Development and Reliability and Validity Testing of a Health Literacy Assessment Scale for Nursing Assistants

NCT07853820 | Enrolling By Invitation DMC

• 1 other identifier: KY20262267-C-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to develop and evaluate a health literacy assessment scale for caregivers (nursing assistants) working in medical institutions, based on their job characteristics and caregiving needs. The main questions it aims to answer are: Can the newly developed scale validly and reliably measure health literacy among caregivers in healthcare settings? What is the current level of health literacy among caregivers, and which factors are associated with it? Caregivers working in medical institutions (aged 18-65, with at least 3 months of caregiving experience) will complete survey questionnaires about their health literacy, health behaviors, and job characteristics. A subset will repeat the survey 14 days later to assess test-retest reliability.

Conditions

Health Literacy

Keywords

Health Literacy; Nursing Assistants; Scale Development; Mixed Methods; Caregivers

Outcome Measures

Primary Outcomes (5)

• Structural validity of the Health Literacy Assessment Scale for Nursing Assistants

  The structural validity of the newly developed Health Literacy Assessment Scale for Nursing Assistants will be evaluated using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), based on factor loadings and model fit indices.

  At completion of data analysis (approximately 3 months after the end of the large-sample survey).

• Content validity of the Health Literacy Assessment Scale for Nursing Assistants

  The content validity of the newly developed Health Literacy Assessment Scale for Nursing Assistants will be evaluated using the Content Validity Index (CVI).

  At completion of data analysis (approximately 3 months after the end of the large-sample survey).

• Convergent validity of the Health Literacy Assessment Scale for Nursing Assistants

  The convergent validity of the newly developedHealth Literacy Assessment Scale for Nursing Assistants will be evaluated using Average Variance Extracted (AVE).

  At completion of data analysis (approximately 3 months after the end of the large-sample survey).

• Internal consistency reliability of the Health Literacy Assessment Scale for Nursing Assistants

  The internal consistency reliability of the newly developed Health Literacy Assessment Scale for Nursing Assistants will be evaluated using Cronbach's α coefficient, Composite Reliability (CR), and split-half reliability.

  At completion of data analysis (approximately 3 months after the end of the large-sample survey).

• Test-retest reliability of the Health Literacy Assessment Scale for Nursing Assistants

  The test-retest reliability of the newly developed Health Literacy Assessment Scale for Nursing Assistants will be evaluated using the Intraclass Correlation Coefficient (ICC) at a 14-day interval.

  14 days after the initial survey.

Interventions

Health Literacy Questionnaire for Nursing Assistants OTHER

A structured self-report questionnaire designed to assess health literacy among nursing assistants(caregivers ) working in medical institutions, based on their job characteristics and caregiving needs. The scale is developed through literature review, semi-structured interviews, and two rounds of Delphi expert consultation, and validated via a multicenter questionnaire survey. Psychometric evaluation includes item analysis, exploratory and confirmatory factor analysis, content validity index, average variance extracted, composite reliability, Cronbach's α, split-half reliability, and test-retest reliability (14-day interval).

Also known as: Caregiver Health Literacy Assessment Scale

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nursing assistants (Caregivers) aged 18-65 years who have been working in medical institutions (including tertiary general hospitals and related healthcare facilities) for at least 3 months, with basic communication skills and the ability to understand the questionnaire. Approximately 300-400 eligible caregivers will be recruited across multiple centers. Interns, temporary support staff, non-regular in-service caregivers, individuals with severe hearing, speech, or cognitive impairment, those with frequent leave or imminent departure, and those who refuse or are unable to complete the questionnaire are excluded.

You may qualify if:

• Aged 18 to 65 years.
• Working as a caregiver (nursing assistant) in a medical institution (including tertiary general hospitals and related healthcare facilities) for at least 3 months.
• Has basic communication skills and the ability to understand the questionnaire.
• No recent job changes, and able to cooperate with the survey and the 14-day retest.
• Informed of the study and willing to participate.

You may not qualify if:

• Interns, temporary support staff, or non-regular in-service caregivers.
• Severe hearing, speech, or cognitive impairment that prevents communication.
• Frequent leave in the past month or imminent departure from the position.
• Refusal or inability to complete the questionnaire.

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710032, China

Location

Related Publications (5)

• Mu, H., Lu, W., & Lyu, J. (2025). Analysis of the current status for residents' depression, anxiety symptoms, mental health literacy and influencing factors of mental health literacy. Journal of Shandong University (Health Sciences), 63(12), 105-111. https://doi.org/10.6040/j.issn.1671-7554.0.2025.0815

  RESULT

• Chen, Y., & Liu, T. (2025). Construction of an evaluation indicator system for service quality of nursing assistants in public hospitals. China Hospitals, 29(1), 60-64.

  RESULT

• Shahid R, Shoker M, Chu LM, Frehlick R, Ward H, Pahwa P. Impact of low health literacy on patients' health outcomes: a multicenter cohort study. BMC Health Serv Res. 2022 Sep 12;22(1):1148. doi: 10.1186/s12913-022-08527-9.

  PMID: 36096793 RESULT

• Nymark C, Falk AC, von Vogelsang AC, Goransson KE. Differences between Registered Nurses and nurse assistants around missed nursing care-An observational, comparative study. Scand J Caring Sci. 2023 Dec;37(4):1028-1037. doi: 10.1111/scs.13175. Epub 2023 Apr 28.

  PMID: 37114356 RESULT

• [1]Organisation mondiale de la Santé (2025). La situation du personnel infirmier dans le monde en 2025 : investir dans la formation, l'emploi, le leadership et la pratique infirmière. Organisation mondiale de la Santé. https://iris.who.int/handle/10665/384380.

  RESULT

MeSH Terms

Interventions

Nursing Assistants

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: October 2, 2026
• Study Start: June 22, 2026
• Primary Completion: September 25, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)