NCT04623151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2018

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

October 16, 2017

Last Update Submit

November 9, 2020

Conditions

Keywords

Foot carenarrativediabeteshealth behaviourhealth psychology

Outcome Measures

Primary Outcomes (1)

  • 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

    1 week

Study Arms (3)

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

Interventions

Short text-based leaflet about foot care, presented online

Online leaflet in narrative formatOnline leaflet in non-narrative format

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chichester

Chichester, West Sussex, PO19 6PE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetic FootHealth BehaviorFoot DiseasesNarrationDiabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesBehaviorMusculoskeletal DiseasesCommunicationGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Susan Churchill, PhD

    University of Chichester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

November 10, 2020

Study Start

August 16, 2017

Primary Completion

August 16, 2018

Study Completion

August 16, 2018

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

IPD will not be shared outside of the study team

Locations