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

NCT03234322 | Completed

• 1 other identifier: DRT-Study
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Primary Prevention

Keywords

prevention; risk score; behaviour; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Improvement in the counseling process assessed by PCPs.

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

• Improvement in the counseling process assessed by participants.

  at 6 months follow-up

• Improvement of shared decision making, assessed by participants.

  at baseline

• Improvement of shared decision making, assessed by PCPs.

  at baseline

• Improved motivation to change lifestyle, assessed by participants.

  at baseline, 6 and 12 months follow-up

Other Outcomes (1)

• Change on participant's individual diabetes risk.

  at baseline, 6 and 12 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

In the control group the routine health check is conducted.

Interventions

external validated risk prediction model 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.

Also known as: The German Diabetes Risk Score

Intervention group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• treat exclusively patients with private insurance
• treat exclusively diabetes patients in a specialized medical practice
• appointment for the routine health check
• insured in statutory health insurance
• age \> 35 years
• Body Mass Index (BMI) of ≥ 27 kg/m2
• 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

Sponsors & Collaborators

• German Diabetes Center: lead
• Association of Statutory Health Insurance Physicians North Rhine: collaborator
• German Institute of Human Nutrition: collaborator

Study Sites (1)

German Diabetes Center, Institute for Biometrics and Epidemiology

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (6)

• 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.

  PMID: 24485859 BACKGROUND

• 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.

  PMID: 22123912 BACKGROUND

• 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.

  PMID: 27898672 BACKGROUND

• 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.

  PMID: 20421559 BACKGROUND

• 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.

  PMID: 35551495 DERIVED

• 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.

  PMID: 30326888 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wolfgang Rathmann, Prof.

  German Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Wolfgang Rathmann MSPH (USA)

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

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 31, 2017
• Study Start: September 13, 2017
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months
• Access Criteria: Universities and other non-profit organizations

Locations

DE (1)