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Web-based Support for People With Type 2 Diabetes

NCT ID: NCT02122250

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1041 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Interactive web-based materials

Interactive web-based materials for self-management of diabetes

Group Type EXPERIMENTAL

Interactive web-based materials

Intervention Type BEHAVIORAL

Interactive web-based materials for self-management of diabetes

Static web-based materials

Static version of the interactive web-based materials

Group Type ACTIVE_COMPARATOR

Static web-based materials

Intervention Type BEHAVIORAL

Static web-based materials

Interventions

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Interactive web-based materials

Interactive web-based materials for self-management of diabetes

Intervention Type BEHAVIORAL

Static web-based materials

Static web-based materials

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucy Yardley

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Other Identifiers

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4746

Identifier Type: -

Identifier Source: org_study_id