Back to resultsManipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
Primary Purpose
Diabetic Foot, Health Behavior, Foot Diseases
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online leaflet about foot care
Sponsored by
About this trial
This is an interventional health services research trial for Diabetic Foot focused on measuring Foot care, narrative, diabetes, health behaviour, health psychology
Eligibility Criteria
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
Sites / Locations
- University of Chichester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Online leaflet in narrative format
Online leaflet in non-narrative format
No leaflet (control)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04623151
First Posted
October 16, 2017
Last Updated
November 9, 2020
Sponsor
University of Chichester
1. Study Identification
Unique Protocol Identification Number
NCT04623151
Brief Title
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
Official Title
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chichester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Health Behavior, Foot Diseases
Keywords
Foot care, narrative, diabetes, health behaviour, health psychology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Online leaflet about foot care in a narrative format
Online leaflet about foot care in a non-narrative format
No leaflet (control)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online leaflet in narrative format
Arm Type
Experimental
Arm Title
Online leaflet in non-narrative format
Arm Type
Active Comparator
Arm Title
No leaflet (control)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Online leaflet about foot care
Intervention Description
Short text-based leaflet about foot care, presented online
Primary Outcome Measure Information:
Title
5-item Foot Care Detection Behaviour Scale
Description
Questionnaire asking participants how many days in the past 7 they have checked their feet to detect cuts, blisters, sores, calluses, and red patches
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Churchill, PhD
Organizational Affiliation
University of Chichester
Official's Role
Study Director
Facility Information:
Facility Name
University of Chichester
City
Chichester
State/Province
West Sussex
ZIP/Postal Code
PO19 6PE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared outside of the study team
Links:
URL
https://chichpscyh.eu.qualtrics.com/jfe/form/SV_eCF14PjJGVN0nGt
Description
Online survey
Learn more about this trial
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
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