NCT05659693

Brief Summary

During menopause, women may experience many conditions and symptoms due to fluctuation in hormone levels. These symptoms can affect a woman's social and personal functioning and quality of life. The symptoms and quality of life experienced by women during menopause are closely related to health literacy and digital literacy levels. Women in the menopausal period often turn to alternative and complementary practices to cope with the symptoms. They obtain this information from Web 2.0 technologies (Instagram, Facebook, etc.) and other sources on the internet, along with the innovations brought by the developing world. However, they do not have enough skills to question the reliability and accuracy of the information sources they obtain. In this context, digital literacy emerges as a new concept in today's digital transformation. Digital Literacy is the awareness, attitude and ability of individuals to use digital tools and possibilities appropriately to identify, access, manage, integrate, evaluate, analyze and synthesize digital resources, create new information, create media expressions and communicate with others. With the developing technology and widespread use of the internet, the impact of the information obtained from digital platforms on the current health literacy and quality of life of women is gaining importance. In the literature, it has been determined that the relationship between digital literacy, health literacy and quality of life has been examined in different samples such as the elderly and individuals with chronic diseases. However, no research has been found in the literature examining the effect of a planned digital literacy education specific to menopause on the health literacy and quality of life of postmenopausal women. The age group in which the research is planned is a group that can use Web 2.0 technologies (Instagram, Facebook, etc.) and other sources on the internet, but we think that they have limited information about accessing information sources and examining the accuracy of the information they have obtained. In this context, we believe that a planned digital literacy education specific to menopause will increase the health literacy and quality of life of postmenopausal women.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 15, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

November 30, 2022

Last Update Submit

March 10, 2024

Conditions

Keywords

Postmenopausal Symptomsdigital literacyQuality of LifeHealth Literacymenopause

Outcome Measures

Primary Outcomes (3)

  • digital literacy education increases the digital literacy level of women

    Digital Literacy Scale: The Digital Literacy Scale (DFLS) developed by Ng (2012) consists of 17 items. The scale items are answered by the participants in a 5-point Likert structure as "5: Strongly agree, 4: Agree, 3: Undecided, 2: Disagree, 1: Strongly disagree". The lowest score that can be obtained for the whole scale is 17 and the highest score is 85. While interpreting the mean score of the scale; Score ranges were used between 1.00-1.80 very low, 1.81-2.60 low, 2.61-3.40 medium, 3.41-4.20 high, 4.21-5.00 very high. Low scores from the overall Digital Literacy scale indicate low Digital Literacy level, while higher scores indicate high digital literacy.

    The change in the digital literacy scale score of the participants in 2 months was evaluated with the digital literacy scale. Participants were expected to have an increase in their scores during this time.

  • digital literacy education increases women's health literacy level

    Health Literacy Scale: It is the scale of the 47-item HealthLiteracySurvey in Europe (HLS-EU) form developed by Sorensen (2012) and later simplified by working together again by Toçi, Bruzari and Sorensen. The Health Literacy scale consists of 25 items and four sub-dimensions. The lowest score for the whole scale is 25 and the highest score is 125. The items in the scale are answered by the participants in a 5-point Likert structure as "5: I have no difficulty, 4: I have little difficulty, 3: I have a little difficulty, 2: I have a lot of difficulty, 1: I am unable to do / I have no ability / impossible". Low scores indicate that the Health Literacy status is insufficient, problematic and weak, while high scores indicate that it is sufficient and very good. As the score obtained from the scale increases, the health literacy level of the individual increases.

    The change in the health literacy scale score of the participants in 2 months was evaluated with the health literacy scale. Participants were expected to have an increase in their scores during this time.

  • digital literacy education improves women's menopause-specific quality of life

    The Menopause-Specific Quality of Life Questionnaire (MENQOL) was developed by Hilditch et al. in 1996 in order to evaluate the quality of life of menopausal women. The scale consists of 29 Likert type questions and 4 sub-domains: vasomotor (questions 1-3), psychosocial (questions 4-10), physical (questions 11-26) and sexual (questions 27-29). The score for each question ranges from 1 to 8. In the scoring, 1 point indicates that the situation did not occur, 2 points indicate that the situation did occur, but it was not disturbing, and a score between 3-8 indicates the severity of the situation. High scores on the scale indicate low quality of life.

    The change in the participants' menopausal symptoms and coping skills at 2 months was evaluated with The Menopause-Specific Quality of Life Questionnaire. Participants were expected to have an increase in their scores during this time.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Digital literacy education specific to menopause will be given to this group.

Behavioral: digital literacy education specific to menopause

Control Group

NO INTERVENTION

no intervention will be applied to this group.

Interventions

Education; It is planned as 5 sessions in the form of presentation, homework, scenario and sending reminder messages. The training is planned to last approximately 20 minutes with a power point presentation prepared by the trainer. The survey will be evaluated in the first session. Women will be told what digital literacy is, why it is important, how to verify information and resources, security of accounts, resources, money and devices, access to information, understanding and valuing information. A screening and access to information session will be held with a scenario prepared on menopausal symptoms, taking into account the variables of information and resource security, access to information, understanding and valuing information, with examples on the digital platform. The woman will be given a scenario homework on menopausal symptoms. Interim evaluation will be made in the fourth week of the training. The final evaluation will be made in the fifth session.

Experimental Group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 45 - 65 years old,
  • Being in the postmenopausal period
  • Using a smart phone, tablet and/or computer
  • Digital literacy level of 3.40 and below

You may not qualify if:

  • Having a diagnosed psychiatric disorder
  • Having a diagnosed cancer disease
  • Scale item total score is in the high range between 3.41-4.20 and very high between 4.21-5.00 (Ng, 2012).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul university -cerrahpaşa, faculty of nursing

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • selcan bakır

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Women who meet the inclusion criteria will be included in the sample using a simple random method. Before the research numbers were produced from random.org, envelopes of the same size and characteristics were created for each participant by a person other than the researcher (IU-C, Research Assistant B.Y) and numbers between 1 and 120 were written on them. Then, considering the data losses, numbers from 1 to 120 were generated from random.org. The researcher will use online "spinning games" (https://www.kodvizit.com/cekilis/cark) while dividing the participants into groups. Numbers from 1-120 will be written on the online wheel on the site. The researcher will first apply a digital literacy scale to the woman who accepts the research. The woman with a scale score of 3.40 and below will be asked to spin the wheel from the online "spinning games" site and the experimental - control group will be determined. Experimental Group: 50 people Control Group: 50 people
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Type of Study: This study is a randomized controlled trial. The pre-test-post-test will be carried out with a pattern.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 21, 2022

Study Start

November 15, 2022

Primary Completion

March 20, 2023

Study Completion

March 10, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

The information obtained from this study will be used for research purposes and personal information will be kept confidential; however, the data may be used for publication purposes. 2 years after the completion of the study, the data will be destroyed by the destruction machine belonging to the institution and will be kept locked in a closed cabinet during this period.

Locations