Educational Interventions on Diabetic Foot Care
NCT04811989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2022-05-19
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
- Diabetes Mellitus
- Diabetic Foot
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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