The Impact of a Diabetes Risk Prediction Model in Primary Care.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Cluster Randomized Trial to Investigate the Impact of a Type 2 Diabetes Risk Prediction Model on Change in Physical Activity Within Routine Health Checks in Primary Care.

Conditions
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Type 2 Diabetes Mellitus, Primary Prevention

Intervention / Treatment
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* Other: external validated risk prediction model


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for participation of medical practitioners: general practitioners, medical practitioners and internists working as general practitioners with and without further training in diabetology according to German Diabetes Association standards provide the routine health check Exclusion criteria for participation of medical practitioners: treat exclusively patients with private insurance treat exclusively diabetes patients in a specialized medical practice Inclusion criteria for participation of participants appointment for the routine health check insured in statutory health insurance age > 35 years Body Mass Index (BMI) of ≥ 27 kg/m2 Exclusion criteria for participation of participants type 1 or type 2 diabetes diagnosis or already abnormal blood glucose level (fasting glucose ≥ 126 mg/dl or 2 hours oral glucose tolerance test (oGTT) ≥ 200mg/dl or glycated hemoglobin (HbA1c) ≥6,5%) before the routine health check no sufficient German language skills to fill in the questionnaires presence of an incurable disease with a prognosis of less than one year severe mental illness or dementia severe underlying disease, which largely impairs physical activity pregnancy participation in another clinical study 30 days before study inclusion

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pragmatic blinded parallel group superiority cluster randomized controlled trial. Clusters are PCPs (general practitioners, medical practitioners and internists working as general practitioners).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>In the intervention group the routine health check is expanded by usage of a non-invasive diabetes risk score. | Other: external validated risk prediction model<br>* The risk prediction model will be integrated into a routine health check. The diabetes risk prediction model contains modifiable non-invasive risk factors and consists of eleven questions on age, height, waist circumference, hypertension, physical activity, smoking status, intake of whole-grain bread, intake of red meat, coffee consumption, and family history of diabetes (parents and siblings) to predict the five-year diabetes risk. The filled diabetes risk score will be used in the counseling interview with the PCP at the end of the health check as a practical guide to discuss individual tailored preventive strategies.<br>* Other names: The German Diabetes Risk Score;|
| No Intervention: Control group<br>In the control group the routine health check is conducted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of participant's physical activity at twelve months after the routine health check between the groups. | 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. | at baseline, 6 and 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the counseling process assessed by PCPs. | 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. | at baseline and up to one year after the PCP entered the study | 
| Improvement in the counseling process assessed by participants. | 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. | at 6 months follow-up | 
| Improvement of shared decision making, assessed by participants. | Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups. | at baseline | 
| Improvement of shared decision making, assessed by PCPs. | Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups. | at baseline | 
| Improved motivation to change lifestyle, assessed by participants. | 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. | at baseline, 6 and 12 months follow-up | 
| Change in Body-Mass-Index (BMI) | 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. | at baseline, 6 and 12 months follow-up | 
| Change in participant's quality of life. | Self-reported outcome, question has been derived from previous studies. We will assess the change of quality of life between the groups. | at baseline, 6 and 12 months follow-up | 
| Change in participant's level of depression and anxiety. | 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. | at baseline, 6 and 12 months follow-up | 
| Change of participant's perceived risk of developing diabetes. | Self-reported outcome by participants, questions derived from previous studies. We will assess the change in perceived risk between the groups. | at baseline, 6 and 12 months follow-up | 
| Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice. | Self-reported outcome, differences between the groups will be analyzed. Questions are derived from previous studies. | at baseline, and up to one year after the PCP entered the study | 
| Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice. | Self-reported outcome, questions derived from previous studies. | at 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, risk score, behaviour, physical activity