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

German Diabetes Center315 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

315

Conditions

Type 2 Diabetes Mellitus Primary Prevention

Interventions

external validated risk prediction modelOTHER

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.

Eligibility

Sex: ALLMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

German Diabetes Center, Institute for Biometrics and Epidemiology

Düsseldorf, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: at baseline, 6 and 12 months follow-up

Secondary Outcomes

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.

Time frame: at baseline and up to one year after the PCP entered the study

Improvement in the counseling process assessed by participants.

Time frame: 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.

Time frame: 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.

Time frame: at baseline

Data from ClinicalTrials.gov

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