NCT01507116

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,985

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
17 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 4, 2012

Last Update Submit

January 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported health and Quality of Life (QoL) (measured by the study questionnaire)

    Day 1

Secondary Outcomes (5)

  • Psychological well-being of people with diabetes and family members measured by the study questionnaire

    Day 1

  • Diabetes distress of people with diabetes and family members measured by the study questionnaire

    Day 1

  • Self-reported self-management of people with diabetes measured by the study questionnaire

    Day 1

  • Family support behaviours reported by people with diabetes and family members measured by the study questionnaire

    Day 1

  • Patient-centred diabetes care reported by people with diabetes and health care professionals measured by the study questionnaire

    Day 1

Study Arms (3)

People with Diabetes

Other: No treatment given

Family Members

Other: No treatment given

Healthcare Professionals

Other: No treatment given

Interventions

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.

Family MembersHealthcare ProfessionalsPeople with Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

Location

Novo Nordisk Investigational Site

Algiers, 16035, Algeria

Location

Novo Nordisk Investigational Site

Mississauga, L4W 4XI, Canada

Location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Location

Novo Nordisk Investigational Site

Copenhagen S, 2300, Denmark

Location

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Location

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Location

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Novo Nordisk Investigational Site

Rome, 00144, Italy

Location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Novo Nordisk Investigational Site

Mexico City, Mexico

Location

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Location

Novo Nordisk Investigational Site

Warsaw, PL-02-274, Poland

Location

Novo Nordisk Investigational Site

Moscow, 119330, Russia

Location

Novo Nordisk Investigational Site

Madrid, 28033, Spain

Location

Novo Nordisk Investigational Site

Istanbul, 34335, Turkey (Türkiye)

Location

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Location

Related Publications (10)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 10, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations