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临床试验/NCT06500936
NCT06500936已完成不适用

Evaluation of an mHealth Intervention Using an Automated Text Message (SMS) Invitation System to Increase Participation in Mammography Screening Among Women Aged 50-69 Years in the Province of Santa Fe, Argentina

Centro de Estudio de Estado y Sociedad1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2021年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
248
试验地点
1
主要终点
Effectiveness outcome

研究概览

简要总结

We carried out with a mixed-method study including a pragmatic randomized controlled trial to evaluate effectiveness of the intervention and quantitative and qualitative evaluation of the implementation from women and stakeholders' perspective. In this report, we present results of the pragmatic randomized control trial and implementation evaluation from women´s perspective guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, specifically developed to assess interventions beyond efficacy across multiple public health criteria. RE-AIM framework was integrated in all stages of the research process, including conceptualization (e.g., selecting implementation processes that would be evaluated), data collection and analysis. Following Proctor´s Taxonomy of Implementation Outcomes [34], we also measured acceptability and appropriateness, which are essential to understand the success (or failure) of the implementation of an intervention from users' perspective. This approach is the same as we used to evaluate implementation in our previous study (The ATICA study).

详细描述

Breast cancer is the most common cause of death from cancer in women worldwide. In the Latin America and Caribbean region, each year 210,000 new cases are diagnosed, and 58,000 women die due this cancer (1). Access to early detection and appropriate treatment is needed for reducing the burden of this disease. According to the World Health Organization guidelines (2), in countries with well-established health systems, organized screening program with one mammography every two years has been proven effective to reduce mortality in women aged 50-74. Argentina is one of the Latin American countries with highest incidence and mortality rates in the region with 22,000 new cases and 6,800 deaths annually.(1) Breast cancer screening is opportunistic and despite several efforts to promote mammography, screening coverage remains low, around 40% in women with public health insurance (3). Therefore, the development of innovative and low-cost strategies for increasing access to breast cancer screening are needed.

The aim of the study was to evaluate effectiveness and implementation of an mHealth intervention based on SMS messages (the ATICA strategy) to promote participation in breast cancer screening among women aged 50 to 69 in Santa Fe, Argentina.

We carried out with a mixed-method study including a pragmatic randomized controlled trial to evaluate effectiveness of an mHealth intervention and quantitative and qualitative evaluation of the implementation guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework (4), specifically developed to assess interventions beyond efficacy across multiple public health criteria. RE-AIM framework was integrated in all stages of the research process, including conceptualization (e.g., selecting implementation processes that would be evaluated), data collection and analysis. Following Proctor´s Taxonomy of Implementation Outcomes (5), we also measured acceptability and appropriateness, which are essential to understand the success (or failure) of the implementation of an intervention from users' perspective. This approach is the same as we used to evaluate implementation in our previous study (The ATICA study (6-8)

Setting The study was conducted in the city of Santa Fe, the capital city of the province of Santa Fe, Argentina. The province of Santa Fe is located in the central region of Argentina. It is the third most populated province in the country, with 3,556,000 inhabitants of which 30% are women aged 50 and over and among them around 20% had public health insurance (9). Around 90% of the households had a cell phone (10).

Sample size The recruitment was conducted across ten selected healthcare centers (five in the north and 5 in the south of Santa Fe region) over a span of six months. Through this strategy, a total of 248 eligible women were successfully recruited between December 4, 2021, and July 7, 2022.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Women were randomly allocated either to the intervention or to the control group (1:1 ratio) using a computer-generated random number list generated by the study statistician. Blinding allocation was guaranteed, because neither the recruiters nor the field coordination knew the group to which women would be assigned. The local field coordinator sent the list of recruited women to the study coordinator on a weekly basis.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • A woman was eligible if she was 50+years, had not performed a mammography in the last two years, had not a breast cancer diagnosis and was able to provide a mobile phone number

排除标准

  • Women under 50 years
  • Women who had performed a mammography in the last two years,
  • Women who had breast cancer diagnosis

结局指标

主要结局

Effectiveness outcome

时间窗: 105 days from recruitment.

Percentage of women with a mammography recorded in SITAM within105 days from recruitment.

Effectivenes outcome

时间窗: 45 days from recruitment.

Percentage of women with a mammography recorded in SITAM within 45 days from

次要结局

未报告次要终点

研究者

发起方
Centro de Estudio de Estado y Sociedad
申办方类型
Other
责任方
Sponsor

研究点 (1)

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