CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Instructive video on diabetic foot care +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04811989
NCT04811989N/ACompleted

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

University of Minho·interventional·Posted Mar 23, 2021·Updated May 19, 2022

In Brief

A clinical study evaluating Instructive video on diabetic foot care, Informative leaflet with real-time guided reading, and 2 other interventions for Diabetes Mellitus and Diabetic Foot. Completed, enrolled 71 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 23, 2021
Enrollment StartMar 8, 2021
Primary CompletionDec 15, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago

Interventions

Instructive video on diabetic foot carebehavioral

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

Informative leaflet with real-time guided readingbehavioral

The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.

Informative leaflet to read at homebehavioral

Patients receive a leaflet about diabetic foot care to read at home.

Face-to-face teachingbehavioral

Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.