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Educational Interventions on Diabetic Foot Care

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ClinicalTrials.gov Identifier: NCT04811989
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
Foundation for Science and Technology, Portugal
Information provided by (Responsible Party):
Gabriela Ferreira, 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Foot Behavioral: Instructive video on diabetic foot care Behavioral: Informative leaflet with real-time guided reading Behavioral: Informative leaflet to read at home Behavioral: Face-to-face teaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
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.
Primary Purpose: Prevention
Official Title: Impact of Educational Interventions on Diabetic Foot Self-care: A Pragmatic Randomized Controlled Trial
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adherence to the diabetic foot care behaviours [ Time Frame: 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.

  2. Adherence to the diabetic foot care behaviours [ Time Frame: 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.

  3. Knowledge on foot care [ Time Frame: 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.

  4. General foot health [ Time Frame: 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 :
  1. Representations about diabetic foot [ Time Frame: 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:
  1. Foot pain [ Time Frame: 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.

  2. Foot function [ Time Frame: 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.

  3. Footwear [ Time Frame: 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.

  4. Clinical Data [ Time Frame: 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

  5. Health literacy [ Time Frame: Baseline (T0) ]
    Health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014).

  6. Sociodemographic data [ Time Frame: Baseline (T0) ]
    The sample will be characterized using a Sociodemographic Questionnaire developed for this study (e.g. age, marital status, gender, socio-economic level).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811989


Contacts
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Contact: Gabriela Ferreira, Master 926296063 ext +351 gabriela.m.m.ferreira@gmail.com
Contact: M.Graça Pereira, PhD 938471039 ext +351 gracep@psi.uminho.pt

Locations
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Portugal
Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa Recruiting
Penafiel, Porto, Portugal, 4564-007
Contact: Maria de Jesus Dantas, MD       70595@chts.min-saude.pt   
Centro Hospitalar Universitário do Porto Recruiting
Porto, Portugal, 4099-001
Contact: André Carvalho, PhD       andre.carvalho@chporto.min-saude.pt   
Sponsors and Collaborators
University of Minho
Foundation for Science and Technology, Portugal
Investigators
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Principal Investigator: Gabriela Ferreira, Master School of Psychology, University of Minho
Publications:
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

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Responsible Party: Gabriela Ferreira, Principal Investigator, Master, University of Minho
ClinicalTrials.gov Identifier: NCT04811989    
Other Study ID Numbers: CEICVS134/2020
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabriela Ferreira, University of Minho:
Education
Foot care adherence
Foot health
Knowledge
Illness representations
Health literacy
Video-based intervention
Informative Leaflet
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies