An individual motivational intervention program to promote and maintain self-care behaviour in Diabetes - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Diabetes

Intervention / Treatment

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

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.

Study Type

Interventional

Enrollment (Actual)

349

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- Funen
  - Odense, Funen, Denmark, 5000
    - Department of Endocrinology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c Time Frame: one year	one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

Principal Investigator: Jan Erik Henriksen, MD, Ph.D, Institute of Clinical Research, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria