- Venous Leg UlcersPhase 2NCT02224300
Nursing Care With Patients With Venous Leg Ulcers
A Phase 2 study testing Internet-based education of venous leg ulcer nursing care in people with - Venous Leg Ulcers, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- - Venous Leg Ulcers
- What is being tested?
- Internet-based education of venous leg ulcer nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Home health-care patient aged 60 or over
- Venous leg ulcer diagnosis
- Chronic ulcer in the lower leg without diagnosis
Who cannot join
- 1. Working in other place than home-care There are no other exclusion criteria.
- 1. An ulcer with other diagnosis than venous leg ulcer diagnosis There are no other exclusion criteria for patients.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Homecare
Turku
Johanna Ritvanen, MNSc, johanna.ritvanen@turku.fi
Minna Ylönen, PhD (c)
About this study
Official title: 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
Read more
Research questions are:
- 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.
- 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.
- What are the economical outcomes (treatment time and supply usage) of ELC?
Hypothesis for research question 3 is:
- 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.
Read the 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.
- Conditions
- - Venous Leg Ulcers
- Being tested
- Internet-based education of venous leg ulcer nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based education of venous leg ulcer nursing careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Internet-based education of venous leg ulcer nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 8 and Week 12
Secondary outcomes (4)
Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education
Changes in attitudes will be measured with structured questionnaire.
Measured: Baseline, Week 8 and Week 12
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.
Measured: Baseline, Week 8 and Week 12
Changes in clinical variables; adequacy of the supplies used.
Changes in adequacy of supplies used will be measured with structured observation.
Measured: Baseline, Week 8 and Week 12
Changes in economical variables cost of supplies and treatment time.
Changes in economical variables will be measured with structured observation.
Measured: Baseline, Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for - Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minna Ylönen, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224300
- Sponsor's protocol ID
- LAPHOI
- Status last verified
- Aug 2014
- First submitted
- 9 Aug 2014
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25976713
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Care With Patients With Venous Leg Ulcers - Developing an Internet-based Education Program and Evaluation of Its Effectiveness
- ClinicalTrials.gov ID
- NCT02224300
- Acronym / sponsor ID
- LAPHOI
- Conditions
- - Venous Leg Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- What are the economical outcomes (treatment time and supply usage) of ELC?
Hypothesis for research question 3 is:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Internet-based education of venous leg ulcer nursing careIntervention 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Home health-care patient aged 60 or over
- Venous leg ulcer diagnosis
Key exclusion criteria (2 listed)
- 1. Working in other place than home-care There are no other exclusion criteria.
- 1. An ulcer with other diagnosis than venous leg ulcer diagnosis There are no other exclusion criteria for patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based education of venous leg ulcer nursing careIntervention 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. | Behavioural | Education |
Primary outcome
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).
4 secondary outcomes
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 clinical variables; venous leg ulcer size.
Time frame: 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 economical variables cost of supplies and treatment time.
Time frame: Baseline, Week 8 and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Derived from this study: PubMed 25976713Ylonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Internet-based education of venous leg ulcer nursing care in people with - Venous Leg Ulcers, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minna S Ylönen, PhD-candidate (+358400667809, misuyl@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nurses´ knowledge before and after the education (time frame: Baseline, Week 8 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.