Diabetes Attitudes Wishes and Needs (DAWN2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507116
First received: January 4, 2012
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Relatives to/Carers of Patients
Healthcare Professionals
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Self-reported health and Quality of Life (QoL) (measured by the study questionnaire) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological well-being of people with diabetes and family members measured by the study questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Diabetes distress of people with diabetes and family members measured by the study questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Self-reported self-management of people with diabetes measured by the study questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Family support behaviours reported by people with diabetes and family members measured by the study questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Patient-centred diabetes care reported by people with diabetes and health care professionals measured by the study questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 8985
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
People with Diabetes Other: No treatment given
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 Members Other: No treatment given
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.
Healthcare Professionals Other: No treatment given
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  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: NCT01507116

  Show 17 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Søren Skovlund Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507116     History of Changes
Other Study ID Numbers: INS-3966, U1111-1123-7509
Study First Received: January 4, 2012
Last Updated: April 17, 2013
Health Authority: Algeria: Ministry of Health
Canada: Public Health Agency of Canada
China: Food and Drug Administration
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
India: Ministry of Health and Family Wellfare
Italy: AIFA, National Medicines Agency
Japan: Ministry of Health, Labour and Welfare (MHLW)
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate
Poland: Ministry of Health and Social Security
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines and Health Care Products
Turkey: Ministry of Health Drug and Pharmaceutical Department
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014