- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03951168
Health Education for Diabetes Mellitus (hefdm)
Study on Standardized Management Model of Health Education for Diabetes Mellitus
연구 개요
상세 설명
The aim was to develop a standardized patient education model reflecting the core educational elements recommended by Chinese diabetes society guideline, which could be delivered by nurses to hospitalized diabetes patients, and which could be easily scaled-up and implemented in China tier 3 hospital setting.
Management mode of standardized diabetes mellitus health education in intervention group.The control group carries on the routine diabetes mellitus health education management. In intervention group , All participants received Management mode of standardized diabetes mellitus health education.The standardized patient education included one-week personalized education on diabetes knowledge, diet and excise, glucose monitoring and hypoglycemia self-management and others during the hospitalization period. After discharge, patients were followed through the phone call at 2and 4 weeks. Follow-up of diabetic education outpatients at 12 and 24 weeks after discharge. The education nurse gave recommendations according to patent's problem during the follow-up. Full-time education nurses carry on education according to diabetes mellitus health education path table. In routine, After hospitalization, the responsible nurses interspersed with diabetes health education during the hospitalization. The health education is mainly about the problems observed by the responsible nurses and the problems raised by the patients. The patients were followed up by telephone 2 weeks after discharge.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710061
- First Affiliated Hospital of Xi'an Jiaotong University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Type 2 diabetes patients with World Health Organization(WHO) diagnosis (1999);
- HbA1c ≥ 7.5%;
- history of diabetes < 2 years;
- age from 18 to 70 years;
- having the ability of autonomous behavior, informed consent and voluntary participation in the study.
Exclusion Criteria:
- type 1 diabetes mellitus, gestational diabetes mellitus and other special types of diabetes;
- severe acute and chronic diseases, severe psychological failure, lung failure, tumor, etc.
- is participating in other researchers.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: Routine Management
The patients were divided into routine diabetic health education management model group.
Patients who meet the criteria for admission and discharge.
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Routine Management Model of Health Education for diabetes Patient will receive the Routine Management Model of Health Education for Diabetes.
After the patient was admitted to hospital, the responsible nurse carried on the diabetes health education for the patient.
There are no regulations on the path and time of education.
Interspersed with diabetes health education at work.
Follow up 2 weeks with phone call after discharge.
This is the current clinical model in hospital.
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실험적: Standardized Management
The patients were divided into standardized diabetes health education management model group.
Patients who meet the criteria for admission and discharge.
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Standardized Management Model of Health Education for Diabetes The patients were educated by full-time diabetic education nurses according to diabetes education path.
Including diabetes diet, exercise, drugs, hypoglycemia, diabetic foot, and so on.
Telephone follow-up was performed at 2 weeks and 4 weeks after discharge and 12 and 24 weeks follow-up in diabetes education clinic.
Develop telephone follow-up standardized content and implement telephone follow-up according to standardized content.Full-time education nurses carry on education according to diabetes mellitus health education path table.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Diabetes knowledge questionnaire ( DKQ)
기간: after 6 months
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The DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy, clarity and content equivalence by conducting forward and back translations to verify translation equivalence. DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy,clarity and content equivalence by conducting forward and back translations to verify translation equivalence. |
after 6 months
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Summary of Diabetes Self-Care Activities-6 (SDSCA-6)
기간: after 6 months
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Evaluation the patient self management skill
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after 6 months
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Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)
기간: after 6 months
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Evaluation the patient empowerment
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after 6 months
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Diabetes Specific Quality of Life
기간: after 6 months
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Evaluation the patient quality of life
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after 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
HbA1c
기간: after 6 months
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the patient'S blood glucose level
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after 6 months
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Fasting glucose
기간: after 6 months
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the patient'S blood glucose level
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after 6 months
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2h postprandial glucose
기간: after 6 months
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the patient'S blood glucose level
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after 6 months
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blood pressure
기간: after 6 months
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the patient 'S blood pressure
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after 6 months
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Total Cholesterol
기간: after 6 months
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the patient'S Total Cholesterol
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after 6 months
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LDL-C
기간: after 6 months
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he patient'S LDL-C
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after 6 months
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HDL-C
기간: after 6 months
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he patient'S HDL-C
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after 6 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Meng Li, First Affiliated Hospital of Xi'an JiaoTong Univerisity
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 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. .
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