Type2 Diabetes MellitusNCT02961517
Format of Patient Education for Different Sociodemographic Groups
An observational study of Type2 Diabetes Mellitus and Cardiovascular Diseases, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leicester Diabetes Centre
Leicester, LE5 4PW
Lois Daniels, 01162588070, Lois.J.Daniels@uhl-tr.nhs.uk
About this study
Official title: 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
Read the 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.
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Questionnaire
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Anonymous questionnaire collecting basic sociodemographic data about the participant and information regarding their preferences for the method of delivery format of patient education information
| Study group | Role | What they receive |
|---|---|---|
| Patients | All patients with type 2 diabetes and/or cardiovascular disease who will complete the questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of sociodemographic characteristics
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.
Measured: 9 Months
Secondary outcomes (2)
Reasons for preferences
To identify reasons for preference of patient education delivery, and whether these are associated with sociodemographic factors.
Measured: 9 months
Preference for online
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961517
- Sponsor's protocol ID
- 0594
- Status last verified
- Feb 2022
- First submitted
- 8 Nov 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02961517
- Acronym / sponsor ID
- 0594
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnaireAll patients with type 2 diabetes and/or cardiovascular disease who will complete the questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAnonymous questionnaire collecting basic sociodemographic data about the participant and information regarding their preferences for the method of delivery format of patient education information | Other | Patients |
Primary outcome
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.
2 secondary outcomes
Reasons for preferences
Time frame: 9 months
Preference for online
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes Mellitus and Cardiovascular Diseases, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lois Daniels, MBBS (01162588070, Lois.J.Daniels@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of sociodemographic characteristics (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.