NCT07646756

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

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

September 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

May 22, 2026

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong University

Jinan, Shandong, 250000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 15, 2026

Study Start

September 1, 2022

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations