- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07646756
Longitudinal Evaluation of Preoperative eHealth Literacy and Nutritional Index on Early Functional Recovery After Fragility Fractures
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Shandong
-
Jinan, Shandong, 중국, 250000
- Shandong University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Barthel Index
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2022-R-184
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .