- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07646756
Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Shandong
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Jinan, Shandong, Kina, 250000
- Shandong University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Barthel Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2022-R-184
Legemiddel- og utstyrsinformasjon, studiedokumenter
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