NCT04957017

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 4, 2021

Last Update Submit

July 7, 2021

Conditions

Keywords

COVID-19hand hygienechronic disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Three months

Study Arms (2)

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.

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.

Interventions

TrainingBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be women, agreeing to participate.

You may not qualify if:

  • Be man, unable to communicate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy university

Burdur, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 33177864BACKGROUND
  • 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. No abstract available.

MeSH Terms

Conditions

Chronic DiseaseCOVID-19

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 9, 2021

Study Start

August 15, 2020

Primary Completion

January 25, 2021

Study Completion

June 10, 2021

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations