The Impact of a Diabetes Risk Prediction Model in Primary Care.
- Conditions
- Type 2 Diabetes MellitusPrimary Prevention
- Interventions
- Other: external validated risk prediction model
- Registration Number
- NCT03234322
- Lead Sponsor
- German Diabetes Center
- Brief Summary
Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and patient's behavior, perceived risk of persons, shared-decision making and particularly on patient´s health. The aim of this study is to investigate the impact of a non-invasive diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.
- Detailed Description
Diabetes risk scores are predictive models to estimate the probability for an individual to develop diabetes within a defined time period. In the last years, many diabetes risk prediction models were developed worldwide. It has been proposed that using diabetes risk scores as first step of diabetes screening is more practical than blood glucose tests as the latter are time consuming and costly. Given the rapid development of diabetes risk scores and a simultaneous reluctance of primary care physicians (PCPs) to implement diabetes risk scores in everyday practice, there is an urgent need to expand our knowledge of the impact of diabetes risk scores in the primary health care setting. Thus, the aim of the study is to investigate the impact of a non-invasive risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group external validated risk prediction model In the intervention group the routine health check is expanded by usage of a non-invasive diabetes risk score.
- Primary Outcome Measures
Name Time Method Difference of participant's physical activity at twelve months after the routine health check between the groups. at baseline, 6 and 12 months follow-up Self-reported outcome, international validated questionnaire Physical Activity Questionnaire Short Last 7 Days Format (IPAQ-SF), which has been shown to be a reliable and valid tool to obtain comparable estimates of physical activity.
- Secondary Outcome Measures
Name Time Method Change in participant's quality of life. at baseline, 6 and 12 months follow-up Self-reported outcome, question has been derived from previous studies. We will assess the change of quality of life between the groups.
Improvement of shared decision making, assessed by participants. at baseline Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups.
Improvement of shared decision making, assessed by PCPs. at baseline Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups.
Change in Body-Mass-Index (BMI) at baseline, 6 and 12 months follow-up At baseline, weight and height is objectively measured by the PCP, in the follow-up weight will be self-reported. We will analyse group differences in change of BMI at 6 and 12 months follow-up.
Change in participant's level of depression and anxiety. at baseline, 6 and 12 months follow-up Self-reported outcomes, depression and anxiety will be assessed with a validated questionnaire, the Hospital Anxiety and Depression Scale (HADS-D). We will assess the change of depression and anxiety between the groups.
Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice. at baseline, and up to one year after the PCP entered the study Self-reported outcome, differences between the groups will be analyzed. Questions are derived from previous studies.
Improvement in the counseling process assessed by PCPs. at baseline and up to one year after the PCP entered the study Self-reported outcome, analyzed as difference in proportion of counseling regarding preventive strategies on balanced nutrition, body weight reduction, physical activity, and smoking secession between the groups. Questions are derived from a previous study.
Improvement in the counseling process assessed by participants. at 6 months follow-up Self-reported outcome, analyzed as difference in proportion of counseling regarding preventive strategies on balanced nutrition, body weight reduction, physical activity, and smoking secession between the groups. Questions are derived from a previous study.
Improved motivation to change lifestyle, assessed by participants. at baseline, 6 and 12 months follow-up Self-reported outcome, questions are based on the stage of change model to assess the stage of motivation according to weight reduction, physical activity, healthy diet, smoking cessation and were derived from previous studies. We will assess the difference of motivation change between the groups.
Change of participant's perceived risk of developing diabetes. at baseline, 6 and 12 months follow-up Self-reported outcome by participants, questions derived from previous studies. We will assess the change in perceived risk between the groups.
Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice. at 6 months follow-up Self-reported outcome, questions derived from previous studies.
Trial Locations
- Locations (1)
German Diabetes Center, Institute for Biometrics and Epidemiology
🇩🇪Düsseldorf, North Rhine-Westphalia, Germany