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

  • United Kingdom
    • 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
Behavioral: Online leaflet about foot care
Short text-based leaflet about foot care, presented online
Active Comparator: Online leaflet in non-narrative format
Behavioral: Online leaflet about foot care
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

University of Chichester

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

Keywords

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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