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

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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Primary Prevention
• Intervention / Treatment: Other: external validated risk prediction model

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.

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • German Diabetes Center, Institute for Biometrics and Epidemiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.; Other Names: The German Diabetes Risk Score
No Intervention: Control group; In the control group the routine health check is conducted.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on participant's individual diabetes risk.	Self-reported outcome. Individual diabetes risk will be derived from the diabetes risk score in the intervention group at baseline, which is a validated questionnaire. In the follow-up questionnaires at 6 and 12 months, the questions of the diabetes risk score are included in the questionnaire of both groups.	at baseline, 6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: German Diabetes Center
• Collaborators: German Institute of Human Nutrition; Association of Statutory Health Insurance Physicians North Rhine
• Investigators: Principal Investigator: Wolfgang Rathmann, Prof., German Diabetes Center

Publications and helpful links

General Publications

• Dhippayom T, Chaiyakunapruk N, Krass I. How diabetes risk assessment tools are implemented in practice: a systematic review. Diabetes Res Clin Pract. 2014 Jun;104(3):329-42. doi: 10.1016/j.diabres.2014.01.008. Epub 2014 Jan 15.
• Noble D, Mathur R, Dent T, Meads C, Greenhalgh T. Risk models and scores for type 2 diabetes: systematic review. BMJ. 2011 Nov 28;343:d7163. doi: 10.1136/bmj.d7163.
• Godino JG, van Sluijs EM, Marteau TM, Sutton S, Sharp SJ, Griffin SJ. Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial. PLoS Med. 2016 Nov 29;13(11):e1002185. doi: 10.1371/journal.pmed.1002185. eCollection 2016 Nov.
• Muller-Riemenschneider F, Holmberg C, Rieckmann N, Kliems H, Rufer V, Muller-Nordhorn J, Willich SN. Barriers to routine risk-score use for healthy primary care patients: survey and qualitative study. Arch Intern Med. 2010 Apr 26;170(8):719-24. doi: 10.1001/archinternmed.2010.66.
• Seidel-Jacobs E, Kohl F, Tamayo M, Rosenbauer J, Schulze MB, Kuss O, Rathmann W. Impact of applying a diabetes risk score in primary care on change in physical activity: a pragmatic cluster randomised trial. Acta Diabetol. 2022 Aug;59(8):1031-1040. doi: 10.1007/s00592-022-01895-y. Epub 2022 May 13.
• Jacobs E, Tamayo M, Rosenbauer J, Schulze MB, Kuss O, Rathmann W. Protocol of a cluster randomized trial to investigate the impact of a type 2 diabetes risk prediction model on change in physical activity in primary care. BMC Endocr Disord. 2018 Oct 16;18(1):72. doi: 10.1186/s12902-018-0299-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; prevention; risk score; behaviour
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DRT-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Twelve months after data publication, de-identified data can be provided to other researchers upon request.
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: Universities and other non-profit organizations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No