Educational Interventions on Diabetic Foot Care

NCT04811989 | Completed

• 1 other identifier: CEICVS134/2020
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Diabetic Foot

Keywords

Education; Foot care adherence; Foot health; Knowledge; Illness representations; Health literacy; Video-based intervention; Informative Leaflet

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Representations about diabetic foot

  Changes from baseline to two weeks post-test and after a three month follow-up

Other Outcomes (6)

• Foot pain

  Baseline (T0), two weeks post-test (T1), three months follow-up (T2)

• Foot function

  Baseline (T0), two weeks post-test (T1), three months follow-up (T2)

• Footwear

  Baseline (T0), two weeks post-test (T1), three months follow-up (T2)

Study Arms (3)

Video Watching Group

EXPERIMENTAL

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; Behavioral: Face-to-face teaching

Real-time Leaflet Reading Group

EXPERIMENTAL

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: Informative leaflet with real-time guided reading; Behavioral: Face-to-face teaching

Standard Care Group

ACTIVE COMPARATOR

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: Informative leaflet to read at home; Behavioral: Face-to-face teaching

Interventions

Instructive video on diabetic foot care BEHAVIORAL

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

Video Watching Group

Informative leaflet with real-time guided reading BEHAVIORAL

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

Real-time Leaflet Reading Group

Informative leaflet to read at home BEHAVIORAL

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

Standard Care Group

Face-to-face teaching BEHAVIORAL

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

Real-time Leaflet Reading Group; Standard Care Group; Video Watching Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minho: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (2)

Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa

Penafiel, Porto District, 4564-007, Portugal

Location

Centro Hospitalar Universitário do Porto

Porto, 4099-001, Portugal

Location

Related Publications (8)

• 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.

  PMID: 17624279 BACKGROUND

• 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.

  PMID: 9770933 BACKGROUND

• 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.

  PMID: 20204931 BACKGROUND

• 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.

  PMID: 19813683 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25107513 BACKGROUND

• 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.

  PMID: 22196195 BACKGROUND

• 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.

  PMID: 10895844 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Officials

• Gabriela Ferreira, Master

  School of Psychology, University of Minho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomisation will be performed through an online random number generator, by a researcher external to the team of this study, to ensure the concealment of the allocation of participants by the several groups (Pandis, 2012). It will not be possible to conceal the group to which the patient was allocated to the medical and nursing team, since they have to administer the intervention or the researcher who will have to inform the respective team and administer the intervention in the Reading Group. Only the participants will be blind to the group to which they have been allocated.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 23, 2021
• Study Start: March 8, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)