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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565824
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Swedish Diabetes Association
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date March 4, 2019
Study Start Date  ICMJE November 2011
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
  • Diabetes Empowerment Scale (SWE-DES-10)
  • Well-Being Questionnaire (W-BQ12)
Change History Complete list of historical versions of study NCT01565824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)
Official Title  ICMJE Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes Type 1
  • Pregnancy
  • Early Motherhood
Intervention  ICMJE Other: web-based support
Study Arms  ICMJE
  • 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.
    Intervention: Other: web-based support
  • No Intervention: Usual care
Publications * Adolfsson A, Linden K, Sparud-Lundin C, Larsson PG, Berg M. A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial. Trials. 2014 Dec 29;15:513. doi: 10.1186/1745-6215-15-513.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2017)
174
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
160
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565824
Other Study ID Numbers  ICMJE MODIAB-web
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE
  • Swedish Diabetes Association
  • Vastra Gotaland Region
Investigators  ICMJE Not Provided
PRS Account Göteborg University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP