- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07646756
Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Shandong
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Jinan, Shandong, China, 250000
- Shandong University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Barthel Index
Zeitfenster: 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.
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EQ-5D-5L
Zeitfenster: At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-5D-5L.
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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
Zeitfenster: 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
Zeitfenster: 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).
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At baseline, 3 days postoperatively, 7 days postoperatively and 30 days postoperatively data on EQ-VAS.
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 2022-R-184
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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