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Health LiteracyNCT07853820

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

An observational study of Health Literacy, run by The First Affiliated Hospital of Air Force Medical University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Health Literacy
What is being tested?
Health Literacy Questionnaire for Nursing Assistants
How many people
1,000 participants
Where
1 siteChina
Study dates
22 Jun 2026to 30 Dec 2026
How long will I take part?
14 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The First Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi, 710032

Other trials in China

About this study

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?

Read more

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.

Read the detailed description

This is a non-interventional, methodological, mixed-methods study designed to develop and psychometrically validate a health literacy assessment scale for caregivers (nursing assistants) working in medical institutions. The study is guided by the Timing Theory and integrates qualitative semi-structured interviews, two rounds of Delphi expert consultation, and a quantitative multicenter questionnaire survey.

Study Design and Theoretical Framework The study adopts a mixed-methods design. Based on the Timing Theory and the concept of health literacy, an initial item pool will be generated through literature review and semi-structured interviews with caregivers. The item pool will then be refined through two rounds of Delphi expert consultation. Subsequently, a pilot survey and a large-sample multicenter survey will be conducted to evaluate the psychometric properties (validity and reliability) of the scale.

Study Phases

  • Phase 1 - Item pool generation and first-round Delphi: Literature review, theoretical framework construction, and semi-structured interviews with 10-15 caregivers (each interview lasting 20-30 minutes) will be conducted to form the initial item pool, followed by the first round of Delphi expert consultation.
  • Phase 2 - Second-round Delphi and pilot survey: The second round of Delphi expert consultation will be completed, and a small-sample pilot survey will be conducted to optimize the scale, resulting in the formal version of the caregiver health literacy assessment scale.
  • Phase 3 - Large-sample multicenter survey: A multicenter large-sample questionnaire survey will be conducted at tertiary general hospitals and related healthcare institutions. Data collection, entry, and processing will be completed, and a subsample will undergo a retest survey 14 days after the initial survey to assess test-retest reliability.
  • Phase 4 - Psychometric evaluation: Item analysis, validity testing, and reliability testing will be performed using SPSS 27.0 and AMOS 28.0 to determine the final version of the scale.
  • Phase 5 - Manuscript preparation: Research findings will be summarized and manuscripts will be prepared for submission.

Sample Size According to scale development requirements, the item-to-sample ratio should be 1:5 to 1:10. Exploratory factor analysis (EFA) requires at least 150 participants, and confirmatory factor analysis (CFA) requires at least 200 participants. Considering a potential 10% invalid response rate, the target sample size is set at N ≥ 300. The study plans to enroll approximately 300-400 caregivers across multiple centers.

Quality Control and Data Management

  • Investigators, interviewers, and data managers will receive unified training to standardize procedures and scripts.
  • One-on-one guidance will be provided during questionnaire completion; completeness and logical consistency will be checked on-site, and missing items will be supplemented promptly.
  • Double data entry and logical verification will be performed; invalid questionnaires will be excluded according to predefined criteria (key items missing ≥10%, regular or monotonous answering patterns, excessively short completion time, logical contradictions, or incomplete data).
  • Expert qualifications will be strictly screened; unified Delphi consultation forms and standardized collection, organization, and feedback procedures will be used.
  • Data will be anonymized using questionnaire codes, encrypted for storage, and retained for at least 5 years. Only members of the research team will have access to the data.

Statistical Analysis Plan Data will be analyzed using SPSS 27.0 and AMOS 28.0. Continuous variables will be presented as mean ± standard deviation or median (interquartile range); categorical variables will be presented as frequencies and percentages.

  • Item analysis: critical ratio method, item-total correlation, and homogeneity test.
  • Validity: construct validity will be evaluated through EFA and CFA; content validity will be assessed using the content validity index (CVI); convergent validity will be evaluated using average variance extracted (AVE); discriminant validity will be assessed using composite reliability (CR).
  • Reliability: internal consistency will be evaluated using Cronbach's α coefficient; split-half reliability will be calculated; test-retest reliability will be assessed using the intraclass correlation coefficient (ICC).

All statistical tests will be two-tailed, with a significance level of α = 0.05 (P < 0.05 considered statistically significant).

Missing Data Questionnaires with key items missing ≥10% will be excluded. For included questionnaires, missing data will be documented and handled according to predefined rules; variables reported as missing, unavailable, or inconsistent will be recorded, and appropriate statistical handling (e.g., pairwise deletion or multiple imputation where justified) will be applied and reported transparently.

Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the First Affiliated Hospital of the Air Force Medical University (Xijing Hospital). The study is non-interventional, involving only questionnaires, interviews, and expert consultation; no drugs, invasive procedures, or biological samples are involved, and there is no anticipated risk of adverse events. Informed consent is exempted under the ethics approval, and participant privacy and data confidentiality will be protected throughout the study.

Conditions
Health Literacy
Being tested
Health Literacy Questionnaire for Nursing Assistants
Keywords
Health Literacy, Nursing Assistants, Scale Development, Mixed Methods, Caregivers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Literacy Questionnaire for Nursing AssistantsOther

    Also called Caregiver Health Literacy Assessment Scale

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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).

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

  4. 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.

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

  5. 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.

    Measured: 14 days after the initial survey.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start22 Jun 2026
  3. Primary completion25 Sep 2026
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
Target duration
14 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07853820
Sponsor's protocol ID
KY20262267-C-1
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: * The protocol states: "Data will be encrypted and stored for at least 5 years, used for subsequent research analysis, without disclosing personal information." * "Only the research team will have access to the data" (questionnaire-coded anonymization, encrypted storage). * Participants are caregivers, and the data includes sensitive personal information (name, age, education, work tenure, health behaviors, contact details). * The document does not mention any plan to share individual participant data (IPD) with external researchers.

Publications

  • 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

  • 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.

  • 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.

    PubMed 36096793
  • 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.

    PubMed 37114356
  • [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.

Questions about this trial

What is this clinical trial studying?

An observational study of Health Literacy, run by The First Affiliated Hospital of Air Force Medical University at 1 site in China.

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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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?

Structural validity of the Health Literacy Assessment Scale for Nursing Assistants (time frame: At completion of data analysis (approximately 3 months after the end of the large-sample survey).). The study lists 5 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 NCT07853820, which also lists 5 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 2 Oct 2026.

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