Smoking Cessation in Hospitalized Patients Using an App

NCT04502004 | Unknown DMC

• 1 other identifier: IB 3835/19 PI
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This study generates a new proposal for intensive intervention following the recommendations to quit smoking in hospitalized patients, providing intensive, accessible and individualized treatment, as well as long-term follow-up, thanks to new technologies. The main advantage that mhealth can bring to public health is cost-effectiveness, scalability and wide reach compared to traditional treatments. Rapid diffusion and remote outreach can impact traditional treatment programs, reduce waiting lists for tobacco visits, and increase quit rates, as well as reduce barriers to accessing smoking cessation programs, by location or time conflicts. Since the possibility of continuous face-to-face support is very limited, health interventions carried out through a smartphone can help avoid this situation. The study by Finkelstein and Me Cha (2016) justifies this line of intervention and solves the doubt about the feasibility of using the mobile phone to quit smoking in hospitalized patients, highlighting its usefulness for all patients regadless their age, gender, computer skills, income and educational level.

• Can an App apply an intensive intervention to stop smoking in the hospitalized patient?

Conditions

Hospitalized Smokers; CBT; Smoking Cessation; Mhealth

Outcome Measures

Primary Outcomes (1)

• effectiveness of the App intervention

  32 participants will have a objective measure of tobacco abstinence from the carbon monoxide level, abstinent if CO≤6 at 6 and 12 months of follow-up

  1 year

Study Arms (2)

Control Group (CG)

NO INTERVENTION

Receive the recommendations of the Clinical Practice Guidelines which consist of: advice on smoking cessation smoking, leaflet with information (tobacco components, treatments to reduce withdrawal syndrome). Follow-up after discharge by the hospital tabacco service: at one month, at three months, at six months and at one year.

Experimental Group (EG)

EXPERIMENTAL

Receive codes to download the App "NoFumo+" . Is a mHealth that offer a CBT program. Follow-up after discharge by the hospital tabacco service: at one month, at three months, at six months and at one year.

Device: App for health=mhealth

Interventions

App for health=mhealth DEVICE

Cognitive-Behavioural Therapy and Clinical Practice Guide that recommends 5 Aes: Ask about tobacco, Advise smoking cessation, Assess tobacco consumption, Assist and Arrange (Fiore et alt., 2008)

Also known as: (NoFumo+)

Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of both sexes, who sign the informed consent to participate in the study.
• Patients who register wanting to quit smoking during admission
• Active smoking patients at the time of hospital admission or ex-smokers with less than 6 months of evolution.
• Autonomous patients with the capacity to understand the treatment.
• Patients who have an Android and Iphone Smartphone, accustomed to their use sith superior operating system 5.0 or 4.0 respectively.

You may not qualify if:

• Serious medical illness that prevents the patient from participating in the tobacco cessation intervention study.
• Ex-smoking patients of more than 6 months of evolution.
• Active patients in substance abuse.
• Patients with any current condition (medical, psychological or social) that limits the patient's participation in the study.

Sponsors & Collaborators

• University of the Balearic Islands: lead
• Hospital Son Llatzer: collaborator

Study Sites (1)

Universidad de las Islas Baleares

Palma de Mallorca, Balearic Islands, 07122, Spain

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To assess differences between groups, use the student t-test or the Mann-Whitney U-test for quantitative variables; and the chi-square test or Fisher's exact test for qualitative variables. Correlations are examined by the Spearman or Pearson rank correlation. Paired or related sample tests will be used to assess intra-group differences. A value of p \<0.05 will be considered an indicator of a significant difference.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: November 14, 2019
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)