- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957017
Effect of Hand-Washing Training in Covid-19
July 7, 2021 updated by: Nurten Terkes, Mehmet Akif Ersoy University
Effect of Training on Given to Women With Chronic Disease on Hand-Washing Behaviours, Attitudes and Nutrition During the Covid-19 Pandemic
This study was conducted in order to inform, the women with chronic disease in rural areas, about hand-washing and nutrition, and to evaluate the efficiency of the training program.
A randomized-controlled trial was performed based on CONSORT checklist.
90 women in total were included in the study, 45 for each group.
The women in the intervention group were given, by the researcher, the training on the importance of hand-washing and appropriate food choices.
The training given to the women in rural areas created significant benefit for them to have the appropriate food choices and hand-washing behaviours.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Burdur, Turkey
- Burdur Mehmet Akif Ersoy University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Be women, agreeing to participate.
Exclusion Criteria:
- Be man, unable to communicate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention group
The women with chronic disease were met, and the Descriptive Information Form, Social Hand-Washing Knowledge Form and the "Nutritional Knowledge Level Scale for Adults" were filled with the volunteer ones face-to-face at their homes, complying with the social distance rules before the training.
After the data was collected, the women in the intervention group were trained on "Hand-Washing and Nutrition during the COVID-19 period".
The training on hand-washing and nutrition was given using the "Hand-Washing and Nutrition Training Guide" prepared by the researchers, and the "Hand-Washing and Nutrition Training Manual" covering the content of the training, was distributed to the women at the end of the training.
The data collection forms were re-filled three months after the training.
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After the data was collected, the women in the intervention group were trained on "Hand-Washing and Nutrition during the COVID-19 period".
The training on hand-washing and nutrition was given using the "Hand-Washing and Nutrition Training Guide" prepared by the researchers, and the "Hand-Washing and Nutrition Training Manual" covering the content of the training, was distributed to the women at the end of the training
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No Intervention: Control group
The women with chronic disease were met, and the Descriptive Information Form, Social Hand-Washing Knowledge Form and the Nutritional Knowledge Level Scale for Adults were filled face-to-face at their homes with the ones volunteering to participate in the study, complying with the social distance rules.
The same survey was re-filled after three months.
No training was given to the women with chronic disease during the three-month period.
After the research was completed, a 45 minute-training which is the same with the one provided to the intervention group was given individually to the control group, complying the social distance rules.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Nutritional Knowledge Level Scale for Adults (NKLSA)
Time Frame: Three months
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The Nutritional Knowledge Level Scale for Adults (NKLSA) developed by Batmaz in 2018 and whose validity and reliability were studied, the 20 statements under the heading "Basic Nutritional and Food-Health Knowledge" and 12 statements under the heading "Food Choice" were responded using one of the following: strongly agree, agree, neither agree nor disagree, disagree, and strongly disagree.
The participants who responded the inappropriate statements by "strongly agree" got 0 point; those who "agreed" with these statements got 1 point; those who neither agreed nor disagreed got 2 points; those who disagreed got 3 points, and those who strongly disagreed with them got 4 points.
The maximum score that can be obtained from the "Basic Nutritional and Food-Health Knowledge" is 80, and the maximum score to be obtained from the "Food Choice" is 48.
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Three months
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Social Hand-Washing Knowledge Form
Time Frame: Three months
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Social Hand-Washing Knowledge Form was created by the researchers by scanning the literature (Kilpatrick et al., 2018; Lynch et al., 2020; Wu et al., 2013), and the authors received expert opinions from 3 academic members for the content validity of the knowledge statements.
The answers given to the questions were scored as No "0", Occasionally "1", Yes "2".
Question 11 included in the investigators survey was reversely scored.
The lowest score to be obtained from the investigators survey was 0 and the highest score was 22.
As the investigators considered it more comprehensible to convert this score into a hundred scale and make the investigators evaluations over 100 points, the investigators evaluated the total score obtained by each case through converting it into a hundred scale.
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Three months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Geleta TA, Deriba BS, Beyane RS, Mohammed A, Birhanu T, Jemal K. COVID-19 Pandemic Preparedness and Response of Chronic Disease Patients in Public Health Facilities. Int J Gen Med. 2020 Nov 5;13:1011-1023. doi: 10.2147/IJGM.S279705. eCollection 2020.
- Cintoni M, Rinninella E, Annetta MG, Mele MC. Nutritional management in hospital setting during SARS-CoV-2 pandemic: a real-life experience. Eur J Clin Nutr. 2020 May;74(5):846-847. doi: 10.1038/s41430-020-0625-4. Epub 2020 Apr 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2020
Primary Completion (Actual)
January 25, 2021
Study Completion (Actual)
June 10, 2021
Study Registration Dates
First Submitted
July 4, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 9, 2021
Study Record Updates
Last Update Posted (Actual)
July 9, 2021
Last Update Submitted That Met QC Criteria
July 7, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 2020/192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
There is not plan.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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