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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01877681
Other study ID # 2011111099
Secondary ID
Status Completed
Phase Phase 2
First received June 12, 2013
Last updated April 15, 2015
Start date October 2012
Est. completion date September 2014

Study information

Verified date April 2015
Source Basque Health Service
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Tele-assistance
Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application
Active comparator
Usual care as specified in the PU practice guideline

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basque Health Service

Outcome

Type Measure Description Time frame Safety issue
Primary healing progression healing progression as measured by the RESVECH scale by a blinded expert 8 weeks No
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