Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures

June 12, 2026 updated by: Xun Guan, Shandong University
The integration of digital technologies into chronic disease rehabilitation has transformed people care, yet the specific impact of electronic health literacy on early functional outcomes in fragility fracture people remains underexplored. This study investigates the association between preoperative eHealth literacy and both preoperative and early postoperative functional outcomes in people with fragility fractures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • People diagnosed with fragility fractures according to the clinical "Primary Osteoporosis Diagnosis and Treatment Guidelines (2022 Edition)"[17] and based on the clinical diagnosis；

    • People who have undergone conventional surgical treatment；

      • People who are conscious and able to communicate normally； ④ People who have provided informed consent and voluntarily participate in this study； ⑤ People aged ≥18 years.

Description

Inclusion Criteria:

  • People diagnosed with fragility fractures according to the clinical "Primary Osteoporosis Diagnosis and Treatment Guidelines (2022 Edition)"[17] and based on the clinical diagnosis；

    • People who have undergone conventional surgical treatment； ③ People who are conscious and able to communicate normally；

      ④ People who have provided informed consent and voluntarily participate in this study；

      ⑤ People aged ≥18 years.

Exclusion Criteria:

  • Individuals with severe cognitive impairment;

    • Pathological fractures caused by tumors or other reasons; ③ People with other severe diseases, such as cancer, severe cardiopulmonary diseases, etc., who are unable to cooperate; ④ Individuals currently participating in other research projects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on Barthel Index.
Barthel Index (BI) is widely used to quantify activities of daily living and is sensitive to short-term changes during hospitalization. A low BI at discharge limits the effectiveness of rehabilitation and is associated with poor prognosis. The lowest score on this scale is 0, and the highest score is 100.
At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on Barthel Index.
EQ-5D-5L
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-5D-5L.
EQ-5D is a health-related quality of life (HRQoL) questionnaire widely used in economic, clinical, and population health studies. The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It has two versions, a three-level EQ-5D (EQ-5D-3L) and a five-level EQ-5D (EQ-5D-5L). Each dimension of the EQ-5D-3L consists of 3 levels: no difficulty at all, some difficulty, and extreme difficulty.
At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-5D-5L.
PNI
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on PNI.
The PNI was derived using the formula: 10 × serum albumin (g/dL) + 0.005 × lymphocyte count (/mm3). Serum albumin < 4.0 g/dL = 1 point, ≥4.0 g/dL = 0 points and LMR < 4.44 = 1 point, ≥4.44 = 0 points. The total PNI varied from 0 to 4, higher values reflect a more favorable nutritional and inflammatory profile.
At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on PNI.
EQ-VAS
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-VAS.
Participants rated their current health on a 100-point EQ visual analog scale (EQ VAS), ranging from "worst imaginable health state" (0) to "best imaginable health state" (100).
At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-VAS.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-R-184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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