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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 12, 2014
Last verified: August 2014
  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 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.


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: March 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:

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

Exclusion Criteria:

  • women who are illiterate, or do not read and speak Swedish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565824

Contacts
Contact: Marie Berg, Professor marie.berg@gu.se
Contact: Carina Sparud-Lundin, PhD, Ass Prof. carina.s-lundin@fhs.gu.se

Locations
Sweden
Sahlgrenska Academy, Institute of Health Care Sciences Recruiting
Gothenburg, Sweden
Contact: Marie Berg, Professor, PhD       marie.berg@gu.se   
Contact: Carina Sparud-Lundin, PhD, Ass professor       carina.s-lundin@fhs.gu.se   
Principal Investigator: Marie Berg, PhD, Professor         
Sponsors and Collaborators
Göteborg University
Swedish Diabetes Association
Vastra Gotaland Region
  More Information

Additional 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: August 12, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014