Web-based Support for People With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122250
• Other study ID #: 4746
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: December 2, 2015
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1041
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Interactive web-based materials
Interactive web-based materials for self-management of diabetes
• Static web-based materials
Static web-based materials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single item: whether you would recommend the website to others		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.	No
Primary	user engagement		This will be measured by intervention completion rates	No
Secondary	Patient enablement		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.	No
Secondary	Website satisfaction		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.	No
Secondary	Physical activity attitudes and intentions		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.	No
Secondary	Diabetes and Physical activity knowledge		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.	No