- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646756
Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shandong
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Jinan, Shandong, China, 250000
- Shandong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Barthel Index
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on Barthel Index.
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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.
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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.
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At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-5D-5L.
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PNI
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on PNI.
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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.
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At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on PNI.
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EQ-VAS
Time Frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-VAS.
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-R-184
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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