An interventional study of Evident 3 and Implementation strategy in Healthy Lifestyle and Nursing, sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Not applicable, Interventional, and Prevention
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.
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
STRUCTURE OF THE STUDY VISITS:
Pre-implementation visit: Inclusion criteria, explanation of the project, informed consent and baseline assessment of the study variables.
Assignment of study groups (intervention and control). Implementation: 4 training sessions in the intervention group . After these sessions, the implementation will be piloted in real conditions for a 6-months period.
Final visit: Post-implementation evaluation will be done at the end of the implementation (6 months) to evaluate changes in the study variables in both groups. A discussion group will be held in the intervention group to evaluate the experience of the implementation
Fundacion para la Investigacion y Formacion en Ciencias de la Salud is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Evident 3 · Other: Implementation strategy
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.
Device: Evident 3
It consists of brief 5-minute counselling on general physical activity recommendations and explaining the plate method for a balanced diet. Also, it includes the Evident 3 application, which is a daily dietary log that provides information on calories and diet composition and shows a reminder of the 10000 steps/day.
Four sessions have been designed to obtain the implementation strategy: First session: Presentation of the Evident 3 application and its results in clinical trials. Training in the use of the application and identification of possible areas for improvement. Second session: Presentation of evidence-based practices on the management of obesity in Primary Care. Consensus selection of those related to health promotion and mHealth. Sharing of possible lines of improvement of the care offered in the practice. Third session (optional): Intervention on those components (coherence, cognitive participation, collective action and reflective follow-up) of the NOMAD questionnaire, if very low scores are obtained. Fourth session: Brainstorming on possible strategies for the implementation of the Evident 3 intervention. Analysis and evaluation of these strategies and determination of a common strategy for their implementation.
Use of the intervention EVIDENT 3
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.
Time frame: 6 months
Number of obesity-related activities in primary health care
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.
Time frame: 6 months
Level of nurses' self-efficacy in obesity management
It will be evaluated by the Self-efficacy in obesity management Questionnaire, with 23 items on a Likert scale with 4 possible answers. This questionnaire has no cut-off point.
Time frame: 6 months
Level of acceptance of the implementation of the intervention
Measured with the Normalisation Measure Development questionnaire (NoMAD), which evaluates the implementation of complex health interventions. It consists of 23 questions grouped into four constructs: C1 Coherence (4 questions); C2 Cognitive involvement (4 questions); C3 Collective action (7 questions); C4 Reflective monitoring or "Evaluation"(5 questions) and 3 standardization questions.This questionnaire has no cut-off point.
Time frame: 6 months
Level of the willingness of healthcare organizations to change clinical practice
It will be evaluated with the Organizational Readiness for Knowledge Translation (OR4KT) questionnaire. It assesses 6 domains (organizational climate for change, contextual and organizational factors, change content, leadership, organizational support and motivation) through 59 items with a 5-choice Likert scale. A score greater than 64 indicates a greater willingness to change clinical practice.
Time frame: 6 months
Plan to share: Undecided
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Fundacion para la Investigacion y Formacion en Ciencias de la Salud