Fragility FractureNCT07646756
Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures
An observational study of Fragility Fracture, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fragility Fracture
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Jul 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fragility Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-VAS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2022
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragility FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xun Guan, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646756
- Sponsor's protocol ID
- 2022-R-184
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures
- ClinicalTrials.gov ID
- NCT07646756
- Acronym / sponsor ID
- 2022-R-184
- Conditions
- Fragility Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- People diagnosed with fragility fractures according to the clinical "Primary Osteoporosis Diagnosis and Treatment Guidelines (2022 Edition)"[17] and based on the clinical diagnosis；
- ④ People who have provided informed consent and voluntarily participate in this study；
- ⑤ People aged ≥18 years.
Key exclusion criteria (2 listed)
- Individuals with severe cognitive impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fragility Fracture, run by Shandong 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Barthel Index (time frame: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on Barthel Index.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.