Chronic DiseaseNCT04957017
Effect of Hand-Washing Training in Covid-19
A study testing Training in people with Chronic Disease and Covid-19 Pandemic, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Covid-19 Pandemic
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 10 Jun 2021
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be women, agreeing to participate.
Who cannot join
- Be man, unable to communicate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Disease, Covid-19 Pandemic
- Being tested
- Training
- Keywords
- COVID-19, hand hygiene, chronic disease
- Medical subject headings
- Chronic Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Behavioral: Training |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nutritional Knowledge Level Scale for Adults (NKLSA)
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.
Measured: Three months
Social Hand-Washing Knowledge Form
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start15 Aug 2020
- Primary completion25 Jan 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Terkes, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957017
- Sponsor's protocol ID
- GO 2020/192
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is not plan.
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.
PubMed 33177864Cintoni 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. No abstract available.
PubMed 32253375
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Training on Given to Women With Chronic Disease on Hand-Washing Behaviours, Attitudes and Nutrition During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04957017
- Acronym / sponsor ID
- GO 2020/192
- Conditions
- Chronic Disease, Covid-19 Pandemic
- Keywords
- COVID-19, hand hygiene, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 9 Jul 2021 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: TrainingThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be women, agreeing to participate.
Key exclusion criteria (1 listed)
- Be man, unable to communicate.
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 |
|---|---|---|
| TrainingAfter 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 | Behavioural | Intervention group |
Primary outcome
The Nutritional Knowledge Level Scale for Adults (NKLSA)
Time frame: Three months
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.
Social Hand-Washing Knowledge Form
Time frame: Three months
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.
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 9 Jul 2021.
- Background: PubMed 33177864Geleta 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.
- Results publication: PubMed 32253375Cintoni 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. No abstract available.
- Individual participant dataSharing planned: Undecided. There is not plan.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Chronic Disease and Covid-19 Pandemic, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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 9 Jul 2021. 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 Turkey (Türkiye). 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?
The Nutritional Knowledge Level Scale for Adults (NKLSA) (time frame: Three months). The study lists 2 primary outcomes in all. 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 NCT04957017, which also lists 2 linked publications.
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 9 Jul 2021.