Type 2 DiabetesNCT02122250
Web-based Support for People With Type 2 Diabetes
A study testing Interactive web-based materials and Static web-based materials in people with Type 2 Diabetes, run by University of Southampton.
Trial summary
This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Interactive web-based materials and Static web-based materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,041 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Nov 2015
- Phase
- Interventional
- 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
Who may be able to join
- Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.
Who cannot join
- Severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak English.
About this study
Official title: Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes
This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy.
This study will be carried out two phases. Phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. Phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online.
- Conditions
- Type 2 Diabetes
- Being tested
- Interactive web-based materials, Static web-based materials
- Keywords
- Diabetes, Health literacy, web intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive web-based materialsBehavioural
Interactive web-based materials for self-management of diabetes
Static web-based materialsBehavioural
Static web-based materials
| Study group | Role | What they receive |
|---|---|---|
| Interactive web-based materials | Experimental | Interactive web-based materials for self-management of diabetes Receives: Behavioral: Interactive web-based materials |
| Static web-based materials | Active comparator | Static version of the interactive web-based materials Receives: Behavioral: Static web-based materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
user engagement
Measured: This will be measured by intervention completion rates
Secondary outcomes (4)
Patient enablement
Measured: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Website satisfaction
Measured: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Physical activity attitudes and intentions
Measured: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Diabetes and Physical activity knowledge
Measured: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Yardley, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122250
- Sponsor's protocol ID
- 4746
- Status last verified
- Dec 2015
- First submitted
- 21 Mar 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes
- ClinicalTrials.gov ID
- NCT02122250
- Acronym / sponsor ID
- 4746
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Health literacy, web intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Apr 2014 (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.
This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy.
This study will be carried out two phases. Phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. Phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive web-based materials | Experimental | Behavioral: Interactive web-based materialsInteractive web-based materials for self-management of diabetes |
| Static web-based materials | Active comparator | Behavioral: Static web-based materialsStatic version of the interactive web-based materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.
Key exclusion criteria (1 listed)
- Severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak 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 |
|---|---|---|
| Interactive web-based materialsInteractive web-based materials for self-management of diabetes | Behavioural | Interactive web-based materials |
| Static web-based materialsStatic web-based materials | Behavioural | Static web-based materials |
Primary outcome
user engagement
Time frame: This will be measured by intervention completion rates
4 secondary outcomes
Patient enablement
Time frame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Website satisfaction
Time frame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Physical activity attitudes and intentions
Time frame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Diabetes and Physical activity knowledge
Time frame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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.
Lucy Yardley principal investigator
University of Southampton
Questions about this trial
What is this clinical trial studying?
A study testing Interactive web-based materials and Static web-based materials in people with Type 2 Diabetes, run by University of Southampton.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
user engagement (time frame: This will be measured by intervention completion rates). 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 3 Dec 2015.