Primary Care Research Unit of Salamanca
Salamanca, 37005, Spain
NCT Number: NCT05506436
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.
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Interventional
Not applicable
Salamanca, 37005, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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
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
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.
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Other
Evaluation of an Implementation Strategy of mHealth Intervention for the Promotion of Healthy Lifestyles in Primary Healthcare (E-VIDAPP Pilot Study)
Acronym: E-VIDAPP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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