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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Please Select
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Vienna, Please Select, Rakousko, 1090
- Nábor
- Medical University of Vienna
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Kontakt:
- Tamara Ranzenberger-Haider, MSc
- Telefonní číslo: 00436765202648
- E-mail: tamara.ranzenberger-haider@muv.ac.at
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Usability questionnaire
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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change in fat free mass
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 6 months
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Change in Hemoglobin A1c (%) after 6 months
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6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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