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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Please Select
-
Vienna, Please Select, Austria, 1090
- Reclutamento
- Medical University of Vienna
-
Contatto:
- Tamara Ranzenberger-Haider, MSc
- Numero di telefono: 00436765202648
- Email: tamara.ranzenberger-haider@muv.ac.at
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Altro: 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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Usability questionnaire
Lasso di tempo: 6 months
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
change in fat free mass
Lasso di tempo: 6 months
|
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.
|
6 months
|
|
change in body weight
Lasso di tempo: 6 months
|
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.
|
6 months
|
|
Measures of adherence after 6 months
Lasso di tempo: 6 months
|
Number of patients returning to the outpatient clinic after the intervention.
|
6 months
|
|
Calcium Blood Value
Lasso di tempo: 6 months
|
Change in Calcium levels (mg/dL) after 6 months
|
6 months
|
|
Iron Blood Value
Lasso di tempo: 6 months
|
Change in Ferritin levels (ng/mL) after 6 months
|
6 months
|
|
Vitamin B12 Blood Value
Lasso di tempo: 6 months
|
Change in B12 levels (pmol/L) after 6 months
|
6 months
|
|
Vitamin D Blood Value
Lasso di tempo: 6 months
|
Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months
|
6 months
|
|
Folic Acid Blood Value
Lasso di tempo: 6 months
|
Change in Folic Acid levels (nmol/L) after 6 months
|
6 months
|
|
HbA1c Blood Value
Lasso di tempo: 6 months
|
Change in Hemoglobin A1c (%) after 6 months
|
6 months
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2079/2017
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .