I-care: Stimulating Self-management in Patients With Type 2-diabetes
Condition: Diabetes Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overall objective of this pilot study is to develop a cost-effective treatment
      methodology delivered outside of traditional clinical setting, and based on modern technology
      for patients with diabetes type 2 also suffering from obesity. This study will investigate
      the feasibility of web based counselling and situational feedback through mobile supervising.
      The intention is to treat 10-15 patients. All participants will receive standard treatment
      delivered by their general practitioners. In addition the participants will fill in and send
      diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the
      next two months period. The diary's schedule will be an evaluation of the day activities
      related to meals and food, medication management as well as the performed physical
      activities. The diary's schedule will also include blood glucose sample, and plans for the
      next day especially regarding physical activity. The participants will be able to view their
      own registrations on a web page. Daily/weekly situational feedback will be given to the
      participants within a cognitive behavioural framework to stimulate self-management. The
      primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of
      lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as
      self-management of medication. In addition, the interventions effectiveness will examine
      mental health outcomes such as emotional distress and health-related quality of life.
    

Detailed description: 
      Diabetes and overweight have become a world health epidemic. The number of people suffering
      of these diseases is increasing due to population growth, aging, urbanization, and increasing
      prevalence of obesity and physical inactivity. The costs of diabetes affect health services,
      national productivity as well as individuals and families. Hospital in-patient costs for the
      treatment of complications are the largest single contributor to direct healthcare costs.
      Many of these complications and, therefore, their costs, are preventable. Intensive therapy,
      directed at the control of blood glucose, blood pressure etc, has been shown to be
      cost-effective in that, although initial costs are increased, it decreases longer term costs
      as a result of delayed or prevented complications . Diabetes self-management education is a
      multi-faceted process involving much more than helping people with diabetes to monitor their
      blood glucose, or take their medication as prescribed. Diabetes education must be an ongoing
      process rather than a one-time event because a person's health status and need for support
      change over time.
    

Intervention name(s): Cognitive behavior therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): All patients will receive standard care (reassurance, education, physiotherapy, and necessary medication). Complementary to this standard care, the participants will be required to closely monitor their blood glucose levels, weight, eating behavior and daily activities, and to relay this information to the nurse specialist trained in treating somatic patients with CBT. The nurse will then suggest appropriate treatment decisions, the patients will receive situational feedback based on the electronic diary during 3 months (daily during 4 weeks intensive treatment and weekly during 2 months as a complement).
Other intervention name(s): Life style counselling; Internet based counselling; Situational feedback
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes; obesity; behavior therapy; self management