Effectiveness of Primary Care Nurse-supervised Educational Group Interventions for Giving up Smoking

NCT07021417 | Completed

• 2 other identifiers: 06052025FFIS17/CE/01/26
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Background: To analyze the effectiveness of two group interventions for smoking cessa-tion (with support from the app) conducted by primary care nurses. Methods: A multi-center randomized controlled clinical trial occurred across eight Health Centres in the Murcia Region from 2018 to 2019. It involved daily smokers aged 18 and older who wanted to quit, had internet access, and spoke Spanish. Pregnant women, polydrug users, and individuals with psychiatric disorders were excluded from participation. Participants were randomly divided into two groups: one attending a single 4-hour Workshop, and the other attending a Course consisting of four 2-hour sessions. The analysis of smoking abstinence was performed using SPSS V22, with intragroup differences assessed through the chi-square test.

Conditions

Smoking Cessation

Keywords

Nurses; Nursing Evaluation Research; Primary Health Care; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who are abstinent (self-reported abstinence corroborated by an exhaled carbon-monoxide reading, expressed in parts per million).

  Assessment of effectiveness: Abstinence rates for the Course and the Workshop groups will be compared by means of the χ² test at 3-, 6-, 9- and 12-month follow-ups. Data will be analysed with SPSS v22; statistical significance will be set at p \< 0.05.

  Up to 12 months post-intervention (telephone contacts at months 3 and 9; face-to-face visits with carbon-monoxide testing at months 6 and 12).

Study Arms (2)

Workshop

EXPERIMENTAL

Format: A single group session of four hours' duration. Structure: All content and activities were concentrated into a single meeting. Methodology: Cognitive-behavioural techniques and participatory dynamics were employed, fostering motivation and vicarious learning among group members. Focus: The initial parts of the session were oriented towards preparing participants for smoking cessation, whilst the final segment focused on maintaining abstinence and preventing relapse. Materials: A standardised presentation and a procedural guide were utilised to ensure the homogeneity of the intervention. Digital Support: All participants received instructions on how to use the S'Acabó mobile application as a complement to the workshop.

Behavioral: Workshop

Course

EXPERIMENTAL

Format: A group programme comprising four weekly sessions of two hours each (eight hours in total). Structure: Sessions were distributed over the course of one month, allowing for a more gradual and sustained accompaniment. Methodology: Cognitive-behavioural techniques and participatory strategies were applied, facilitating the exchange of experiences and mutual support among participants. Focus: The first two sessions focused on preparation for smoking cessation, while the third and fourth sessions were dedicated to maintaining abstinence and preventing relapse. Materials: The same standardised materials and procedural guides as those used in the single workshop were employed. Digital Support: Use of the S'Acabó mobile application was also recommended as reinforcement for the content addressed in the face-to-face sessions.

Behavioral: Course

Interventions

Workshop BEHAVIORAL

includes a single 4-hour session

Workshop

Course BEHAVIORAL

Includes four weekly sessions totaling 8 hours (2 hours each)

Course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily smokers aged over 18 years.
• Smoking history of at least one year.
• Intention to quit smoking within one month.
• Ability to communicate in Spanish.
• Ownership of a mobile device with internet access.

You may not qualify if:

• Consumption of other drugs (excluding cannabis).
• Participation in smoking cessation programmes within the past year.
• Diagnosis of an acute psychotic disorder.
• Adolescents.
• Pregnant women.

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Faculty of Nursing

Cartagena, Murcia, 30203, Spain

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Adelaida Lozano-Polo, Phd

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: June 15, 2025
• Study Start: May 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2021
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)