Web-based Support for People With Type 2 Diabetes

NCT02122250 | Completed

• 1 other identifier: 4746
• Study Type: interventional
• Target: 1,041
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Health literacy; web intervention

Outcome Measures

Primary Outcomes (1)

• user engagement

  This will be measured by intervention completion rates

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Other Outcomes (1)

• 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.

Study Arms (2)

Interactive web-based materials

EXPERIMENTAL

Interactive web-based materials for self-management of diabetes

Behavioral: Interactive web-based materials

Static web-based materials

ACTIVE COMPARATOR

Static version of the interactive web-based materials

Behavioral: Static web-based materials

Interventions

Interactive web-based materials BEHAVIORAL

Interactive web-based materials for self-management of diabetes

Interactive web-based materials

Static web-based materials BEHAVIORAL

Static web-based materials

Static web-based materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southampton: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lucy Yardley

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 24, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12