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

Primary Purpose

Type 2 Diabetes Mellitus, Primary Prevention

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

external validated risk prediction model

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring prevention, risk score, behaviour, physical activity

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

German Diabetes Center, Institute for Biometrics and Epidemiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

In the control group the routine health check is conducted.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Improvement in the counseling process assessed by participants.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03234322

First Posted

July 13, 2017

Last Updated

August 9, 2021

Sponsor

German Diabetes Center

Collaborators

Association of Statutory Health Insurance Physicians North Rhine, German Institute of Human Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT03234322

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 13, 2017 (Actual)

Primary Completion Date

February 10, 2021 (Actual)

Study Completion Date

February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

German Diabetes Center

Collaborators

Association of Statutory Health Insurance Physicians North Rhine, German Institute of Human Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Primary Prevention

Keywords

prevention, risk score, behaviour, physical activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

315 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

In the control group the routine health check is conducted.

Intervention Type

Other

Intervention Name(s)

external validated risk prediction model

Other Intervention Name(s)

The German Diabetes Risk Score

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference of participant's physical activity at twelve months after the routine health check between the groups.

Description

Time Frame

at baseline, 6 and 12 months follow-up

Secondary Outcome Measure Information:

Title

Improvement in the counseling process assessed by PCPs.

Description

Time Frame

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

Title

Improvement in the counseling process assessed by participants.

Description

Time Frame

at 6 months follow-up

Title

Improvement of shared decision making, assessed by participants.

Description

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

Title

Improvement of shared decision making, assessed by PCPs.

Description

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

Title

Improved motivation to change lifestyle, assessed by participants.

Description

Time Frame

at baseline, 6 and 12 months follow-up

Title

Change in Body-Mass-Index (BMI)

Description

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.

Time Frame

at baseline, 6 and 12 months follow-up

Title

Change in participant's quality of life.

Description

Self-reported outcome, question has been derived from previous studies. We will assess the change of quality of life between the groups.

Time Frame

at baseline, 6 and 12 months follow-up

Title

Change in participant's level of depression and anxiety.

Description

Time Frame

at baseline, 6 and 12 months follow-up

Title

Change of participant's perceived risk of developing diabetes.

Description

Self-reported outcome by participants, questions derived from previous studies. We will assess the change in perceived risk between the groups.

Time Frame

at baseline, 6 and 12 months follow-up

Title

Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice.

Description

Self-reported outcome, differences between the groups will be analyzed. Questions are derived from previous studies.

Time Frame

at baseline, and up to one year after the PCP entered the study

Title

Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice.

Description

Self-reported outcome, questions derived from previous studies.

Time Frame

at 6 months follow-up

Other Pre-specified Outcome Measures:

Title

Change on participant's individual diabetes risk.

Description

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.

Time Frame

at baseline, 6 and 12 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Rathmann, Prof.

Organizational Affiliation

German Diabetes Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

German Diabetes Center, Institute for Biometrics and Epidemiology

City

Düsseldorf

State/Province

North Rhine-Westphalia

ZIP/Postal Code

40225

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

24485859

Citation

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.

Results Reference

background

PubMed Identifier

22123912

Citation

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.

Results Reference

background

PubMed Identifier

27898672

Citation

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.

Results Reference

background

PubMed Identifier

20421559

Citation

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.

Results Reference

background

PubMed Identifier

35551495

Citation

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.

Results Reference

derived

PubMed Identifier

30326888

Citation

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.

Results Reference

derived

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

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