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The NURLIFE Program for the Management of Bariatric Surgery Patients

Sponsor
University of Évora (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06020105
Collaborator
(none)
80
Enrollment
2
Arms
18.9
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NURLIFE
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Design and Development of a Nurse-led Program for the Management of Bariatric Surgery Patients - The NURLIFE Program
Anticipated Study Start Date :
Jan 2, 2024
Anticipated Primary Completion Date :
Jan 2, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Body weight [1 year]

    scale

  2. Height [1 year]

    stadiometer

  3. cholesterol in mg/dl [1 year]

    Blood sample

  4. Glucose in mg/dl [1 year]

    Blood sample

  5. Mean blood pressure [1 year]

    Blood sample

  6. Physical Function [1 year]

    Six-Minute Walk Test (6MWT)

  7. Food-related aspects [1 year]

    Eating Questionnaire

  8. Anxiety and depression [1 year]

    Social appearance anxiety scale (SAAS)

  9. Body image [1 year]

    Body Image Perception Questionnaire

  10. Self-Esteem [1 year]

    Coopersmith Self-Esteem Scale (CSES)

  11. Barriers and facilitators of physical activity [1 year]

    Barriers and facilitators of physical activity Questionnaire

Secondary Outcome Measures

  1. Health-related Quality of life [1 year]

    Quality of life will be assessed using the general health and well-being questionnaire

  2. physical activity level [1 year]

    Activity Log App

  3. Satisfaction with follow-up by nurses [1 year]

    Assessment Form of Nurse-led Educational Activities Satisfaction questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Évora

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cláudia Amaro dos Santos, Cláudia Mendes, University of Évora
ClinicalTrials.gov Identifier:
NCT06020105
Other Study ID Numbers:
  • 1635/22
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cláudia Amaro dos Santos, Cláudia Mendes, University of Évora
Case manager
e-health
Nurse case management
Bariatric surgery
Perioperative care

Study Results

No Results Posted as of Aug 31, 2023