Educational Interventions on Diabetic Foot Care

NCT04811989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Foundation for Science and Technology, Portugal

    collaborator OTHER
  • University of Minho

    lead OTHER

Principal Investigators

  • Gabriela Ferreira, Master · School of Psychology, University of Minho

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-12-15
Completion
2021-12-31

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04811989 on ClinicalTrials.gov