An interventional study of Instructive video on diabetic foot care and Informative leaflet with real-time guided reading in Diabetes Mellitus and Diabetic Foot, sponsored by University of Minho. Completed at 2 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by University of Minho · Not applicable, Interventional, and Prevention
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.
Specific Aims
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 71 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University of Minho is the lead sponsor of 37 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
Patients receive a leaflet about diabetic foot care to read at home.
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Changes from baseline to two weeks post-test and after a three month follow-up
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.
Time frame: Changes from baseline to two weeks post-test and after a three month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline (T0)
Health literacy
Health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014).
Time frame: 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).
Time frame: Baseline (T0)
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minho