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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00555854
First received: November 8, 2007
Last updated: February 23, 2011
Last verified: May 2008
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: An individual motivational intervention program to promote and maintain self-care behaviour

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Can a Behavioural Modifying Intervention Increase the Self-care and the Effect of the Diabetes Treatment in Chronically Ill Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • HbA1c [ Time Frame: one year ]

Secondary Outcome Measures:
  • Lipids profile ,blood pressure, waist, BMI and medication Questionnaire: PAID PCD HCCQ TSRQ Health Care Behavioural a [ Time Frame: one year ]

Enrollment: 349
Study Start Date: December 2005
Study Completion Date: November 2010
Intervention Details:
    Behavioral: An individual motivational intervention program to promote and maintain self-care behaviour
    5 individual interviews in an one year period
Detailed Description:

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; and identify factors shaping outcomes in the areas reviewed.

The hypothesis is that a motivational intervention program based on cognitive-behavioural strategies increases patient's belief in their own capability to succeed in their diabetes care and will lead to increased self-care behaviour changes in relation to diabetes.

Materials and Methods:

A randomized controlled trial with 400 patients with diabetes is carried out at an endocrinology unit in a Danish University Hospital. The sample size was determined by a power calculation based on a standard deviation of 1.15 in the HbA1c-value and a 5% two-sided significance level. The power is set to 90 %. Assessments are made at baseline, follow-up 1 year and follow-up 2 year. Statistical analysis will be used to compare end points between the two groups.

Focus group interviews with 15 patients from the interventions group are conducted. In order to investigate the participants lived experience of diabetes they are asked to talk about their experience of their daily life with diabetes, self-care activities and diabetes treatment. Data will be analyzed using a phenomenological approach.

To asses the effect of non-pharmacological interventions from previous randomised controlled trials a meta-analytic review is carried out. 40 studies are included in the analysis that had met the following inclusions criteria: 1) randomized controlled trials; 2) published in an English or Nordic language; 3) participants were adults with type 2 diabetes; 4) tested the effect of self-care behaviour interventions; 5) reported measures and statistical data on the effect of the intervention on diabetic specific parameters; and 6) information about means and standard deviations available to calculate effect sizes. The following databases were searched: Medline, PubMed, Embase, CINAHL, PsycInfo including PsychLIT, Cochrane Library and SveMed+. The effect sizes in the included studies will be pooled by use of a random-effects model because we expect heterogeneity between studies.

The perspective of the project is to increase the knowledge about non-pharmacological diabetes treatment to increase quality of life and the effect of survival for diabetes patients.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe illness
  • Cognitive dysfunction
  • Not able to speak or read Danish
  • Pregnancy
  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: NCT00555854

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Jan Erik Henriksen, MD, Ph.D Institute of Clinical Research, University of Southern Denmark
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00555854     History of Changes
Other Study ID Numbers: 028, n
Study First Received: November 8, 2007
Last Updated: February 23, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Motivational interviewing,
Multidisciplinary
Life style changes
Prevention
Compliance
Self Care
Behaviour

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014