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STigma and Its Impact on Glucose Control aMong Youth With diAbetes, a Canada-Wide Study (STIGMA)

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: NCT02796248
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Center

Brief Summary:

Stigma related to chronic disease is rejection or judgement or exclusion by others that is related to the chronic disease itself and is unwarranted. We are trying to figure out what proportion of young people with type 1 diabetes experience stigma in Canada. By young people, we mean teenagers and young adults; specifically, people who are between 14 and 25 years of age. This is a challenging period in life when identities are developed and peer opinions are felt to be particularly important. Experiencing stigma in this life period may be especially hurtful and may have bad effects on taking care of type 1 diabetes. This may lead to important medical problems like dangerously low or high blood sugar values. By understanding how common stigma is, we can figure out the need for programs and strategies to deal with it.

We will ask young people with type 1 diabetes to help us study this problem by completing an online survey. We will 'advertise' our study through type 1 diabetes clinics, websites, and social media. People who are eligible and interested will click on an internet link and be directed to the survey. Staff at clinics in Montreal, Calgary, and Vancouver will also draw their attention to the posters and/or provide small flyers with the internet link for the study.

Participants will be asked about their general sense of well-being, their habits and behaviours, and their blood sugar control, including frequency of both lows and highs. They will also be asked if they are willing to mail in a small blood sample. If yes, they will receive a kit with a small lancing device and instructions on how to clean their finger tip, prick it, and express a few drops of blood into a small container. They will then mail this back to us in a postage-paid envelope. We will use this to measure their hemoglobin A1c, an overall measure of blood sugar control.

We will use this information to (1) calculate the proportion of young people with type 1 diabetes who experience stigma; (2) figure out what factors and behaviours might predict or signal the experience of stigma; (3) see if there is a link between stigma and A1c control and/or frequent lows by report; (4) explore challenges and solutions voiced through the open-ended questions.


Condition or disease Intervention/treatment
Type 1 Diabetes Social Stigma Other: cross-sectional survey

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: STigma and Its Impact on Glucose Control aMong Youth With diAbetes, a Canada-Wide Study
Study Start Date : May 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1


Intervention Details:
  • Other: cross-sectional survey
    This is an observation study. Participants will complete a survey at one occasion. Participants are also invited to do a A1c mail-in capillary test.


Primary Outcome Measures :
  1. Presence of stigma [ Time Frame: At survey completion ]
    Will be ascertained through a series of questions


Secondary Outcome Measures :
  1. A1c [ Time Frame: At survey completion ]
    As noted, participants will be provided with a lancet and small container in which to express a couple of drops of blood. While this may cause some discomfort, given that all participants have type 1 diabetes, they are familiar with this procedure and express blood in this fashion regularly.

  2. Hypoglycemia frequency [ Time Frame: At survey completion; recall period varies from past week to past year ]
    Questions

  3. Diabetes-related self-efficicay [ Time Frame: At survey completion ]
    Questions based on Iannotti et al,. Developmental and Behavioral Pediatrics, 2006

  4. Diabetes-related distress [ Time Frame: At survey completion ]
    Questions based on Polonsky et al, Diabetes Care, 1995

  5. Quality of life [ Time Frame: At survey completion; recall period is past month ]
    Questions based on Varni et al. Diabetes Care 2003

  6. Well-Being Index [ Time Frame: At survey completion; recall period is past two months ]
    Questions from World Health Organization WHO (Five) Well-Being Index



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents and young adults (14-24 years of age) with type 1 diabetes living in Canada
Criteria

Inclusion Criteria:

  • type 1 diabetes
  • Canadian citizen
  • Aged between 14 and 24 years

Exclusion Criteria:

  • other forms of diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796248


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Center
Canadian Diabetes Association
Investigators
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Principal Investigator: Kaberi Dasgupta, MD McGill University Health Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaberi Dasgupta, MD, MSc, FRCP (C), Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02796248     History of Changes
Other Study ID Numbers: ST-1-16-5046-DK
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Center:
type 1 diabetes
glucose control
stigma
youth

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