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Clinical Trials/NCT01565824
NCT01565824
Completed
N/A

Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)

Göteborg University1 site in 1 country174 target enrollmentNovember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Type 1
Sponsor
Göteborg University
Enrollment
174
Locations
1
Primary Endpoint
Diabetes Empowerment Scale (SWE-DES-10)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim is to investigate whether the implementation of a web-based support to women with type 1 diabetes during pregnancy and early motherhood can improve well-being and self management of diabetes. Type 1 diabetes is associated with increased medical risks and increased psychosocial pressure in relation to childbearing. There is need for extended support from both health care professionals and peers. Web-based interventions can improve personal capacity and self-management in people with long- term illnesses but are not evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size browsers and mobile devices has been developed through a participatory design by multidisciplinary researchers, health care professionals, experienced mothers with type 1 diabetes and web designers. In a randomised control study the developed web site offering information, communication with health care professionals, person-centred self-care diaries and online social community of included women, is provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A control group will receive standard care (usual care). Total n = 160. Primary outcomes are Well-Being Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive solutions for strengthening patients' decision making of diabetes in daily life during pregnancy and early motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of diabetes.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
March 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • women with type 12 diabetes, included in early pregnancy (first trimester)

Exclusion Criteria

  • women who are illiterate, or do not read and speak Swedish

Outcomes

Primary Outcomes

Diabetes Empowerment Scale (SWE-DES-10)

Time Frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion

Well-Being Questionnaire (W-BQ12)

Time Frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion

Study Sites (1)

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