- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01507116
Diabetes Attitudes Wishes and Needs (DAWN2)
January 18, 2017 updated by: Novo Nordisk A/S
Diabetes Attitudes Wishes and Needs (DAWN) 2 Study: A Multinational, Multi-stakeholder Survey Study of Psychosocial Issues in Diabetes and Patient-centred Diabetes Care
The study is conducted in Africa, Asia, Europe, Japan, North America and South America.
The multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
8985
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Algiers, Algeria, 16035
- Novo Nordisk Investigational Site
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Mississauga, Canada, L4W 4XI
- Novo Nordisk Investigational Site
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Beijing
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Beijing, Beijing, China, 100004
- Novo Nordisk Investigational Site
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Copenhagen S, Denmark, 2300
- Novo Nordisk Investigational Site
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Paris La défense cedex, France, 92932
- Novo Nordisk Investigational Site
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Mainz, Germany, 55127
- Novo Nordisk Investigational Site
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Bangalore, India, 560001
- Novo Nordisk Investigational Site
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Rome, Italy, 00144
- Novo Nordisk Investigational Site
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Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
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Mexico City, Mexico
- Novo Nordisk Investigational Site
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Alphen a/d Rijn, Netherlands
- Novo Nordisk Investigational Site
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Warszawa, Poland, PL-02-274
- Novo Nordisk Investigational Site
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Moscow, Russian Federation, 119330
- Novo Nordisk Investigational Site
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Madrid, Spain, 28033
- Novo Nordisk Investigational Site
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Istanbul, Turkey, 34335
- Novo Nordisk Investigational Site
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Crawley, United Kingdom, RH11 9RT
- Novo Nordisk Investigational Site
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New Jersey
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Princeton, New Jersey, United States, 08540
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The total core study population is intended to comprise 9540 people with diabetes, 2160 family members and 5040 healthcare professionals across the 18 countries participating in DAWN 2. The study population will be invited to participate by either web based or telephone recruitment, or if absolutely needed and deemed appropriate, physician recruitment (i.e.
patients recruited by physicians will telephone call centres managed by the local survey research agency and will be screened by telephone).
Description
Inclusion Criteria:
- Adults aged at least 18 years with diabetes (type 1 or type 2: not only during pregnancy)
- Adults aged at least 18 years involved in the daily care of an adult (18 years or older) with diabetes (type 1 or type 2)
- General practitioners who personally treat at least 5 adults (18 years or older) with diabetes per month and initiate oral medication
- Diabetes specialists (endocrinologists/diabetologists) who personally treat at least 50 adults (18 years or older) with diabetes per month and prescribe oral medication, insulin or other injectable diabetes medications
- Diabetes educators (diabetes nurses/dieticians/other non-physician healthcare professionals) providing care for at least 5 adults (18 years or older) with diabetes per month
- Participants must have access to the internet, either at home or at a location convenient to them, or be able to attend a face-to-face or telephone interview, to participate in the survey
- Provision of informed consent before the start of any study-related activities
Exclusion Criteria:
- Individuals aged below 18 years and/or diagnosed with diabetes less than 12 months ago
- Inability to understand and comply with written and verbal instructions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthcare Professionals
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Three separate survey questionnaires, one for each of the three diabetes groups.
Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions and rating scales.
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People with Diabetes
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Three separate survey questionnaires, one for each of the three diabetes groups.
Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions and rating scales.
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Family Members
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Three separate survey questionnaires, one for each of the three diabetes groups.
Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions and rating scales.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Self-reported health and Quality of Life (QoL) (measured by the study questionnaire)
Time Frame: Day 1
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Psychological well-being of people with diabetes and family members measured by the study questionnaire
Time Frame: Day 1
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Day 1
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Diabetes distress of people with diabetes and family members measured by the study questionnaire
Time Frame: Day 1
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Day 1
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Self-reported self-management of people with diabetes measured by the study questionnaire
Time Frame: Day 1
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Day 1
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Family support behaviours reported by people with diabetes and family members measured by the study questionnaire
Time Frame: Day 1
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Day 1
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Patient-centred diabetes care reported by people with diabetes and health care professionals measured by the study questionnaire
Time Frame: Day 1
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Peyrot M, Burns KK, Davies M, Forbes A, Hermanns N, Holt R, Kalra S, Nicolucci A, Pouwer F, Wens J, Willaing I, Skovlund SE. Diabetes Attitudes Wishes and Needs 2 (DAWN2): a multinational, multi-stakeholder study of psychosocial issues in diabetes and person-centred diabetes care. Diabetes Res Clin Pract. 2013 Feb;99(2):174-84. doi: 10.1016/j.diabres.2012.11.016. Epub 2012 Dec 27.
- Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes. Diabet Med. 2013 Jul;30(7):767-77. doi: 10.1111/dme.12245. Erratum In: Diabet Med. 2013 Oct;30(10):1266.
- Kovacs Burns K, Nicolucci A, Holt RI, Willaing I, Hermanns N, Kalra S, Wens J, Pouwer F, Skovlund SE, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking indicators for family members living with people with diabetes. Diabet Med. 2013 Jul;30(7):778-88. doi: 10.1111/dme.12239.
- Holt RI, Nicolucci A, Kovacs Burns K, Escalante M, Forbes A, Hermanns N, Kalra S, Massi-Benedetti M, Mayorov A, Menendez-Torre E, Munro N, Skovlund SE, Tarkun I, Wens J, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national comparisons on barriers and resources for optimal care--healthcare professional perspective. Diabet Med. 2013 Jul;30(7):789-98. doi: 10.1111/dme.12242.
- Funnell M. Beyond the data: moving towards a new DAWN in diabetes. Diabet Med. 2013 Jul;30(7):765-6. doi: 10.1111/dme.12244. No abstract available.
- Peyrot M, Egede LE, Campos C, Cannon AJ, Funnell MM, Hsu WC, Ruggiero L, Siminerio LM, Stuckey HL. Ethnic differences in psychological outcomes among people with diabetes: USA results from the second Diabetes Attitudes, Wishes, and Needs (DAWN2) study. Curr Med Res Opin. 2014 Nov;30(11):2241-54. doi: 10.1185/03007995.2014.947023. Epub 2014 Aug 18.
- Peyrot M, Egede LE, Funnell MM, Hsu WC, Ruggiero L, Siminerio LM, Stuckey HL. US ethnic group differences in self-management in the 2nd diabetes attitudes, wishes and needs (DAWN2) study. J Diabetes Complications. 2018 Jun;32(6):586-592. doi: 10.1016/j.jdiacomp.2018.03.002. Epub 2018 Mar 8.
- Nefs G, Pouwer F. The role of hypoglycemia in the burden of living with diabetes among adults with diabetes and family members: results from the DAWN2 study in The Netherlands. BMC Public Health. 2018 Jan 18;18(1):156. doi: 10.1186/s12889-018-5064-y.
- Barnard KD, Holt RI, Dyson PA, Cummings MH, Kanumilli N, O'Neill S, Hall G. Could the Discrepancy in Perceived Emotional Care Received and Provided Be a Barrier to Active Diabetes Self-management? Insights From the Second Diabetes Attitudes, Wishes and Needs (DAWN2) Study. Diabetes Care. 2016 Feb;39(2):e20-1. doi: 10.2337/dc15-0674. Epub 2015 Dec 30. No abstract available.
- Peyrot M, Egede LE, Funnell MM, Hsu WC, Ruggiero L, Siminerio LM, Stuckey HL. Ethnic differences in family member diabetes involvement and psychological outcomes: results from the second Diabetes Attitudes, Wishes and Needs (DAWN2) study in the USA. Curr Med Res Opin. 2015;31(7):1297-307. doi: 10.1185/03007995.2015.1043251. Epub 2015 May 20.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 4, 2012
First Submitted That Met QC Criteria
January 5, 2012
First Posted (Estimate)
January 10, 2012
Study Record Updates
Last Update Posted (Estimate)
January 19, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INS-3966
- U1111-1123-7509 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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