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NCT01565824 Clinical Trial

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

Pregnancy Clinical Trial

— MODIAB-web  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01565824
Other study ID # MODIAB-web
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date March 2016

Study information
Verified date March 2019
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• web-based support

Locations
Country Name City State
Sweden Sahlgrenska Academy, Institute of Health Care Sciences Gothenburg

Sponsors (3)
Lead Sponsor Collaborator
Göteborg University Swedish Diabetes Association, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diabetes Empowerment Scale (SWE-DES-10) at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
Primary Well-Being Questionnaire (W-BQ12) at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
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