BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management
BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management Evaluation of a Post-operative Nutrition and Lifestyle Management for Lifelong Care of Post-bariatric Patients in Primary Care
연구 개요
상세 설명
During last decades the prevalence of obesity is growing. Therefore, the number of bariatric procedures are also increasing. Frequent complications after surgery are nutritional deficiencies (e.g. vitamins, minerals, protein) which require mandatory long-term follow-up. So far adequate follow-up programs are only provided in specialized bariatric centers like in the outpatient clinic for obesity at the General Hospital of Vienna. These programs are focusing on prevention and premature identification of deficiencies.
Rising numbers of bariatric-surgical procedures pose a challenge for bariatric centres because of the accumulating numbers of bariatric patients requesting follow-up at least once a year.
To provide full coverage an appropriate possibility would be to transfer follow up to non-specialised facilities including general practitioners and family doctors using a so called "pass" providing practical treatment recommendations (necessary follow-up appointments, laboratory blood tests, questions regarding nutrition and lifestyle behavior).
To our best knowledge such a structured post-bariatric care management program in primary care does not exist by now. The aim of this study is therefore the evaluation of such a pass.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Please Select
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Vienna, Please Select, 오스트리아, 1090
- 모병
- Medical University of Vienna
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연락하다:
- Tamara Ranzenberger-Haider, MSc
- 전화번호: 00436765202648
- 이메일: tamara.ranzenberger-haider@muv.ac.at
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- older than 18 years and each sex,
- bariatric-surgical treatment - in particular omega loop gastric bypass, Roux-en-Y-gastric bypass - and sleeve gastrectomy at the department of surgery General Hospital Vienna,
- Operation date maximum 21 months before study beginning,
Exclusion criteria:
- Pregnancy (a possible existing pregnancy is excluded by questioning)
- Nursing mothers
- Not German speaking patients
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: Intervention: Usability Questionnaire
Patients hand over the usability questionnaire to evaluate the self developed structured follow-up program in form of a so-called pass to their family doctor twice in six months.
Family doctors examine the postbariatric patient using the pass and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.
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Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits.
Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients.
Family doctors fill out the questionnaire and returns it to the investigator.
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다른: Control: Usability Questionnaire
Patients hand over the usability questionnaire to evaluate the state of the art guideline for postbariatric follow up appointments in form of a folder "Metabolische Chirurgie und die perioperative Betreuung" to their family doctor twice in six months.
Family doctors examine the postbariatric patient using the guideline and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.
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Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits.
Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients.
Family doctors fill out the questionnaire and returns it to the investigator.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Usability questionnaire
기간: 6 months
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Usability of the follow-up passes (intervention and control) will be evaluated in primary care. In a pilot study the usability questionnaire was evaluated. The patient hands over the follow-up pass together with the questionnaire at each appointment (twice) at the family doctor. A stamped envelope to return the questionnaire is included. Family doctors will be asked to complete a series of actions regarding the content of the follow-up passes. Each action will be rated in a 5 point likert scale. An average score will be calculated for each question. |
6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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change in fat free mass
기간: 6 months
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A Bioelectric impedance analysis will be used to calculate change in fat free mass.
Measurements will be conducted by a device sending weak electric signals through the patients body.
The method is non-invasive.
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6 months
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change in body weight
기간: 6 months
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Patients will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using a digital scale.
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6 months
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Measures of adherence after 6 months
기간: 6 months
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Number of patients returning to the outpatient clinic after the intervention.
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6 months
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Calcium Blood Value
기간: 6 months
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Change in Calcium levels (mg/dL) after 6 months
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6 months
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Iron Blood Value
기간: 6 months
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Change in Ferritin levels (ng/mL) after 6 months
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6 months
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Vitamin B12 Blood Value
기간: 6 months
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Change in B12 levels (pmol/L) after 6 months
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6 months
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Vitamin D Blood Value
기간: 6 months
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Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months
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6 months
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Folic Acid Blood Value
기간: 6 months
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Change in Folic Acid levels (nmol/L) after 6 months
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6 months
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HbA1c Blood Value
기간: 6 months
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Change in Hemoglobin A1c (%) after 6 months
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6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- 2079/2017
약물 및 장치 정보, 연구 문서
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