Diabetes Attitudes Wishes and Needs (DAWN2)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Self-reported health and Quality of Life (QoL) (measured by the study questionnaire) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- 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 |
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).
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
Hide Study Locations| United States, New Jersey | |
| Novo Nordisk Clinical Trial Call Center | |
| Princeton, New Jersey, United States, 08540 | |
| Algeria | |
| Algiers, Algeria, 16035 | |
| Canada | |
| Mississauga, Canada, L4W 4XI | |
| China, Beijing | |
| Beijing, Beijing, China, 100004 | |
| Denmark | |
| Copenhagen S, Denmark, 2300 | |
| France | |
| Paris La défense cedex, France, 92932 | |
| Germany | |
| Mainz, Germany, 55127 | |
| India | |
| Bangalore, India, 560001 | |
| Italy | |
| Rome, Italy, 00144 | |
| Japan | |
| Tokyo, Japan, 103 | |
| Mexico | |
| Mexico City, Mexico | |
| Netherlands | |
| Alphen a/d Rijn, Netherlands | |
| Poland | |
| Warszawa, Poland, PL-02-274 | |
| Russian Federation | |
| Moscow, Russian Federation, 119330 | |
| Spain | |
| Madrid, Spain, 28033 | |
| Turkey | |
| Istanbul, Turkey, 34335 | |
| United Kingdom | |
| Crawley, United Kingdom, RH11 9RT | |
| Study Director: | Søren Skovlund | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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 May 19, 2013