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Clinical Trials/NCT06020105
NCT06020105
Not yet recruiting
Not Applicable

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

University of Évora0 sites80 target enrollmentJanuary 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
University of Évora
Enrollment
80
Primary Endpoint
cholesterol in mg/dl
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2024
End Date
July 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Évora
Responsible Party
Principal Investigator
Principal Investigator

Cláudia Mendes

Principal Investigator

University of Évora

Eligibility Criteria

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

Outcomes

Primary Outcomes

cholesterol in mg/dl

Time Frame: 1 year

Blood sample

Body image

Time Frame: 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

Time Frame: 1 year

scale

Anxiety and depression

Time Frame: 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

Time Frame: 1 year

stadiometer

Physical Function

Time Frame: 1 year

Six-Minute Walk Test (6MWT)

Food-related aspects

Time Frame: 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

Time Frame: 1 year

Barriers and facilitators of physical activity Questionnaire on open questions

Glucose in mg/dl

Time Frame: 1 year

Blood sample

Mean blood pressure

Time Frame: 1 year

Blood sample

Self-Esteem

Time Frame: 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 Outcomes

  • physical activity level(1 year)
  • Health-related Quality of life (IWQOL)(1 year)
  • Satisfaction with follow-up by nurses(1 year)

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