The NURLIFE Program for the Management of Bariatric Surgery Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Design and Development of a Nurse-led Program for the Management of Bariatric Surgery Patients - The NURLIFE Program

Conditions
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Bariatric Surgery Candidate, Nurse-Patient Relations

Intervention / Treatment
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* Behavioral: NURLIFE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital Agree to participate in the study Exclusion Criteria: Surgical complications Psychiatric diseases and neurological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Behavioral: NURLIFE<br>* After the first consultation with the surgeon, the patients will be referred to the case manager, who will carry out the first face-to-face consultation, with consequent monitoring and clarification of identified needs, following the flowchart in figure 3, being referred to the different specialties, psychology, nutrition and nursing, fostering the case manager as the central pillar of the process, which will monitor each process individually, namely the number of consultations and necessary referrals.<br>|
| No Intervention: Control Group<br>The control group will only carry out the assessments and will be offered the same intervention as the intervention group at the end of the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | scale | 1 year | 
| Height | stadiometer | 1 year | 
| cholesterol in mg/dl | Blood sample | 1 year | 
| Glucose in mg/dl | Blood sample | 1 year | 
| Mean blood pressure | Blood sample | 1 year | 
| Physical Function | Six-Minute Walk Test (6MWT) | 1 year | 
| Food-related aspects | 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 | 1 year | 
| Anxiety and depression | 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. | 1 year | 
| Body image | 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 | 1 year | 
| Self-Esteem | 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). | 1 year | 
| Barriers and facilitators of physical activity | Barriers and facilitators of physical activity Questionnaire on open questions | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of life (IWQOL) | 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 | 1 year | 
| physical activity level | Activity Log App | 1 year | 
| Satisfaction with follow-up by nurses | Assessment Form of Nurse-led Educational Activities Satisfaction questionnaire | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Case manager, e-health, Nurse case management, Bariatric surgery, Perioperative care