Study Results
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Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2021-03-08
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Video Watching Group
Participants will watch an instructive video on diabetic foot care and will receive face-to-face teaching on diabetic foot care.
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
Face-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
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.
Informative leaflet with real-time guided reading
The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
Face-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
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.
Informative leaflet to read at home
Patients receive a leaflet about diabetic foot care to read at home.
Face-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
Interventions
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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
Informative leaflet with real-time guided reading
The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
Informative leaflet to read at home
Patients receive a leaflet about diabetic foot care to read at home.
Face-to-face teaching
Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cognitive disability to answer the questionnaires;
* Severe visual and/or hearing impairment.
18 Years
ALL
No
Sponsors
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Foundation for Science and Technology, Portugal
OTHER
University of Minho
OTHER
Responsible Party
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Gabriela Ferreira
Principal Investigator, Master
Principal Investigators
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Gabriela Ferreira, Master
Role: PRINCIPAL_INVESTIGATOR
School of Psychology, University of Minho
Locations
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Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
Penafiel, Porto District, Portugal
Centro Hospitalar Universitário do Porto
Porto, , Portugal
Countries
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References
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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. doi: 10.7547/87507315-88-9-419.
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. No abstract available.
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.
Other Identifiers
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CEICVS134/2020
Identifier Type: -
Identifier Source: org_study_id
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