Can a Behavioural Modifying Intervention Increase the Self-care and the Effect of the Diabetes Treatment in Chronically Ill Patients With Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 349
- Locations
- 2
- Primary Endpoint
- HbA1c
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HbA1c
Time Frame: one year
Secondary Outcomes
- Lipids profile ,blood pressure, waist, BMI and medication Questionnaire: PAID PCD HCCQ TSRQ Health Care Behavioural a(one year)