NCT02224300

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.
  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

August 9, 2014

Last Update Submit

August 22, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, Week 8 and Week 12

Secondary Outcomes (4)

  • Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education

    Baseline, Week 8 and Week 12

  • Changes in clinical variables; venous leg ulcer size.

    Baseline, Week 8 and Week 12

  • Changes in clinical variables; adequacy of the supplies used.

    Baseline, Week 8 and Week 12

  • Changes in economical variables cost of supplies and treatment time.

    Baseline, Week 8 and Week 12

Study Arms (1)

Education

EXPERIMENTAL

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

Interventions

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.

Education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Home health-care patient aged 60 or over
  • Venous leg ulcer diagnosis
  • Chronic ulcer in the lower leg without diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Homecare

Turku, Finland

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Minna S Ylönen, PhD-candidate

CONTACT

Minna Ylönen, PhD-candidate

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

August 9, 2014

First Posted

August 25, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations