Clinical trial NCT06742645: The Use of Brief Motivational Interviewing in Community Health Centers.
Official title: The Use of Brief Motivational Interviewing in Community Health Centers. Controlled Trial on Quality of Life and Perceived Health Status
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects
Keywords: Motivational Interviewing
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2024-12-19
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: INTERVENTION The health workers of the Borgo Reno Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. Subsequently, the citizen included in the study is subjected to the intervention, short motivational interview (BMI). By putting the relationship, listening, assertive communication, motivation and direct involvement of the patient in the treatment path in the foreground, the trained workers conduct the BMI to motivate the users of the various services to improve their lifestyles. Objectives to be achieved within six months will be agreed upon. The short motivational interview lasts approximately 15 minutes COMPARISON The health workers of the Navile Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire
Primary purpose: OTHER

Brief summary: The research project aims to detect the effect of the Brief Motivational Interview (BMI) on the motivation to change risky behaviors and the adoption of healthy lifestyles by citizens attending Community Health Centers (CdC). The controlled, multicenter, prospective design study involves the enrollment of 304 people, with 152 at the Borgo Reno CdC and 152 at the Navile CdC.

Detailed description: The study will include 152 citizens who use the services of the Borgo Reno Community Health Center and 152 citizens from the Navile Community Health Center. Eligible participants will be identified with the help of specialist medical staff and nursing staff at the facility. Once an eligible participant is identified, the Brief Motivational Interview (BMI) can be conducted during regular institutional activities (if the operator on duty at that time is trained to conduct the BMI and after obtaining informed consent and completing the SF-36 questionnaire) or by scheduling an appointment with the nursing and/or facility staff for a dedicated BMI clinic.

Students from the degree courses in "Psychology," "Human Nutrition, Wellness, and Health," and "Wellness, Sport, and Health," who are appropriately trained and authorized, will contribute to the research study by providing all necessary information. Participants in the experimental group who are given an appointment will sign the informed consent for participation and consent for the processing of personal and sensitive data. They will also receive a letter for their general practitioner explaining the study procedures. Inclusion and exclusion criteria will be assessed. If the criteria are met, the citizen will be included in the study.

Citizens enrolled at the Borgo Reno Community Health Center will be assigned to the experimental group (with intervention), while those enrolled at the Navile Community Health Center will be part of the control group (without intervention). A clinic will be dedicated to this study, where professionals (specialist/home nursing staff, dietitians, physiotherapists, IFeC) from the Community Health Center who have received training from the CCM course on Brief Motivational Interviewing will conduct the sessions.

Eligibility criteria: Inclusion Criteria:

* first visit to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services or other medical specialties of the Borgo-Reno or Navile Community Home or referred to them.
* resident in the AUSL of Bologna
* age ≥18 years

Exclusion Criteria:

* second or more visits to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services, or other medical specialties of the Borgo-Reno or Navile Community House or referred to them.
* first visit to a service not indicated in the inclusion criteria
* not resident in the territory of the AUSL of Bologna
* age \<18 years

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: From enrollment to the end of treatment at 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Dipartimento Sanità Pubblica
state: IT
Study officials:
References:
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