Clinical trial NCT04811989: Educational Interventions on Diabetic Foot Care
Official title: Impact of Educational Interventions on Diabetic Foot Self-care: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Foot
Keywords: Education
Foot care adherence
Foot health
Knowledge
Illness representations
Health literacy
Video-based intervention
Informative Leaflet
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2021-03-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized at a ratio of 1:1 for the two conditions - Video Watching Group or Real-time Leaflet Reading Group versus Standard Care Group - into blocks of variable size, multiples of two. This randomization will be stratified according to the hospital (hospital 1 versus hospital 2) and the presence or absence of active diabetic foot ulcer.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to the diabetic foot care behaviours
timeFrame: Changes from baseline to two weeks post-test and after a three month follow-up
measure: Adherence to the diabetic foot care behaviours
timeFrame: Changes from baseline to two weeks post-test and after a three month follow-up
measure: Knowledge on foot care
timeFrame: Changes from baseline to two weeks post-test and after a three month follow-up
measure: General foot health
timeFrame: Changes from baseline to two weeks post-test and after a three month follow-up
Secondary outcomes:
measure: Representations about diabetic foot
timeFrame: Changes from baseline to two weeks post-test and after a three month follow-up
Other outcomes:
measure: Foot pain
timeFrame: Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
measure: Foot function
timeFrame: Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
measure: Footwear
timeFrame: Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
measure: Clinical Data
timeFrame: Baseline (T0)
measure: Health literacy
timeFrame: Baseline (T0)
measure: Sociodemographic data
timeFrame: Baseline (T0)
Locations:
city: Penafiel
country: Portugal
facility: Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
state: Porto
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto
Study officials:
affiliation: School of Psychology, University of Minho
name: Gabriela Ferreira, Master
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Paiva D, Silva S, Severo M, Ferreira P, Santos O, Lunet N, Azevedo A. Cross-cultural adaptation and validation of the health literacy assessment tool METER in the Portuguese adult population. Patient Educ Couns. 2014 Nov;97(2):269-75. doi: 10.1016/j.pec.2014.07.024. Epub 2014 Jul 22.
citation: Pandis N. Randomization. Part 3: allocation concealment and randomization implementation. Am J Orthod Dentofacial Orthop. 2012 Jan;141(1):126-8. doi: 10.1016/j.ajodo.2011.09.003. No abstract available.
citation: Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.