Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reference Nurse Program for Pressure Ulcers in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01877681
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Cristina Quesada, Basque Health Service

Brief Summary:

Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.

Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.

Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used


Condition or disease Intervention/treatment Phase
Pressure Ulcers Procedure: Tele-assistance Procedure: Active comparator Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
Study Start Date : October 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: Assisted Care
Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application
Procedure: Tele-assistance
Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application

Active Comparator: Active comparator
Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment
Procedure: Active comparator
Usual care as specified in the PU practice guideline




Primary Outcome Measures :
  1. healing progression [ Time Frame: 8 weeks ]
    healing progression as measured by the RESVECH scale by a blinded expert



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)

Exclusion Criteria:

  • Patients with chronic wounds that are not PU
  • PU in patients with plastic surgery
  • Patients who move periodically
  • Patients requiring hospitalization during follow-up
  • Patients in which nurse is expected to be changed during follow-up
  • Terminal patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877681


Sponsors and Collaborators
Basque Health Service
Investigators
Layout table for investigator information
Principal Investigator: Cristina Quesada, Nurse Osakidetza

Layout table for additonal information
Responsible Party: Cristina Quesada, Nurse, Basque Health Service
ClinicalTrials.gov Identifier: NCT01877681     History of Changes
Other Study ID Numbers: 2011111099
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases