- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116451
Nurses' Foot Health and Work Well-being
Nurses' Foot Health and Work Well-being - Development and Testing of an Electronic Foot Health Program
Study Overview
Status
Intervention / Treatment
Detailed Description
An electronic Foot Health Promoting Program (FHPP) will be tested with nurses using quasi-experimental study design.
The participants will be assigned to experimental (N=130) and comparison (N=130) groups. The experimental group will receive an electronic intervention (Foot Health Promotion Program) for 8 weeks consisting of foot self-care guidance (skin and nail self-care), foot exercises, foot stretching and professional footwear guidance. Detailed components of the intervention will be produced on the bases of survey (part 1) results. The intervention (Figure 3) will be electronic via internet (Moodle platform) where a material package of foot health care will be delivered. Each participant will receive a user account to platform. The platform is divided into four main themes all related to foot health. Each theme consists of two topics of foot health. Each topic includes lectures (delivered via Adobe Presenter) and self-directed learning where participant will go through a list of links to websites (will be evaluated with certain criteria beforehand) and watch videos about foot self-care. In addition, the learning will be evaluated using four individual tasks related to foot self-care. By responding to task a participant will receive an example of the correct answer and using that he/she can evaluate own response and learn by that. Participants' use of different links (quantity) and their paths in the intervention platform will be calculated and analysed. The participants will be tested before the intervention (baseline) and one month (follow-up 1) and four (follow-up 2) months after the intervention. The primary outcome is foot health knowledge and secondary outcomes are foot health, musculoskeletal problems, work ability, health-related quality of life and work satisfaction. Hypothesis is: Increasing nurses' knowledge about foot health will improve their foot health and work ability. Ultimate goal is to develop tools for the occupational health care and improve the attention paid to feet as part of the work ability among nurses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Turku, Finland, 20520
- University of Turku
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- nurses (registered nurses, licensed practical nurses, public health nurses) working in the operating theatre
Exclusion Criteria:
- other health care professionals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Foot Health Promoting Program
The experimental group will receive an electronic intervention (Foot Health Promotion Program, FHPP) for 8 weeks consisting of foot self-care guidance (skin and nail self-care), foot exercises, foot stretching and professional footwear guidance.
Each topic includes lectures (delivered via Adobe Presenter) and self-directed learning where participant will go through a list of links to websites and watch videos about foot self-care.
In addition, the learning will be evaluated using four individual tasks related to foot self-care.
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An electronic intervention for 8 weeks consisting of foot self-care guidance targeted to nurses.
Other Names:
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No Intervention: Comparison group
The comparison group will not receive any instructions or guidance for foot self-care but participant in the comparison group will complete the same measurement points than experimental group.
After the study, the comparison group will also receive the same intervention than experimental group (if effective).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Foot self-care knowledge at 4 and 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
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Measured with Foot Self-Care Knowledge Questionnaire including 11 questions using a "true," "false," or "don't know" response options.
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baseline, 4 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Foot health at 4 and 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
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Self-reported foot health questionnaire (SFHQ) will be modified for this study.
It will measure self-reported foot health consisting of five subscales: skin, nails, foot structure, foot pain and professional footwear.
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baseline, 4 weeks, 12 weeks
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Change from Baseline Musculoskeletal Disorders at 4 and 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
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Nordic Questionnaire measures musculoskeletal disorders in neck, shoulders, upper back, elbows, low back, wrists/hands, hips/thighs, knees and ankles/feet.
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baseline, 4 weeks, 12 weeks
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Change from Baseline Foot health Status at 4 and 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
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Foot Health Status Questionnaire measures foot health related to quality of life.
There are 4 subscales: foot pain (4 questions), foot function (4 questions), footwear (3 questions), and general foot health (2 questions).
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baseline, 4 weeks, 12 weeks
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Change from Baseline Work Ability Score at 4 and 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
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Work Ability Score, assesses workers self-assessed work ability (one item with 0-10 scale)
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baseline, 4 weeks, 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Minna Stolt, PhD, University of Turku
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 116464
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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