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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2021-02-10

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.

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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.

Conditions

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Type 2 Diabetes Mellitus Primary Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pragmatic blinded parallel group superiority cluster randomized controlled trial. Clusters are PCPs (general practitioners, medical practitioners and internists working as general practitioners).

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention group

In the intervention group the routine health check is expanded by usage of a non-invasive diabetes risk score.

Group Type EXPERIMENTAL

external validated risk prediction model

Intervention Type OTHER

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.

Control group

In the control group the routine health check is conducted.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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external validated risk prediction model

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.

Intervention Type OTHER

Other Intervention Names

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The German Diabetes Risk Score

Eligibility Criteria

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Inclusion Criteria

* 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

* appointment for the routine health check
* insured in statutory health insurance
* age \> 35 years
* Body Mass Index (BMI) of ≥ 27 kg/m2

Exclusion Criteria

* treat exclusively patients with private insurance
* treat exclusively diabetes patients in a specialized medical practice

* 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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes