Educational Interventions on Diabetic Foot Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Specific Aims
-
To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time.
-
To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and perceived foot health.
-
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.
-
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 Design
Arms and Interventions
| 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: Informative leaflet with real-time guided reading
The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
Behavioral: Face-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
|
| 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: 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.
|
Outcome Measures
Primary Outcome Measures
- Adherence to the diabetic foot care behaviours [Changes from baseline to two weeks post-test and after a three month follow-up]
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.
- Adherence to the diabetic foot care behaviours [Changes from baseline to two weeks post-test and after a three month follow-up]
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.
- Knowledge on foot care [Changes from baseline to two weeks post-test and after a three month follow-up]
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.
- General foot health [Changes from baseline to two weeks post-test and after a three month follow-up]
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.
Secondary Outcome Measures
- Representations about diabetic foot [Changes from baseline to two weeks post-test and after a three month follow-up]
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.
Other Outcome Measures
- Foot pain [Baseline (T0), two weeks post-test (T1), three months follow-up (T2)]
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.
- Foot function [Baseline (T0), two weeks post-test (T1), three months follow-up (T2)]
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.
- Footwear [Baseline (T0), two weeks post-test (T1), three months follow-up (T2)]
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.
- Clinical Data [Baseline (T0)]
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
- Health literacy [Baseline (T0)]
Health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014).
- Sociodemographic data [Baseline (T0)]
The sample will be characterized using a Sociodemographic Questionnaire developed for this study (e.g. age, marital status, gender, socio-economic level).
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa | Penafiel | Porto | Portugal | 4564-007 |
| 2 | Centro Hospitalar Universitário do Porto | Porto | Portugal | 4099-001 |
Sponsors and Collaborators
- University of Minho
- Foundation for Science and Technology, Portugal
Investigators
- Principal Investigator: Gabriela Ferreira, Master, School of Psychology, University of Minho
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- CEICVS134/2020