Clinical trial NCT03234322: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Primary Prevention
Keywords: prevention
risk score
behaviour
physical activity
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
Collaborators: name: Association of Statutory Health Insurance Physicians North Rhine
name: German Institute of Human Nutrition
First posted: 2017-07-31
Enrollment: 315
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Difference of participant's physical activity at twelve months after the routine health check between the groups.
timeFrame: at baseline, 6 and 12 months follow-up
Secondary outcomes:
measure: Improvement in the counseling process assessed by PCPs.
timeFrame: at baseline and up to one year after the PCP entered the study
measure: Improvement in the counseling process assessed by participants.
timeFrame: at 6 months follow-up
measure: Improvement of shared decision making, assessed by participants.
timeFrame: at baseline
measure: Improvement of shared decision making, assessed by PCPs.
timeFrame: at baseline
measure: Improved motivation to change lifestyle, assessed by participants.
timeFrame: at baseline, 6 and 12 months follow-up
measure: Change in Body-Mass-Index (BMI)
timeFrame: at baseline, 6 and 12 months follow-up
measure: Change in participant's quality of life.
timeFrame: at baseline, 6 and 12 months follow-up
measure: Change in participant's level of depression and anxiety.
timeFrame: at baseline, 6 and 12 months follow-up
measure: Change of participant's perceived risk of developing diabetes.
timeFrame: at baseline, 6 and 12 months follow-up
measure: Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice.
timeFrame: at baseline, and up to one year after the PCP entered the study
measure: Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice.
timeFrame: at 6 months follow-up
Other outcomes:
measure: Change on participant's individual diabetes risk.
timeFrame: at baseline, 6 and 12 months follow-up
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Center, Institute for Biometrics and Epidemiology
state: North Rhine-Westphalia
Study officials:
affiliation: German Diabetes Center
name: Wolfgang Rathmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.