- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04623151
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
November 9, 2020 updated by: University of Chichester
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
452
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Sussex
-
Chichester, West Sussex, United Kingdom, PO19 6PE
- University of Chichester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online leaflet in narrative format
|
Short text-based leaflet about foot care, presented online
|
Active Comparator: Online leaflet in non-narrative format
|
Short text-based leaflet about foot care, presented online
|
No Intervention: No leaflet (control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Susan Churchill, PhD, University of Chichester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2017
Primary Completion (Actual)
August 16, 2018
Study Completion (Actual)
August 16, 2018
Study Registration Dates
First Submitted
October 16, 2017
First Submitted That Met QC Criteria
November 9, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOCMRPHDS3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared outside of the study team
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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