Other Clinical Trial - Educational Interventions on Diabetic Foot Care

Status Completed

Clinical Trial Summary

Diabetes mellitus currently affects 463 million people worldwide. One of the most serious complications of diabetes is the diabetic foot. Adequate foot care behaviours reduce the risk of ulcers, infections, and amputations, and improve the quality of life, in these patients. This Pragmatic Randomized Controlled Trial aims to analyse the impact of different educational strategies - an instructive video (Video Watching Group - Experimental Group 1) compared with a leaflet on foot care with real-time guided reading (Real-Time Leaflet Reading Group - Experimental Group 2) and with standard teaching on diabetic foot care (Standard Care - Control Group) - on adherence and knowledge regarding diabetic foot care, as well as on patient's perception of their foot health. 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, after obtaining the patients' consent. The results of the present study will inform educational interventions regarding foot care adherence in patients with diabetic foot, in order to decrease the likelihood of developing diabetic foot ulcers and, consequently, to reduce amputation rates and the several associated costs, contributing to improving patients' quality of life.

Clinical Trial Description

Specific Aims 1. To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time. 2. To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and perceived foot health. 3. 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. 4. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04811989
Study type	Interventional
Source	University of Minho
Contact
Status	Completed
Phase	N/A
Start date	March 8, 2021
Completion date	December 31, 2021

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