- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03074383
Improvement of Care for Outpatients With Type 2 Diabetes Through Self-Care Multidisciplinary Workshop for Diabetes
Improvement of Care for Outpatients With Type 2 Diabetes at the Porto Alegre Clinic Hospital Through Self-Care Multidisciplinary Workshop for Diabetes: a Randomized Controlled Trial
연구 개요
상세 설명
Ninety-six patients with type 2 diabetes from our Diabetes Outpatient Clinic will be randomly assigned to maintain standard treatment or participate in the Self-Care Multidisciplinary Workshop for Diabetes. The workshop consists of 15-minute individual meetings with each professional of a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care. The workshop will be offered in 3 different modules with 2 to 4 weeks difference between them.
Patients will be followed for 12 months. The variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, 브라질, 90035-903
- Hospital de Clínicas de Porto Alegre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7.5% and age greater than 18 years
Exclusion Criteria:
- Types of diabetes other than type 2 diabetes; neurological, psychiatric or cognitive impairment that prevents proper understanding and participation in the workshop
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Workshop
Self-Care Multidisciplinary Workshop for Diabetes consist in individual meetings with a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) in which education and self-care topics will be approached.
The workshop will be offered in 3 different modules with 2-4 weeks difference between them.
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A 15-minute Individual meetings with each professional (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) of the multidisciplinary team in which diabetes education and self-care topics will be approached.
다른 이름들:
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활성 비교기: Usual Care
Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.
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Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycated hemoglobin from baseline at 12 months
기간: 12 months
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Variation of glycated hemoglobin
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycated hemoglobin from baseline at 6 months
기간: 6 months
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Variation of glycated hemoglobin
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6 months
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Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months
기간: 6 months
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Diabetes Quality of Life Questionnaire
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6 months
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Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months
기간: 12 months
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Diabetes Quality of Life Questionnaire
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12 months
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Glycated hemoglobin equal or less than 8,0
기간: 12 months
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Number of patients reaching glycated hemoglobin equal or less than 8,0
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12 months
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Glycated hemoglobin equal or less than 7,5
기간: 12 months
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Number of patients reaching glycated hemoglobin equal or less than 7,5
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12 months
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Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months
기간: 6 months
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Change in SDSCA score 6 months after baseline
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6 months
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Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months
기간: 12 months
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Change in SDSCA score 12 months after baseline
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12 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Beatriz DAgord Schaan, PhD, Hospital de Clínicas de Porto Alegre
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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