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Trial record 24 of 2035 for:    Smoking Cessation

WhatsApp Embedded in Routine Service Delivery for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03714971
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Seyfi Durmaz, Ege University

Brief Summary:

Background: Recently, the use of communication technologies and social media applications has become increasingly widespread to strengthen efforts for smoking cessation. The purpose of this study is; to assess the effect on success rate of the WhatsApp application which is embedded in the smoking cessation policlinic service delivery.

Materials and Methods: A randomized controlled intervention study was conducted with 132 volunteers who were followed up at the EUTF Smoking Cessation Policlinic between March-July 2017. The intervention content based on transtheoretic model was prepared and 60 WhatsApp messages were delivered to participants for 3 months of follow up. For data collection, initial interview form and follow up form consisting sociodemographic characteristics, smoking status, medical condition and treatment, were used. The success rate at first and third months were assessed by the point-prevalence regarding the previous week. Intention-to-treat analysis was used. For secondary outcomes; number of follow-ups, change in weight and continuity of medication were evaluated.

Findings: Success rate in the first month was 65.9% for intervention group and 40.9% in the control group; for the third month it was 50.0% in the intervention group and 30.7% in the control group. Being in the intervention group increased the success rate by 3,50 (1,30-9,44) times in the first month and 2,50 (1,08-6,40) times in the third month. The intervention was the only parameter effective in the two follow-up periods; the difference in success rate caused by gender, marital status and work-related social class has been eliminated after adjustment for the intervention.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: WhatsApp embedded in smoking cessation service Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was designed as a RCT including two parallel arms: an intervention group receiving messages through WhatsApp Messenger operating on smart phones and a control group not receiving these messages, with an allocation ratio of 1:2. Both groups received the standard outpatient care of the clinic including a 45-60 minutes face-to-face individual counseling at first contact ending with the decision of treatment and quit date, and a support booklet on quitting and subsequent follow-ups by the same clinician at 1st, 2nd, 4th weeks and 3rd month after quit date, either face-to-face at the clinic or by telephone if the patient does not come to the clinic for follow-up. The study was carried out in the smoking cessation clinic of Ege University Medical School's Public Health Department.
Masking: Double (Participant, Care Provider)
Masking Description: The study was designed as a single-blind study. The physicians (except the first author) were blind to the allocation to intervention or control groups and they conducted their routine smoking cessation counseling work. As long as the patient did not comment on the messages, the physicians were blind throughout the follow ups as well. After the first routine counseling, participants were informed by the first author about the study, thus they were not blind to the intervention. The analysis of the study was conducted by the first author who was not blind to the intervention/ control status of the participants. The first author could not be blind as he was to send out the WhatssApp messages. However, contact numbers of the participants were labeled with numbers (I-01 to I-44) to secure anonymity and to prevent any bias.
Primary Purpose: Treatment
Official Title: WhatsApp Embedded in Routine Service Delivery for Smoking Cessation: Effects on Success Rates in a Randomized Controlled Study
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Receiving WhatsApp messages
Among patients applying to the smoking cessation outpatient clinic between March and October 2017, >18-year old volunteers who smoked at least one cigarette/day, using WhatsApp at least on four days of the week, accepting the 3-month follow-up were included In receiving WhatsApp messages group.
Behavioral: WhatsApp embedded in smoking cessation service
The routine service delivery was ongoing as the intervention was conducted. In addition to the routine procedures in service delivery described above, WhatsApp messages were sent according to the plan.

No Intervention: Not receiving WhatsApp messages
In "not receiving WhatsApp messages" group; Stratification and randomization were both used to randomly allocate participants to both arms of the study. The intervention and control groups were first stratified according to physician and then gender, and later allocated in a simple random manner. Randomization was conducted using a computer spreadsheet. Allocation according to gender was conducted regarding the 2:3 female to male ratio in the routine cessation services and stratification according to physician aimed to have a balanced distribution among the different physicians working in the same cessation unit. As the target number of participants was small, further stratification was not applied. Simple random sampling was then used to allocate participants to each group.



Primary Outcome Measures :
  1. Quitting success rates at the end of the 1st, 3rd and 6th month [ Time Frame: 6 months ]

    Quitting success rates at the end of the 1st, 3rd and 6th month of follow-up in the intervention and control groups. Quitting success rate at 1st month was calculated with point prevalence. History of cessation was based on self report and those who declared not smoked even a single puff on a cigarette at all in the past two weeks were considered as "successful" in the quitting attempt (19). The success rate at 3rd month was calculated with point prevalence. In this point, not smoking at all in total in the past ten weeks was considered "successful" in the quitting attempt. The success rate at 6th month was calculated with point prevalence. In this point, not smoking at all in total in the past 24 weeks was considered "successful" in the quitting attempt.

    A decrease in success rates at six months is expected in comparison with 3 months as the intervention lasts for 3 months.



Secondary Outcome Measures :
  1. The total number of follow-ups [ Time Frame: 3 months ]
    The total number of follow-ups in the 1st, 3rd month. Contacts were divided into two categories: face-to face contacts and telephone calls. The total number of routine follow-ups was classified as adequate when 3 or more in the 1st month and a total of 4 follow-ups was considered as adequate at 3rd month. At 1st month, at least one of these follow-ups was required to be face-to-face for adequacy.

  2. The continuity to drug, [ Time Frame: 3 months ]
    The continuity to drug/NRT therapy was categorized as using the prescribed drug for <1 month or ≥1 month.

  3. Self reported difference in weight in kilograms since the first contact [ Time Frame: 3 months ]
    Any increase in weight (kg) was categorized as; has weight gain, no weight gain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Among patients applying to the smoking cessation outpatient clinic between March and October 2017,
  • >18-year old volunteers who smoked at least one cigarette/day,
  • using WhatsApp at least on four days of the week,
  • accepting the 3-month follow-up were included in the study.

Exclusion Criteria:

  • Besides people who did not meet the inclusion criteria, other patients applying to the clinic but who were referred to another centre without receiving any treatment,
  • people who were not 'ready to quit' according to the TTM stages of change evaluation
  • who had already quit before applying to the clinic were excluded.
  • If two or more patients were living in the same house or had applied to the clinic together, only the first of these was included and the rest were excluded from the study, as they could show the arriving messages to their friend/ partner/ relative.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714971


Locations
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Turkey
Ege University Faculty of Nedicine Public Health Departmant
İzmir, Turkey, 35100
Sponsors and Collaborators
Ege University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seyfi Durmaz, PhD MD, research asistant, Ege University
ClinicalTrials.gov Identifier: NCT03714971     History of Changes
Other Study ID Numbers: 16-12.1/11
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seyfi Durmaz, Ege University:
Whatsapp
smoking cessation
cessation service