgp12X658269.

  PMID: 23211177 BACKGROUND

• McLean S, Sheikh A, Cresswell K, Nurmatov U, Mukherjee M, Hemmi A, Pagliari C. The impact of telehealthcare on the quality and safety of care: a systematic overview. PLoS One. 2013 Aug 19;8(8):e71238. doi: 10.1371/journal.pone.0071238. eCollection 2013.

  PMID: 23977001 BACKGROUND

• Esteban C, Moraza J, Iriberri M, Aguirre U, Goiria B, Quintana JM, Aburto M, Capelastegui A. Outcomes of a telemonitoring-based program (telEPOC) in frequently hospitalized COPD patients. Int J Chron Obstruct Pulmon Dis. 2016 Nov 24;11:2919-2930. doi: 10.2147/COPD.S115350. eCollection 2016.

  PMID: 27920519 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our results could probably not be translated to other health systems. We will not be able establish which parts of the results are related to the every part of the program. The level of education of patients may play a role in the results.

Results Point of Contact

• Title: Dr Cristobal Esteban
• Organization: Hospital Galdakao-Usansolo

cristobal.estebangonzalez@osakidetza.eus

0034 94 400 7000

Study Officials

• Cristobal Esteban, MD

  Staff member

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only data entry people and biostatisticians were masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: May 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share