Clinical trial NCT01507116: Diabetes Attitudes Wishes and Needs
Official title: Diabetes Attitudes Wishes and Needs (DAWN) 2 Study: A Multinational, Multi-stakeholder Survey Study of Psychosocial Issues in Diabetes and Patient-centred Diabetes Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Relatives to/Carers of Patients
Healthcare Professionals
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 8985
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-reported health and Quality of Life (QoL) (measured by the study questionnaire)
timeFrame: Day 1
Secondary outcomes:
measure: Psychological well-being of people with diabetes and family members measured by the study questionnaire
timeFrame: Day 1
measure: Diabetes distress of people with diabetes and family members measured by the study questionnaire
timeFrame: Day 1
measure: Self-reported self-management of people with diabetes measured by the study questionnaire
timeFrame: Day 1
measure: Family support behaviours reported by people with diabetes and family members measured by the study questionnaire
timeFrame: Day 1
measure: Patient-centred diabetes care reported by people with diabetes and health care professionals measured by the study questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Algiers
country: Algeria
facility: Novo Nordisk Investigational Site
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Copenhagen S
country: Denmark
facility: Novo Nordisk Investigational Site
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Alphen a/d Rijn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.