FootNCT03116451
Nurses' Foot Health and Work Well-being
A study testing Foot Health Promoting Program in people with Foot and Nurses, run by University of Turku at 1 site in Finland.
Trial summary
This study supports and promotes work well-being of nursing personnel from the perspective of foot health in health care organizations. Half of the participants will receive an electronic foot health education program to improve their foot self-care knowledge, while the other will receive anything. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Foot Health Promoting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2017to 31 Dec 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nurses (registered nurses, licensed practical nurses, public health nurses) working in the operating theatre
Who cannot join
- other health care professionals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurses' Foot Health and Work Well-being - Development and Testing of an Electronic Foot Health Program
This study supports and promotes work well-being of nursing personnel from the perspective of foot health in health care organizations. Half of the participants will receive an electronic foot health education program to improve their foot self-care knowledge, while the other will receive anything. The outcomes of this project include recommendations and tested educational program to occupational health care for improving foot health of nurses.
Read the 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.
- Being tested
- Foot Health Promoting Program
- Keywords
- foot health, nurses, work well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Health Promoting ProgramBehavioural
Also called FHPP
An electronic intervention for 8 weeks consisting of foot self-care guidance targeted to nurses.
| Study group | Role | What they receive |
|---|---|---|
| Foot Health Promoting Program | Experimental | 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. Receives: Behavioral: Foot Health Promoting Program |
| Comparison group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Foot self-care knowledge at 4 and 12 weeks
Measured with Foot Self-Care Knowledge Questionnaire including 11 questions using a "true," "false," or "don't know" response options.
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (4)
Change from Baseline Foot health at 4 and 12 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
Change from Baseline Musculoskeletal Disorders at 4 and 12 weeks
Nordic Questionnaire measures musculoskeletal disorders in neck, shoulders, upper back, elbows, low back, wrists/hands, hips/thighs, knees and ankles/feet.
Measured: baseline, 4 weeks, 12 weeks
Change from Baseline Foot health Status at 4 and 12 weeks
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).
Measured: baseline, 4 weeks, 12 weeks
Change from Baseline Work Ability Score at 4 and 12 weeks
Work Ability Score, assesses workers self-assessed work ability (one item with 0-10 scale)
Measured: baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Jan 2017
- Primary completion29 Nov 2017
- Study completion31 Dec 2017
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 FootStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Quasi-experimental study design
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Work Environment Fund, Turku University Hospital
- Responsible party
- Principal investigator, Minna Stolt, University of Turku
- Investigators
- Minna Stolt, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116451
- Sponsor's protocol ID
- 116464
- Status last verified
- May 2018
- First submitted
- 5 Apr 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stolt M, Katajisto J, Peltonen J, Suhonen R, Leino-Kilpi H. Development and testing of a new electronic foot health promotion programme on nurses' foot self-care. BMC Nurs. 2020 Apr 19;19:29. doi: 10.1186/s12912-020-00423-z. eCollection 2020.
PubMed 32327936
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses' Foot Health and Work Well-being - Development and Testing of an Electronic Foot Health Program
- ClinicalTrials.gov ID
- NCT03116451
- Acronym / sponsor ID
- 116464
- Keywords
- foot health, nurses, work well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Finnish Work Environment Fund, Turku University Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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.
This study supports and promotes work well-being of nursing personnel from the perspective of foot health in health care organizations. Half of the participants will receive an electronic foot health education program to improve their foot self-care knowledge, while the other will receive anything. The outcomes of this project include recommendations and tested educational program to occupational health care for improving foot health of nurses.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study design
| Arm | Type | Receives |
|---|---|---|
| Foot Health Promoting Program | Experimental | Behavioral: Foot Health Promoting ProgramThe 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. |
| Comparison group | No intervention | –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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nurses (registered nurses, licensed practical nurses, public health nurses) working in the operating theatre
Key exclusion criteria (1 listed)
- other health care professionals
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 |
|---|---|---|
| Foot Health Promoting ProgramAlso: FHPPAn electronic intervention for 8 weeks consisting of foot self-care guidance targeted to nurses. | Behavioural | Foot Health Promoting Program |
Primary outcome
Change from Baseline Foot self-care knowledge at 4 and 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Measured with Foot Self-Care Knowledge Questionnaire including 11 questions using a "true," "false," or "don't know" response options.
4 secondary outcomes
Change from Baseline Foot health at 4 and 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change from Baseline Musculoskeletal Disorders at 4 and 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change from Baseline Foot health Status at 4 and 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change from Baseline Work Ability Score at 4 and 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 32327936Stolt M, Katajisto J, Peltonen J, Suhonen R, Leino-Kilpi H. Development and testing of a new electronic foot health promotion programme on nurses' foot self-care. BMC Nurs. 2020 Apr 19;19:29. doi: 10.1186/s12912-020-00423-z. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Minna Stolt, PhD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Health Promoting Program in people with Foot and Nurses, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Foot self-care knowledge at 4 and 12 weeks (time frame: baseline, 4 weeks, 12 weeks). 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 NCT03116451, 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 3 May 2018.