Educational Interventions on Diabetic Foot Care
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus
- Diabetic Foot
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomized at a ratio of 1:1 for the two conditions - Video Watching Group or Real-time Leaflet Reading Group versus Standard Care Group - into blocks of variable size, multiples of two. This randomization will be stratified according to the hospital (hospital 1 versus hospital 2) and the presence or absence of active diabetic foot ulcer.Masking: Single (Participant)Masking Description: Randomisation will be performed through an online random number generator, by a researcher external to the team of this study, to ensure the concealment of the allocation of participants by the several groups (Pandis, 2012). It will not be possible to conceal the group to which the patient was allocated to the medical and nursing team, since they have to administer the intervention or the researcher who will have to inform the respective team and administer the intervention in the Reading Group. Only the participants will be blind to the group to which they have been allocated.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Specific Aims To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time. To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and p...
Specific Aims To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time. To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and perceived foot health. To examine the mediating role of representations about diabetic foot in the relationship between knowledge about foot care and adherence to diabetic foot care, over time, controlling for health literacy. To examine the moderating role of foot pain, foot function, and footwear between representations about diabetic foot and adherence to diabetic foot care/ perceived foot health, over time. Data Analysis: Generalized Mixed Models, which allow examining changes over time including longitudinal mediation and moderation. Sample size calculation: Considering a dropout rate of 10%, the sample size required is 60 patients (20 per group). Procedure: Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls.
Tracking Information
- NCT #
- NCT04811989
- Collaborators
- Foundation for Science and Technology, Portugal
- Investigators
- Principal Investigator: Gabriela Ferreira, Master School of Psychology, University of Minho
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