- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961517
Format of Patient Education for Different Sociodemographic Groups
February 25, 2022 updated by: University of Leicester
The Influence of Socio-demographic Characteristics on the Preferred Format of Patient Education Delivery in Individuals With Type 2 Diabetes Mellitus or Cardiovascular Disease: a Questionnaire Study
Questionnaire study to investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery, for patients with diabetes and/or cardiovascular disease
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
An anonymous questionnaire will be used to collect basic demographic data for patients with the conditions of interest, in addition to information about their preferences for the format in which they receive patient education information. This data will be statistically analysed to address the primary and secondary outcomes of the study:
- To investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery.
- To identify reasons for preference of patient education delivery, and whether these are associated with sociodemographic factors.
- To assess the distribution of sociodemographic factors from participants who prefer online education, in order to identify whether preference for online education is associated with particular sociodemographic factors.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lois Daniels, MBBS
- Phone Number: 01162588070
- Email: Lois.J.Daniels@uhl-tr.nhs.uk
Study Locations
-
-
-
Leicester, United Kingdom, LE5 4PW
- Recruiting
- Leicester Diabetes Centre
-
Contact:
- Lois Daniels
- Phone Number: 01162588070
- Email: Lois.J.Daniels@uhl-tr.nhs.uk
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any patient aged 18 years or over, Diagnosed with cardiovascular disease (defined as heart disease, peripheral vascular disease or stroke) or Type 2 diabetes who has not already completed the questionnaire and is able and willing to complete questionnaire
Description
Inclusion Criteria:
- Aged 18 years or over.
- Diagnosed with cardiovascular disease (defined as heart disease, peripheral vascular disease or stroke) or Type 2 diabetes
- Has not already completed the questionnaire
- Able and willing to complete questionnaire
Exclusion Criteria:
- Participant unable or unwilling to complete questionnaire
- Under the age of 18
- Not diagnosed with any of the conditions of interest
- Participant has already completed the questionnaire
- Unable to communicate (assisted or otherwise) in written English
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
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
All patients with type 2 diabetes and/or cardiovascular disease who will complete the questionnaire
|
Anonymous questionnaire collecting basic sociodemographic data about the participant and information regarding their preferences for the method of delivery format of patient education information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of sociodemographic characteristics
Time Frame: 9 Months
|
To investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery.
|
9 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reasons for preferences
Time Frame: 9 months
|
To identify reasons for preference of patient education delivery, and whether these are associated with sociodemographic factors.
|
9 months
|
Preference for online
Time Frame: 9 months
|
To assess the distribution of sociodemographic factors from participants who prefer online education, in order to identify whether preference for online education is associated with particular sociodemographic factors.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2016
Primary Completion (Anticipated)
April 30, 2022
Study Completion (Anticipated)
April 30, 2022
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 8, 2016
First Posted (Estimate)
November 11, 2016
Study Record Updates
Last Update Posted (Actual)
February 28, 2022
Last Update Submitted That Met QC Criteria
February 25, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0594
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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