Self-care Behaviour Treatment in Patients With Diabetes - a Randomised Controlled Trial

NCT00555854 | Completed

• 2 other identifiers: 028n
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is a common condition associated with increased morbidity and mortality. Non-pharmacological intervention strategies focusing on factors to improve self-management skills are considered an important part of the treatment in individuals with diabetes. Because of the increasing incidence in diabetes with costs (both physical, psychological and financial) for both patients and society it is important to investigate interventions that successfully promote self-care behaviour in patient with diabetes. Further research is needed to develop interventions effective in maintaining long-term glycemic control. The aim of this project is to study the long-term effect of a motivational intervention program with an individual approach based on cognitive-behavioural strategies in chronically ill patients with diabetes. The effect will be evaluated on both physiological and psychosocial parameters including patient's experienced self-care competence. The study will also provide an overview of what kind of non-pharmacological interventions that have been applied in relation to the treatment of type 2 diabetes and assess the effect of the various non-pharmacological interventions in randomised controlled trials.

Conditions

Diabetes

Keywords

Motivational interviewing,; Multidisciplinary; Life style changes; Prevention; Compliance; Self Care; Behaviour

Outcome Measures

Primary Outcomes (1)

• HbA1c

  one year

Secondary Outcomes (1)

• Lipids profile ,blood pressure, waist, BMI and medication Questionnaire: PAID PCD HCCQ TSRQ Health Care Behavioural a

  one year

Interventions

An individual motivational intervention program to promote and maintain self-care behaviour BEHAVIORAL

5 individual interviews in an one year period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and female age above 18 years
• Diagnosed with diabetes completed and participated in a diabetes school program

You may not qualify if:

• Severe illness
• Cognitive dysfunction
• Not able to speak or read Danish
• Pregnancy

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

• Rosenbek Minet LK, Wagner L, Lonvig EM, Hjelmborg J, Henriksen JE. The effect of motivational interviewing on glycaemic control and perceived competence of diabetes self-management in patients with type 1 and type 2 diabetes mellitus after attending a group education programme: a randomised controlled trial. Diabetologia. 2011 Jul;54(7):1620-9. doi: 10.1007/s00125-011-2120-x. Epub 2011 Apr 1.

  PMID: 21455729 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Patient Compliance; Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Jan Erik Henriksen, MD, Ph.D

  Institute of Clinical Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: December 1, 2005
• Study Completion: November 1, 2010
• Last Updated: February 24, 2011

Record last verified: 2008-05

Locations

DK (1)