Educational Interventions on Diabetic Foot Care
- Conditions
- Diabetes MellitusDiabetic Foot
- Interventions
- Behavioral: Informative leaflet with real-time guided readingBehavioral: Informative leaflet to read at homeBehavioral: Instructive video on diabetic foot careBehavioral: Face-to-face teaching
- Registration Number
- NCT04811989
- Lead Sponsor
- University of Minho
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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.
- Presence of clinical dementia described in the patient's clinical record;
- Cognitive disability to answer the questionnaires;
- Severe visual and/or hearing impairment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real-time Leaflet Reading Group Informative leaflet with real-time guided reading 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. Standard Care Group Informative leaflet to read at home 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. Standard Care Group Face-to-face teaching 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. Video Watching Group Instructive video on diabetic foot care Participants will watch an instructive video on diabetic foot care and will receive face-to-face teaching on diabetic foot care. Video Watching Group Face-to-face teaching Participants will watch an instructive video on diabetic foot care and will receive face-to-face teaching on diabetic foot care. Real-time Leaflet Reading Group Face-to-face teaching 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
ClÃnica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
🇵🇹Penafiel, Porto, Portugal
Centro Hospitalar Universitário do Porto
🇵🇹Porto, Portugal