Back to resultsWeb-based Support for People With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interactive web-based materials
Static web-based materials
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Diabetes, Health literacy, web intervention
Eligibility Criteria
Inclusion Criteria:
- Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interactive web-based materials
Static web-based materials
Arm Description
Interactive web-based materials for self-management of diabetes
Static version of the interactive web-based materials
Outcomes
Primary Outcome Measures
user engagement
Secondary Outcome Measures
Patient enablement
Website satisfaction
Physical activity attitudes and intentions
Diabetes and Physical activity knowledge
Full Information
NCT ID
NCT02122250
First Posted
March 21, 2013
Last Updated
December 2, 2015
Sponsor
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT02122250
Brief Title
Web-based Support for People With Type 2 Diabetes
Official Title
Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Health literacy, web intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1041 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interactive web-based materials
Arm Type
Experimental
Arm Description
Interactive web-based materials for self-management of diabetes
Arm Title
Static web-based materials
Arm Type
Active Comparator
Arm Description
Static version of the interactive web-based materials
Intervention Type
Behavioral
Intervention Name(s)
Interactive web-based materials
Intervention Description
Interactive web-based materials for self-management of diabetes
Intervention Type
Behavioral
Intervention Name(s)
Static web-based materials
Intervention Description
Static web-based materials
Primary Outcome Measure Information:
Title
user engagement
Time Frame
This will be measured by intervention completion rates
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Other Pre-specified Outcome Measures:
Title
Single item: whether you would recommend the website to others
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Yardley
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Web-based Support for People With Type 2 Diabetes
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