Clinical trial NCT02224300: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: - Venous Leg Ulcers
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in nurses´ knowledge before and after the education
timeFrame: Baseline, Week 8 and Week 12
Secondary outcomes:
measure: Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education
timeFrame: Baseline, Week 8 and Week 12
measure: Changes in clinical variables; venous leg ulcer size.
timeFrame: Baseline, Week 8 and Week 12
measure: Changes in clinical variables; adequacy of the supplies used.
timeFrame: Baseline, Week 8 and Week 12
measure: Changes in economical variables cost of supplies and treatment time.
timeFrame: Baseline, Week 8 and Week 12
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Homecare
Study officials:
References:
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.