Diabetes Mellitus, Diabetic Foot
Conditions
Keywords
Education, Foot care adherence, Foot health, Knowledge, Illness representations, Health literacy, Video-based intervention, Informative Leaflet
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.
Interventions
BEHAVIORALInstructive 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
BEHAVIORALInformative leaflet with real-time guided reading
The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
BEHAVIORALInformative leaflet to read at home
Patients receive a leaflet about diabetic foot care to read at home.
BEHAVIORALFace-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
Sponsors
Foundation for Science and Technology, Portugal
University of Minho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Health literacy | Baseline (T0) | Health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014). |
| 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. |
| 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). |
| 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 |
Countries
Portugal
Outcome results
None listed