Educational Interventions on Diabetic Foot Care

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetic Foot
• Intervention / Treatment: Behavioral: Instructive video on diabetic foot care; Behavioral: Face-to-face teaching; Behavioral: Informative leaflet with real-time guided reading; Behavioral: Informative leaflet to read at home

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
  • Porto
    • Penafiel, Porto, Portugal, 4564-007
      • Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Video Watching Group; Participants will watch an instructive video on diabetic foot care and will receive face-to-face teaching on diabetic foot care.	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: Face-to-face teaching; Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
EXPERIMENTAL: Real-time Leaflet Reading Group; 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.	Behavioral: Face-to-face teaching; Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.; Behavioral: Informative leaflet with real-time guided reading; The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
ACTIVE_COMPARATOR: Standard Care Group; 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.	Behavioral: Face-to-face teaching; Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.; Behavioral: Informative leaflet to read at home; Patients receive a leaflet about diabetic foot care to read at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the diabetic foot care behaviours	Adherence to foot care behaviors will be assessed through the Nottingham Assessment of Functional Foot Care (Lincoln, Jeffcoate, Ince, Smith, & Radford, 2007). Composed of 29 items whose answers are given on a Likert scale ranging from 0 to 3. Higher scores correspond to a higher frequency of foot care behaviors.	Changes from baseline to two weeks post-test and after a three month follow-up
Adherence to the diabetic foot care behaviours	The level of foot self-care (indirect measure of adherence) will be assessed through the subscale of Foot Care of the Summary Diabetes Self-Care Activities Questionnaire (Original Version by Toobert, Hampson, & Glasgow, 2000; Portuguese Version by Bastos, Severo, & Lopes, 2007). Composed of 3 items in which patients are asked how many of the last seven days did they perform the respective foot care behaviour. Therefore, answers are given on a scale between 0 and 7, and its score is calculated through the mean number of days. Higher scores indicate higher levels of foot self-care.	Changes from baseline to two weeks post-test and after a three month follow-up
Knowledge on foot care	Knowledge on foot care will be assessed through the Questionnaire on Knowledge of Foot Care (Hasnain & Sheikh, 2009). Each correct answer is scored with 1 point and higher scores indicate better knowledge about foot care.	Changes from baseline to two weeks post-test and after a three month follow-up
General foot health	General foot health will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to the perception of poor foot health state/condition and 100 to the perception of excellent foot health.	Changes from baseline to two weeks post-test and after a three month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Representations about diabetic foot	Representations about diabetic foot will be assessed through the Illness Perception Questionnaire - Brief (IPQ-B; Figueiras et al., 2010). The response scale ranges from 0 to 10. Higher scores indicate more threatening representations regarding diabetic foot.	Changes from baseline to two weeks post-test and after a three month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot pain	Foot pain will be assessed through the respective subscale of the Foot Health Status Questionnaire (Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to significant or extreme foot pain and 100 to no foot pain or discomfort.	Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
Foot function	Foot function will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to severe limitation in the performance of physical activities because of the feet and 100 to no limitation.	Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
Footwear	Footwear will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, & Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to severe problems obtaining appropriate footwear and 100 to no problems.	Baseline (T0), two weeks post-test (T1), three months follow-up (T2)
Clinical Data	Clinical variables (e.g., HbA1c levels, presence/absence of active ulcer and duration of diabetic foot ulcer, recommendation to use therapeutic footwear) will be assessed through a Clinical Questionnaire developed for this study	Baseline (T0)
Health literacy	Health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014).	Baseline (T0)
Sociodemographic data	The sample will be characterized using a Sociodemographic Questionnaire developed for this study (e.g. age, marital status, gender, socio-economic level).	Baseline (T0)

Collaborators and Investigators

• Sponsor: University of Minho
• Collaborators: Foundation for Science and Technology, Portugal
• Investigators: Principal Investigator: Gabriela Ferreira, Master, School of Psychology, University of Minho

Publications and helpful links

General Publications

• Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.
• Bastos F, Severo M, Lopes C. [Psychometric analysis of diabetes self-care scale (translated and adapted to Portuguese)]. Acta Med Port. 2007 Jan-Feb;20(1):11-20. Epub 2007 May 23. Portuguese.
• Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
• Hasnain S, Sheikh NH. Knowledge and practices regarding foot care in diabetic patients visiting diabetic clinic in Jinnah Hospital, Lahore. J Pak Med Assoc. 2009 Oct;59(10):687-90.
• Lincoln, N. B., Jeffcoate, W. J., Ince, P., Smith, M., & Radford, K. A. (2007). Validation of a new measure of protective footcare behaviour: the Nottingham Assessment of Functional Footcare (NAFF). Practical Diabetes International, 24, 207-211. doi:10.1002/pdi.1099
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2021
• Primary Completion (ACTUAL): December 15, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 20, 2021
• First Posted (ACTUAL): March 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Education; Knowledge; Health literacy; Foot care adherence; Foot health; Illness representations; Video-based intervention; Informative Leaflet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: CEICVS134/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No