AzTrials
AzTrials

Diabetes MellitusNCT04811989

Educational Interventions on Diabetic Foot Care

A study testing Instructive video on diabetic foot care, Informative leaflet with real-time guided reading and Informative leaflet to read at home in people with Diabetes Mellitus and Diabetic Foot, run by University of Minho at 2 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Diabetic Foot
What is being tested?
Instructive video on diabetic foot care, Informative leaflet with real-time guided reading and Informative leaflet to read at home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesPortugal
Study dates
8 Mar 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Presence of clinical dementia described in the patient's clinical record;
  • Cognitive disability to answer the questionnaires;
  • Severe visual and/or hearing impairment.

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

  • Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa

    Penafiel, Porto District, 4564-007

  • Centro Hospitalar Universitário do Porto

    Porto, 4099-001

Other trials in Portugal

About this study

Official title: Impact of Educational Interventions on Diabetic Foot Self-care: A Pragmatic Randomized Controlled Trial

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.

Read the 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.

Being tested
Instructive video on diabetic foot care, Informative leaflet with real-time guided reading, Informative leaflet to read at home, Face-to-face teaching
Keywords
Education, Foot care adherence, Foot health, Knowledge, Illness representations, Health literacy, Video-based intervention, Informative Leaflet
Medical subject headings
Diabetes Mellitus, Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instructive video on diabetic foot careBehavioural

    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 readingBehavioural

    The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.

  • Informative leaflet to read at homeBehavioural

    Patients receive a leaflet about diabetic foot care to read at home.

  • Face-to-face teachingBehavioural

    Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.

Study groups in NCT04811989
Study groupRoleWhat they receive
Video Watching GroupExperimentalParticipants will watch an instructive video on diabetic foot care and will receive face-to-face teaching on diabetic foot care.
Receives: Behavioral: Instructive video on diabetic foot care; Behavioral: Face-to-face teaching
Real-time Leaflet Reading GroupExperimentalParticipants 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.
Receives: Behavioral: Informative leaflet with real-time guided reading; Behavioral: Face-to-face teaching
Standard Care GroupActive comparatorParticipants 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.
Receives: Behavioral: Informative leaflet to read at home; Behavioral: Face-to-face teaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Changes from baseline to two weeks post-test and after a three month follow-up

  2. 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.

    Measured: Changes from baseline to two weeks post-test and after a three month follow-up

  3. 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.

    Measured: Changes from baseline to two weeks post-test and after a three month follow-up

  4. 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.

    Measured: Changes from baseline to two weeks post-test and after a three month follow-up

Secondary outcomes (1)

  1. 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.

    Measured: Changes from baseline to two weeks post-test and after a three month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start8 Mar 2021
  3. Primary completion15 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811989
Sponsor's protocol ID
CEICVS134/2020
Status last verified
May 2022
First submitted
14 Mar 2021
Last updated
19 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17624279

  • 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.

    PubMed 9770933

  • 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.

    PubMed 20204931

  • 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.

    PubMed 19813683

  • 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.

    PubMed 25107513

  • 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.

    PubMed 22196195

  • 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.

    PubMed 10895844

Questions about this trial

What is this clinical trial studying?

A study testing Instructive video on diabetic foot care, Informative leaflet with real-time guided reading and Informative leaflet to read at home in people with Diabetes Mellitus and Diabetic Foot, run by University of Minho at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811989, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in