The Effectiveness of Diabetes Self-Management Education Program Based on Behavioural Change Theory
Condition: Health Behavior; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study, researchers will test the effectiveness of a self-management education
      programme, on self-management behaviours of patients with type two diabetes. Up to 230
      consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230
      participants will be randomised to one of two groups. Group 1 ( 115 patients) have received
      the intervention, which consisted of an introductory session of tailored, face-to-face
      education and advice, followed by educational materials to take away, and regular telephone
      support at a regularity specified by the patient, over a three-month period. This
      intervention is based on behavioural change theory called the
      Information-Motivational-Behavioural skills model. Group 2 (115 patients) have received usual
      clinical care with no additional intervention. Researchers have assessed the effectiveness of
      the intervention by measuring self-care strategies (dietary habits, physical activity and
      managing diabetes medications), diabetes control (HbA1c), quality of life and Diabetes
      Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points: before the
      intervention, at 3 months and at 6 months.
    

Detailed description: 
      Background: Type 2 Diabetes (T2DM) is prevalent, costly to healthcare services and associated
      with significant mortality; over 1.5 million deaths occur directly by diabetes in low and
      middle-income countries (WHO,2014) and diabetes is predicted to be the seventh leading cause
      of death by 2030. Ajlouni et al (2008) estimated that approximately one million people in
      Jordan have been diagnosed with type 2 diabetes; a figure that is increasing. More than half
      a million Jordanians have an uncontrolled level of Glycosylated Hemoglobin (HbA1c >7.5%) due
      to factors such as sedentary lifestyle and poor medication management. To prevent diabetes
      microvascular and macro vascular complications, increased efforts and attention need to be
      directed towards improving glycaemic levels and improving metabolic outcomes through
      appropriate glycaemic management. Intensive diabetes management by anti-hyperglycaemic
      medications alone may improve metabolic outcomes, but may also lead to side effects for
      patients such as hypoglycaemia and weight gain. Patients with diabetes are strongly
      recommended to engage in self-management over their glucose levels and this may be best
      achieved through educating patients in self-management of diabetes.

      Didactic interventions have shown to improve metabolic outcomes, although benefits last less
      than six months and are not sustained in the long term. Educational programs need to target
      psychological factors such as patient's confidence, to ensure self-management strategies are
      sustained in the long term. Barriers in diabetes self-management behaviours map on to the
      Information-Motivation-Behavioural skills (IMB) Model of behavioural change. The model was
      critically constructed based on analysing previous interventions and addressing limitations
      of the theories that have been used among clients with HIV risk. Chang et al (2014)
      systematically reviewed the IMB model-based behavioural interventions and found that effects
      of IMB model persisted up to 12 months in studies followed up patients for 12 months.

      Aim: To examine the effects of IMB Model-based Diabetes Self-Management Educational (DSME)
      intervention on three self-management activities: patients' eating habits, physical activity
      and medications management, in patients who attend an outpatients diabetes clinics at Jordan
      University Hospital and Prince Hamzeh Hospital in Jordan. The hypothesis to be tested is that
      the IMB educational program will improve participants' behavioural outcomes in self-care at 6
      months compared with control participants.

      Research protocol and methods: A two group trial with randomised allocation of 230
      participants on 1:1 average for both groups. Intervention group will receive the educational
      intervention. Control group will receive usual clinical care and referral to diabetes
      educational consultation if required. This intervention is an individualised DSME program
      based on Information-Motivation-Behavioural (IMB) skills theory. IMB behavioural change
      theory assumption proposes that health-related behaviour information, motivation and
      behavioural skills are primary determinants of promoting health behaviour. The intervention
      will be based on a validated DSME toolkit and will be delivered using motivational
      interviewing techniques through a two face-to-face session and follow-up phone calls at
      patients preferred frequency for a period of 3 months.

      Data collection will occur at 3 time points; baseline, 3 months and 6 months. Measures will
      include self-management knowledge, motivation, behavioural skills, diabetes outcomes (HbA1c),
      blood pressure and weight. At 3 months, some participants in the intervention group will be
      selected using purposive sampling, to participate in a process evaluation interview.

      Measurable end point/statistical power of the study: Primary outcome is diabetes self-care
      activities measured at 6 months using the Summary of Diabetes Self-Care Activities Scale
      (SDSCA) questionnaire. Statistical power of 0.8 has been used to calculate study sample.
    

Intervention name(s): Diabetes Self-Management Education
Intervention type(s): Behavioral
Intervention description(s): This study will implement an individualized DSME program based on Information-Motivation-Behavioral (IMB) skills theory. IMB behavioral change theory assumption proposes that health-related behavior information, motivation and behavioural skills are primary determinants of promoting health behavior.
Researcher will use a previously validated educational toolkit (PRIDE) and will be delivered using motivational interviewing techniques through several sessions for each participant. Two face-to-face sessions (one at the beginning and one at the end of the 3 month period) and one phone call per week or per fortnight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Self-Management Education; Behavioural change theory; IMB model; Diabetes Type 2