The NURLIFE Program for the Management of Bariatric Surgery Patients
- Conditions
- Bariatric Surgery CandidateNurse-Patient Relations
- Interventions
- Behavioral: NURLIFE
- Registration Number
- NCT06020105
- Lead Sponsor
- University of Évora
- Brief Summary
to analyze the influence of the new intervention in the perioperative period and impact on several clinical and humanistic endpoints. In the evaluation phase, an experimental, controlled, and randomized study (RCT) will be developed, with an intervention group (IG) and a control group (CG). The CG will receive the usual care and the IG, will receive the intervention for an expected period of one year. This project aims to be the first study to investigate the effect of a long-term specialized case-management intervention (face-to-face and e-health) in patients who are candidates for bariatric surgery during all the perioperative periods
- Detailed Description
The "nurse-led case-management" intervention program will allow to improve the management of the bariatric surgery process by patients in collaboration with the health team, with a view to improving health and adopting healthy lifestyles, which enhance better results. This intervention program is expected to be a mixed program with e-health technologies. Behavioural changes will be predictably one of the main objectives, with perception of the barriers and facilitators of them, from the perspective of training the patient for the physiological changes that result from the entire process of bariatric surgery. Thus, it is expected that the primary focus of the program will be health education and motivation for lifestyle changes, the promotion of healthy lifestyles and promotion of physical activity, with a view to improving anthropometric data and metabolic risk factors, as well as smoking cessation and alcoholic habits. As such, the contribution of a multidisciplinary team that is managed by a case-manager appears to be the most efficient intervention, and this activity aims to determine the set of procedures and their temporal sequence, the skills of the team, the flow of patients through the different elements of the team and the duration of the program.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
- Agree to participate in the study
- Surgical complications
- Psychiatric diseases and neurological disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group NURLIFE The intervention will be a combination of consultations and face-to-face follow-ups, with teleconsultations, based on other observational and experimental studies. The intervention program includes monitoring for one year of patients enrolled in the bariatric surgery consultation, with criteria for surgeries.
- Primary Outcome Measures
Name Time Method cholesterol in mg/dl 1 year Blood sample
Body image 1 year Body Image Perception Questionnaire (BIQ); the 19-item Body-Image Questionnaire; The total scores range from 0 to 72 with a higher score reflecting greater impairment and likelihood
Body weight 1 year scale
Anxiety and depression 1 year Social appearance anxiety scale (SAAS) is a16-item self-report measure; The items on the SAAS are rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely). The SAAS yields a total score, which can range from 16 to 80. Higher scores on the SAAS indicate greater social appearance anxiety.
Height 1 year stadiometer
Physical Function 1 year Six-Minute Walk Test (6MWT)
Food-related aspects 1 year Eating Questionnaire (EDE-Q) with 28 questions; the minimum values are 0,04 and maximum values are 4,97; Higher scores indicate greater levels of symptomatology
Barriers and facilitators of physical activity 1 year Barriers and facilitators of physical activity Questionnaire on open questions
Glucose in mg/dl 1 year Blood sample
Mean blood pressure 1 year Blood sample
Self-Esteem 1 year Coopersmith Self-Esteem Scale (CSES) The CSEI consists of 50 items and yields an overall score and four separate scores representing specific aspects of self-esteem, namely, general self, social self-peers, home parents, and school academic (or professional for adult form).
- Secondary Outcome Measures
Name Time Method physical activity level 1 year Activity Log App
Health-related Quality of life (IWQOL) 1 year Quality of life will be assessed using the general health and well-being questionnaire; The Impact of Weight on Quality of Life-Lite (IWQOL-Lite)© is a validated, 31-item; Scores range from 0 to 100, with 100 representing the best quality of life
Satisfaction with follow-up by nurses 1 year Assessment Form of Nurse-led Educational Activities Satisfaction questionnaire