Diabetic FootNCT04623151
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
A study testing Online leaflet about foot care in people with Diabetic Foot and Health Behavior, run by University of Chichester at 1 site in United Kingdom.
Trial summary
The study explores the role of health messages (narrative, non-narrative vs. control condition [no message]) to enhance good foot care practices among people with diabetes and the general population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Health Behavior, Foot Diseases
- What is being tested?
- Online leaflet about foot care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Aug 2017to 16 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age at the time of consent;
- able to read and speak the English language;
- able and willing to give written informed consent prior to study entry;
- able to complete the protocol requirements
Who cannot join
- has a cognitive impairment or acute psychopathology (self-reported formal diagnoses of down syndrome, traumatic brain injury, brain tumour, autism, dementia, schizophrenia, and/or schizoaffective disorder), ie that which could interfere with his or her ability to provide written consent and complete the study
- has taken part in any other research on foot care with the University of Chichester in the past year
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Chichester
Chichester, West Sussex, PO19 6PE
About this study
The study explores the role of health messages (narrative, non-narrative vs. control condition [no message]) to enhance good foot care practices among people with diabetes and the general population.
- Conditions
- Diabetic Foot, Health Behavior, Foot Diseases
- Being tested
- Online leaflet about foot care
- Keywords
- Foot care, narrative, diabetes, health behaviour, health psychology
- Medical subject headings
- Diabetic Foot, Health Behavior, Foot Diseases, Narration, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online leaflet about foot careBehavioural
Short text-based leaflet about foot care, presented online
| Study group | Role | What they receive |
|---|---|---|
| Online leaflet in narrative format | Experimental | Not described Receives: Behavioral: Online leaflet about foot care |
| Online leaflet in non-narrative format | Active comparator | Not described Receives: Behavioral: Online leaflet about foot care |
| No leaflet (control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-item Foot Care Detection Behaviour Scale
Questionnaire asking participants how many days in the past 7 they have checked their feet to detect cuts, blisters, sores, calluses, and red patches
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start16 Aug 2017
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Online leaflet about foot care in a narrative format 2. Online leaflet about foot care in a non-narrative format 3. No leaflet (control)
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chichester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Churchill, PhD, Study director, University of Chichester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623151
- Sponsor's protocol ID
- UOCMRPHDS3
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of the study team
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04623151
- Acronym / sponsor ID
- UOCMRPHDS3
- Conditions
- Diabetic Foot, Health Behavior, Foot Diseases
- Keywords
- Foot care, narrative, diabetes, health behaviour, health psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of ChichesterUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study explores the role of health messages (narrative, non-narrative vs. control condition [no message]) to enhance good foot care practices among people with diabetes and the general population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Online leaflet about foot care in a narrative format 2. Online leaflet about foot care in a non-narrative format 3. No leaflet (control)
| Arm | Type | Receives |
|---|---|---|
| Online leaflet in narrative format | Experimental | Behavioral: Online leaflet about foot care |
| Online leaflet in non-narrative format | Active comparator | Behavioral: Online leaflet about foot care |
| No leaflet (control) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years of age at the time of consent;
- able to read and speak the English language;
- able and willing to give written informed consent prior to study entry;
- able to complete the protocol requirements
Key exclusion criteria (2 listed)
- has a cognitive impairment or acute psychopathology (self-reported formal diagnoses of down syndrome, traumatic brain injury, brain tumour, autism, dementia, schizophrenia, and/or schizoaffective disorder), ie that which could interfere with his or her ability to provide written consent and complete the study
- has taken part in any other research on foot care with the University of Chichester in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online leaflet about foot careShort text-based leaflet about foot care, presented online | Behavioural | Online leaflet in narrative format, Online leaflet in non-narrative format |
Primary outcome
5-item Foot Care Detection Behaviour Scale
Time frame: 1 week
Questionnaire asking participants how many days in the past 7 they have checked their feet to detect cuts, blisters, sores, calluses, and red patches
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Online surveyLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared outside of the study team
Related trials for Diabetic Foot
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Churchill, PhD study director
University of Chichester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online leaflet about foot care in people with Diabetic Foot and Health Behavior, run by University of Chichester at 1 site in United Kingdom.
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 4 inclusion and 2 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
5-item Foot Care Detection Behaviour Scale (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2020.