Type 2 Diabetes MellitusNCT03234322
The Impact of a Diabetes Risk Prediction Model in Primary Care.
A study testing external validated risk prediction model in people with Type 2 Diabetes Mellitus and Primary Prevention, run by German Diabetes Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Primary Prevention
- What is being tested?
- external validated risk prediction model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteGermany
- Study dates
- 13 Sep 2017to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- appointment for the routine health check
- insured in statutory health insurance
- age > 35 years
- Body Mass Index (BMI) of ≥ 27 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Diabetes Center, Institute for Biometrics and Epidemiology
Düsseldorf, North Rhine-Westphalia, 40225
About this study
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.
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Primary Prevention
- Being tested
- external validated risk prediction model
- Keywords
- prevention, risk score, behaviour, physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external validated risk prediction modelOther
Also called The German Diabetes Risk Score
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In the intervention group the routine health check is expanded by usage of a non-invasive diabetes risk score. Receives: Other: external validated risk prediction model |
| Control group | No intervention | In the control group the routine health check is conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, 6 and 12 months follow-up
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start13 Sep 2017
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Statutory Health Insurance Physicians North Rhine, German Institute of Human Nutrition
- Responsible party
- Principal investigator, Wolfgang Rathmann, German Diabetes Center
- Investigators
- Wolfgang Rathmann, Prof., Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234322
- Sponsor's protocol ID
- DRT-Study
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2017
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Twelve months after data publication, de-identified data can be provided to other researchers upon request.
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.
PubMed 24485859Noble 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.
PubMed 22123912Godino 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.
PubMed 27898672Muller-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.
PubMed 20421559Seidel-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.
PubMed 35551495Jacobs 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.
PubMed 30326888
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03234322
- Acronym / sponsor ID
- DRT-Study
- Conditions
- Type 2 Diabetes Mellitus, Primary Prevention
- Keywords
- prevention, risk score, behaviour, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Collaborators
- Association of Statutory Health Insurance Physicians North Rhine, German Institute of Human Nutrition
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: external validated risk prediction modelIn the intervention group the routine health check is expanded by usage of a non-invasive diabetes risk score. |
| Control group | No intervention | –In the control group the routine health check is conducted. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- appointment for the routine health check
- insured in statutory health insurance
- age > 35 years
- Body Mass Index (BMI) of ≥ 27 kg/m2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external validated risk prediction modelAlso: The German Diabetes Risk ScoreThe 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 | Intervention group |
Primary outcome
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.
11 secondary outcomes
Improvement in the counseling process assessed by PCPs.
Time frame: at baseline and up to one year after the PCP entered the study
Improvement in the counseling process assessed by participants.
Time frame: at 6 months follow-up
Improvement of shared decision making, assessed by participants.
Time frame: at baseline
Improvement of shared decision making, assessed by PCPs.
Time frame: at baseline
Improved motivation to change lifestyle, assessed by participants.
Time frame: at baseline, 6 and 12 months follow-up
Change in Body-Mass-Index (BMI)
Time frame: at baseline, 6 and 12 months follow-up
Change in participant's quality of life.
Time frame: at baseline, 6 and 12 months follow-up
Change in participant's level of depression and anxiety.
Time frame: at baseline, 6 and 12 months follow-up
Change of participant's perceived risk of developing diabetes.
Time frame: 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.
Time frame: 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.
Time frame: at 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Background: PubMed 24485859Dhippayom 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.
- Background: PubMed 22123912Noble 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.
- Background: PubMed 27898672Godino 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.
- Background: PubMed 20421559Muller-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.
- Derived from this study: PubMed 35551495Seidel-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.
- Derived from this study: PubMed 30326888Jacobs 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.
- Individual participant dataSharing planned: Yes. Twelve months after data publication, de-identified data can be provided to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Rathmann, Prof. principal investigator
German Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external validated risk prediction model in people with Type 2 Diabetes Mellitus and Primary Prevention, run by German Diabetes Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03234322, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.