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

This study is currently recruiting participants.
Verified October 2013 by Göteborg University
Sponsor:
Collaborators:
Swedish Diabetes Association
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01565824
First received: March 27, 2012
Last updated: October 29, 2013
Last verified: October 2013
  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)

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • pregnant women and new mothers with type 1 diabetes

Exclusion Criteria:

  • women not understanding Swedish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565824

Contacts
Contact: Marie Berg, Professor marie.berg@gu.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Karolina Lindén, Master       karolina.linden@gu.se   
Sponsors and Collaborators
Göteborg University
Swedish Diabetes Association
Vastra Gotaland Region
  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: October 29, 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 April 17, 2014