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Recruiting NCT06742645

The Use of Brief Motivational Interviewing in Community Health Centers.

No phase Interventional Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Motivational Interviewing, Standard of Care (SOC).
Who it may be relevant to
Registry conditions: Healthy Subjects. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Use of Brief Motivational Interviewing in Community Health Centers. Controlled Trial on Quality of Life and Perceived Health Status

Overview

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.

Interventions

  • Behavioral Brief Motivational Interviewing
    Brief Motivational Interviewing (BMI), the object of the training and of the present research study, is an interview methodology that includes the intervention on the motivation to change of subjects with risky behaviors for their health, in order to obtain changes in their lifestyle and maintain correct behaviors for health over time (1). The BMI is mainly based on the Transtheoretical Model of Change by Di Clemente CC. and Prochaska JO (2). In particular, the BMI has been defined by its creat
  • Behavioral Standard of Care (SOC)
    Standard of Care (SOC) - The health workers of the Navile Community House carry out 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 outcome measures

  • Primary Outcome Measure [Time frame: From enrollment to the end of treatment at 6 MONTHS]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • Dipartimento Sanità Pubblica — Bologna

Publications

  • Ghizzardi G, Arrigoni C, Dellafiore F, Vellone E, Caruso R. Efficacy of motivational interviewing on enhancing self-care behaviors among patients with chronic heart failure: a systematic review and meta-analysis of randomized controlled trials. Heart Fail Rev. 2022 Jul;27(4):1029-1041. doi: 10.1007/s10741-021-10110-z. Epub 2021 Apr 17. PMID 33866487
  • Pedamallu H, Ehrhardt MJ, Maki J, Carcone AI, Hudson MM, Waters EA. Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review. J Med Internet Res. 2022 Aug 9;24(8):e35283. doi: 10.2196/35283. PMID 35943775
  • Rogers CR. A theory of therapy, personality and interpersonal relationships as developed in the client-centered framework. In: Koch S. (ed). Psychology: a study of a science, vol. III. Formulations of the person in the social context. McGraw Hill, New York, 1959.
  • Bandura A., Self-efficacy mechanism in human agency. American Psychologist, 1982; 37: 122-47
  • Miller WR, Rollnick S. Motivational Interviewing. Helping people change. Guilford Press, New York, 1991.
  • Prochaska JO. Di Clemente CC. Transtheorical therapy: toward a more integrative model of change. Psychotherapy, theory, research and practice 1982.
  • Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004 May;53(2):147-55. doi: 10.1016/S0738-3991(03)00141-1. PMID 15140454

Identifiers

NCT: NCT06742645 · 24014 - 81-2024-SPER-AUSLBO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗