Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)
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Purpose
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 will be 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, will be provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at two hospitals. A control group will receive standard 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.
| Condition | Intervention |
|---|---|
|
Diabetes Type 1 Pregnancy Early Motherhood |
Other: web-based support |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web) |
- Diabetes Empowerment Scale (SWE-DES-10) [ Time Frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion ] [ Designated as safety issue: No ]
- Well-Being Questionnaire (W-BQ12) [ Time Frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Web-based support
The subjects will get access to a website where they can store blood glucose levels, read specialized information concerning pregnancy and early motherhood, and access a discussion forum for peer support.
|
Other: web-based support |
| No Intervention: Usual care |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pregnant women and new mothers with type 1 diabetes
Exclusion Criteria:
- women not understanding Swedish
Contacts and Locations| Contact: Marie Berg, Professor | marie.berg@gu.se |
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden | |
| Contact: Karolina Lindén, Master karolina.linden@gu.se | |
More Information
No publications provided
| Responsible Party: | Göteborg University |
| ClinicalTrials.gov Identifier: | NCT01565824 History of Changes |
| Other Study ID Numbers: | MODIAB-web |
| Study First Received: | March 27, 2012 |
| Last Updated: | April 24, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013