NCT04811989

Educational Interventions on Diabetic Foot Care

Impact of Educational Interventions on Diabetic Foot Self-care: A Pragmatic Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Minho · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus
• Diabetic Foot

Interventions

Type	Name	Description
BEHAVIORAL	Instructive video on diabetic foot care	In the video, the diabetic foot care is presented verbally and appropriately captioned, as well as exemplified by real patients and health professionals from the hospital
BEHAVIORAL	Informative leaflet with real-time guided reading	The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
BEHAVIORAL	Informative leaflet to read at home	Patients receive a leaflet about diabetic foot care to read at home.
BEHAVIORAL	Face-to-face teaching	Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-12-15
• Completion: 2021-12-31
• First posted: 2021-03-23
• Last updated: 2022-05-19

Locations

2 sites across 1 country: Portugal