跳至主要内容
临床试验/NCT05506436
NCT05506436已完成不适用

Evaluation of an Implementation Strategy of mHealth Intervention for the Promotion of Healthy Lifestyles in Primary Healthcare (E-VIDAPP Pilot Study)

Fundacion para la Investigacion y Formacion en Ciencias de la Salud1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Use of the intervention EVIDENT 3

研究概览

简要总结

The translation of beneficial interventions for the population into professional practice represents a constant challenge. Moreover, implementation of this evidence into clinical practice has been limited to date. Therefore, the aim of this pilot study is to identify the critical factors and barriers that may influence the implementation of a digital intervention for the promotion of exercise and a healthy diet in primary care and its implementation through a pilot study with a strategy agreed with nursing professionals in a health centre.

详细描述

DESIGN: Pilot study with mixed methodology (quantitative and qualitative). A pre-implementation visit was performed to evaluate the variables of the study. After completion of this visit, intervention and control groups are randomly assigned. Training and participatory sessions are carried out in the intervention group. After these sessions, the EVIDENT 3 intervention is implemented for 6 months in the nursing offices. After this 6-month period, the final evaluation will be carried out, as well as a focus group in the intervention group.

STUDY POPULATION: The study participants are the nursing professionals working in the health centers that have been working in one of the selected centers for at least 6 months prior to the start of the study, with permanence in the same until the end of the study, who agree to participate and who sign the informed consent form.

IMPLEMENTATION STRATEGY

  1. Specific intervention in the intervention group: 4 training sessions on the following topics: 1-Evident intervention, 2-Evidence-based clinical practice, 3- Main components of Normalization Process Theory, 4- Implementation strategies.
  2. Intervention to be implemented: The intervention to be explained to the professionals is the EVIDENT 3 intervention, which proves its efficacy previously. It consists of brief advice on nutrition, using the plate method (50), and advice on physical activity based on the current recommendations of at least 30 minutes of moderate activity 5 days a week, or 20 minutes of vigorous activity, 3 days a week. In addition, the EVIDENT 3 mobile app is included, which was designed to allow self-reporting of daily nutrition. Once the user enters all the information, the app integrates all the data to create personalized recommendations and weight loss goals.
  3. Qualitative research: In the final evaluation of the study, a focus group discussion will be conducted from a phenomenological perspective, only with participants from the intervention group. The sampling will be theoretical in order to achieve maximum discursive plurality. A random selection of the participants who have marked the option to participate in the qualitative study in the consent form will be contacted.

STRUCTURE OF THE STUDY VISITS:

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 (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Nurses who have been working in one of the selected centers for at least 6 months prior to the start of the study, with permanence until the end of the study.
  • •Acceptance to participate and sign the informed consent form

排除标准

  • •Nurses who have been working at the center for less than 6 months.

研究组 & 干预措施

Implementation group

Experimental

Four sessions are conducted with the nurses of the center assigned to the intervention group to agree on the implementation strategy together with the professionals. Once the strategy is defined, the implementation of the intervention will be launched in this group for 6 months. After this period, the final evaluation will be carried out, as well as a qualitative evaluation through a focus group.

干预措施: Implementation strategy (Other)

Implementation group

Experimental

Four sessions are conducted with the nurses of the center assigned to the intervention group to agree on the implementation strategy together with the professionals. Once the strategy is defined, the implementation of the intervention will be launched in this group for 6 months. After this period, the final evaluation will be carried out, as well as a qualitative evaluation through a focus group.

干预措施: Evident 3 (Device)

Control group

Active Comparator

A single session will be scheduled to introduce the nurses of the center assigned to this group to the EVIDENT 3 intervention, and access and downloading will be allowed for free use in their practice.

干预措施: Evident 3 (Device)

结局指标

主要结局

Use of the intervention EVIDENT 3

时间窗: 6 months

It will be evaluated by the number of downloads of the application from the platform created for this purpose in RedCap per primary health centre.

Number of obesity-related activities in primary health care

时间窗: 6 months

It will be evaluated with the clinical practice questionnaire in the management of obesity, which evaluates the frequency (weekly, monthly or never) of 7 activities that are performed in the office related to obesity. This questionnaire has no cut-off point.

次要结局

  • Level of nurses' self-efficacy in obesity management(6 months)
  • Level of acceptance of the implementation of the intervention(6 months)
  • Level of the willingness of healthcare organizations to change clinical practice(6 months)

研究者

发起方
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
申办方类型
Other
责任方
Sponsor

研究点 (1)

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