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Nursing Care With Patients With Venous Leg Ulcers

Primary Purpose

- Venous Leg Ulcers

Status
Unknown status
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Internet-based education of venous leg ulcer nursing care
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for - Venous Leg Ulcers

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HomecareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Education

Arm Description

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).

Outcomes

Primary Outcome Measures

Changes in nurses´ knowledge before and after the education
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).

Secondary Outcome Measures

Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education
Changes in attitudes will be measured with structured questionnaire.
Changes in clinical variables; venous leg ulcer size.
Changes in venous leg sizes variables will be measured during observations. Each venous leg ulcer will measured with paper ruler.
Changes in clinical variables; adequacy of the supplies used.
Changes in adequacy of supplies used will be measured with structured observation.
Changes in economical variables cost of supplies and treatment time.
Changes in economical variables will be measured with structured observation.

Full Information

First Posted
August 9, 2014
Last Updated
August 22, 2014
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT02224300
Brief Title
Nursing Care With Patients With Venous Leg Ulcers
Official Title
Nursing Care With Patients With Venous Leg Ulcers - Developing an Internet-based Education Program and Evaluation of Its Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: Nurses using the ELC will have better knowledge (perceived, practical and theoretical knowledge) than those who will not use the ELC. 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: Ulcer healing progresses better among patients who are taken care by nurses using the ELC. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
- Venous Leg Ulcers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Internet-based education of venous leg ulcer nursing care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in nurses´ knowledge before and after the education
Description
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).
Time Frame
Baseline, Week 8 and Week 12
Secondary Outcome Measure Information:
Title
Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education
Description
Changes in attitudes will be measured with structured questionnaire.
Time Frame
Baseline, Week 8 and Week 12
Title
Changes in clinical variables; venous leg ulcer size.
Description
Changes in venous leg sizes variables will be measured during observations. Each venous leg ulcer will measured with paper ruler.
Time Frame
Baseline, Week 8 and Week 12
Title
Changes in clinical variables; adequacy of the supplies used.
Description
Changes in adequacy of supplies used will be measured with structured observation.
Time Frame
Baseline, Week 8 and Week 12
Title
Changes in economical variables cost of supplies and treatment time.
Description
Changes in economical variables will be measured with structured observation.
Time Frame
Baseline, Week 8 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for nurses: Working in municipality home-care Permanent attachment or three months or longer temporary post in municipality home-care 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: Home health-care patient aged 60 or over Venous leg ulcer diagnosis 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minna S Ylönen, PhD-candidate
Phone
+358400667809
Email
misuyl@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Minna Ylönen, PhD-candidate
Phone
+358400667809
Email
misuyl@utu.fi
Facility Information:
Facility Name
Homecare
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Ritvanen, MNSc
Email
johanna.ritvanen@turku.fi
First Name & Middle Initial & Last Name & Degree
Minna Ylönen, PhD (c)

12. IPD Sharing Statement

Citations:
PubMed Identifier
25976713
Citation
Ylonen M, Viljamaa J, Isoaho H, Junttila K, Leino-Kilpi H, Suhonen R. Effectiveness of an Internet-based learning program on venous leg ulcer nursing care in home health care--study protocol. J Adv Nurs. 2015 Oct;71(10):2413-25. doi: 10.1111/jan.12683. Epub 2015 May 14.
Results Reference
derived

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Nursing Care With Patients With Venous Leg Ulcers

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