Educational Interventions on Diabetic Foot Care

University of Minho

Status: Completed

Conditions: Diabetic Foot; Diabetes Mellitus

Treatments: Behavioral: Informative leaflet to read at home; Behavioral: Informative leaflet with real-time guided reading; Behavioral: Instructive video on diabetic foot care; Behavioral: Face-to-face teaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04811989

CEICVS134/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Diabetes mellitus;
• Diagnosis of Diabetic Foot;
• To benefit from the first assessment and follow-up at the Multidisciplinary Diabetic Foot Consultation of the hospitals where data collection will take place.

Exclusion criteria

• Presence of clinical dementia described in the patient's clinical record;
• Cognitive disability to answer the questionnaires;
• Severe visual and/or hearing impairment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

71 participants in 3 patient groups

Video Watching Group

Experimental group

Description:

Participants will watch an instructive video on diabetic foot care and will receive face-to-face teaching on diabetic foot care.

Treatment:

Behavioral: Instructive video on diabetic foot care

Behavioral: Face-to-face teaching

Real-time Leaflet Reading Group

Experimental group

Description:

Participants will receive a leaflet with diabetic foot care information, whose reading will be guided in real-time by the Researcher, and will also receive face-to-face teaching on diabetic foot care.

Treatment:

Behavioral: Informative leaflet with real-time guided reading

Behavioral: Face-to-face teaching

Standard Care Group

Active Comparator group

Description:

Participants will receive the standard care that includes face-to-face teaching about diabetic foot care and will take a leaflet on diabetic foot care to read at home.

Treatment:

Behavioral: Informative leaflet to read at home

Behavioral: Face-to-face teaching