Nursing Care With Patients With Venous Leg Ulcers

August 22, 2014 updated by: Minna Ylönen, University of Turku

Nursing Care With Patients With Venous Leg Ulcers - Developing an Internet-based Education Program and Evaluation of Its Effectiveness

Aims are:

  • develop an Internet-based education programme about venous leg ulcer nursing care (ELC)
  • evaluate the clinical, cognitive and economical outcomes of education programme

Research questions are:

1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg ulcer nursing care, theoretical knowledge level and practical knowledge)?

Hypotheses for research question 1 are:

  1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical knowledge) than those who will not use the ELC.
  2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing care than those who will not use the ELC.

2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?

Hypotheses for research question 2 are:

  1. Ulcer healing progresses better among patients who are taken care by nurses using the ELC.
  2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.
  3. Nurses using the ELC will use mire adequate treatment supplies than those who will not use the ELC.

3. What are the economical outcomes (treatment time and supply usage) of ELC?

Hypothesis for research question 3 is:

1. The economical expenditures will be lower among nurses using the ELC.

The ultimate aim is to promote evidence-based nursing care among patients with venous leg ulcer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study takes place in home-care in two Finnish municipality, which are similar size and staff structure and working ideology are basically the same.

Enrolment of participants has started with information occasion in both municipalities in June 2014. Nurses were asked to fill the Patients Clinical Situation Questionnaire, handouts and forms for informed consent were delivered. (Figure 1) All eligible nurses and patients will be identified with Patient Clinical Assessment. The sample size was determined with power analysis and the result was that 200 nurses are needed in the intervention group and 100 nurses in the comparison group.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Minna S Ylönen, PhD-candidate
  • Phone Number: +358400667809
  • Email: misuyl@utu.fi

Study Contact Backup

  • Name: Minna Ylönen, PhD-candidate
  • Phone Number: +358400667809
  • Email: misuyl@utu.fi

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria for nurses:

  1. Working in municipality home-care
  2. Permanent attachment or three months or longer temporary post in municipality home-care
  3. Working in home-care area where patients with chronic leg ulcer are taken care during the study

Exclusion criteria for nurses:

1. Working in other place than home-care There are no other exclusion criteria.

Inclusion criteria for patients to observation are:

  1. Home health-care patient aged 60 or over
  2. Venous leg ulcer diagnosis
  3. Chronic ulcer in the lower leg without diagnosis

Exclusion criteria for patients:

1. An ulcer with other diagnosis than venous leg ulcer diagnosis There are no other exclusion criteria for patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education

Intervention group will receive the ELC for six weeks (15.9. - 26.10.2014) and comparison group will not receive it.

Members of the intervention group in will work in teams of 10 nurses with weekly questions (released in Mondays) based on patient-description existing in Moodle. One member of the team will send the solutions to questions once a week (in Thursdays) Moodle. Researcher will download the model-answer to Moodle once a week (in Fridays) and nurses will compare their answer to model answer (self-evaluation).
Behavioral: Internet-based education of venous leg ulcer nursing care
Intervention is delivering the ELC (Electronic Learning of venous leg ulcer nursing care) to home health-care nurses (registered nurses, public health nurses and licensed practical nurses) . The ELC development was based on the integrative literature review about nurses' knowledge gaps on venous leg ulcer nursing care. The pedagogical basis of the ELC is constructivism and blended learning approach. The ELC comprises contact learning and distance learning. Content of ELC is evidence-based information already existing in Internet and the basis of the information is the Finnish Current Care Guidelines for Chronic leg ulcers (2014), which are evidence-based clinical practice guidelines. They are intended as basis for ulcer treatment decisions, and guidelines can be used by nurses and other healthcare professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in nurses´ knowledge before and after the education
Time Frame: Baseline, Week 8 and Week 12

Knowledge is divided into nurses´ perceived knowledge, practical and theoretical knowledge.

Changes in perceived knowledge will be measured with structured self-completed questionnaire.

Changes in practical knowledge will be measured with structured observation. Changes in theoretical knowledge will be measured with structured questionnaire (knowledge-test).
Baseline, Week 8 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education
Time Frame: Baseline, Week 8 and Week 12
Changes in attitudes will be measured with structured questionnaire.
Baseline, Week 8 and Week 12
Changes in clinical variables; venous leg ulcer size.
Time Frame: Baseline, Week 8 and Week 12
Changes in venous leg sizes variables will be measured during observations. Each venous leg ulcer will measured with paper ruler.
Baseline, Week 8 and Week 12
Changes in clinical variables; adequacy of the supplies used.
Time Frame: Baseline, Week 8 and Week 12
Changes in adequacy of supplies used will be measured with structured observation.
Baseline, Week 8 and Week 12
Changes in economical variables cost of supplies and treatment time.
Time Frame: Baseline, Week 8 and Week 12
Changes in economical variables will be measured with structured observation.
Baseline, Week 8 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 9, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAPHOI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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