The NURLIFE Program for the Management of Bariatric Surgery Patients (NURLIFE)

October 7, 2023 updated by: Cláudia Mendes, University of Évora

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
No Intervention: Control Group
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Évora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2024

Primary Completion (Estimated)

January 2, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1635/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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