WhatsApp Embedded in Routine Service Delivery for Smoking Cessation: Effects on Success Rates in a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Quitting success rates at the end of the 1st, 3rd and 6th month
研究概览
简要总结
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.
详细描述
Trial design
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. Both groups received the standard outpatient care of the clinic including aproximately 45 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.
Sample size
An a priori power analysis was conducted with OpenEpi, Version 3 by selecting a two-sided test to compare 30% success in the control group at 1st month versus 60% success rate in the intervention group with an error margin of 5%, a power of 80% and an allocation ratio of 1:2 which yielded a minimum sample size of 36 in the intervention and 72 in the control groups. For possible loss to follow-up, the sample sizes were increased by 20% to 43 and 86, respectively.
Randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: WhatsApp embedded in smoking cessation service (Behavioral)
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.
结局指标
主要结局
Quitting success rates at the end of the 1st, 3rd and 6th month
时间窗: 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.
次要结局
- The total number of follow-ups(3 months)
- The continuity to drug,(3 months)
- Self reported difference in weight in kilograms since the first contact(3 months)
研究者
Seyfi Durmaz
PhD MD, research asistant
Ege University