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

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ClinicalTrials.gov Identifier: NCT03234322
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : March 30, 2021
Sponsor:
Collaborators:
Association of Statutory Health Insurance Physicians North Rhine
German Institute of Human Nutrition
Information provided by (Responsible Party):
Wolfgang Rathmann, German Diabetes Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Primary Prevention Other: external validated risk prediction model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


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 Name: The German Diabetes Risk Score

No Intervention: Control group
In the control group the routine health check is conducted.



Primary Outcome Measures :
  1. Difference of participant's physical activity at twelve months after the routine health check between the groups. [ Time Frame: at baseline, 6 and 12 months follow-up ]
    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 :
  1. Improvement in the counseling process assessed by PCPs. [ Time Frame: at baseline and up to one year after the PCP entered the study ]
    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.

  2. Improvement in the counseling process assessed by participants. [ Time Frame: at 6 months follow-up ]
    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.

  3. Improvement of shared decision making, assessed by participants. [ Time Frame: at baseline ]
    Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups.

  4. Improvement of shared decision making, assessed by PCPs. [ Time Frame: at baseline ]
    Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups.

  5. Improved motivation to change lifestyle, assessed by participants. [ Time Frame: at baseline, 6 and 12 months follow-up ]
    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.

  6. Change in Body-Mass-Index (BMI) [ Time Frame: at baseline, 6 and 12 months follow-up ]
    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.

  7. Change in participant's quality of life. [ Time Frame: at baseline, 6 and 12 months follow-up ]
    Self-reported outcome, question has been derived from previous studies. We will assess the change of quality of life between the groups.

  8. Change in participant's level of depression and anxiety. [ Time Frame: at baseline, 6 and 12 months follow-up ]
    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.

  9. Change of participant's perceived risk of developing diabetes. [ Time Frame: at baseline, 6 and 12 months follow-up ]
    Self-reported outcome by participants, questions derived from previous studies. We will assess the change in perceived risk between the groups.

  10. Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice. [ Time Frame: at baseline, and up to one year after the PCP entered the study ]
    Self-reported outcome, differences between the groups will be analyzed. Questions are derived from previous studies.

  11. Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice. [ Time Frame: at 6 months follow-up ]
    Self-reported outcome, questions derived from previous studies.


Other Outcome Measures:
  1. Change on participant's individual diabetes risk. [ Time Frame: at baseline, 6 and 12 months follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234322


Locations
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Germany
German Diabetes Center, Institute for Biometrics and Epidemiology
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Sponsors and Collaborators
German Diabetes Center
Association of Statutory Health Insurance Physicians North Rhine
German Institute of Human Nutrition
Investigators
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Principal Investigator: Wolfgang Rathmann, Prof. German Diabetes Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wolfgang Rathmann, PD Dr. Wolfgang Rathmann MSPH (USA), German Diabetes Center
ClinicalTrials.gov Identifier: NCT03234322    
Other Study ID Numbers: DRT-Study
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Twelve months after data publication, de-identified data can be provided to other researchers upon request.
Supporting Materials: Study Protocol
Time Frame: 12 months
Access Criteria: Universities and other non-profit organizations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wolfgang Rathmann, German Diabetes Center:
prevention
risk score
behaviour
physical activity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases