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Optimising the treatment of chronic ischemic heart disease by training general practitioners to deliver very brief advice on physical activity – work package 6 (pragmatic cluster-randomised controlled trial)

Optimising the treatment of chronic ischemic heart disease by training general practitioners to deliver very brief advice on physical activity – work package 6 (pragmatic cluster-randomised controlled trial) - OptiCor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034642
Enrollment
600
Registered
2024-07-10
Start date
2025-03-24
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25

Interventions

Group 1: Intervention group: General practitioners (GPs) from practices in North Rhine-Westphalia (n=25 practices) will receive a previously developed 3.5- hour training in the provision of brief advi

Sponsors

Heinrich-Heine-University Düsseldorf, Medical Faculty
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria general practitioners: General practitioners in private practice or employed in North Rhine-Westphalia specialised in general practice, aged 18 and over, who have German language skills and have given written informed consent prior to study inclusion, and who are willing to participate in the 3.5-hour training. Inclusion criteria patients: All patients with a documented diagnosis of a chronic IHD according to ICD-10 (International Classification of Diseases-10: I25.-I25.9) who personally visit their GP participating in the OptiCor study on the days of data collection and who gave written consent to participate in the study after being approached and informed about the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria general practitioners: Participation in a comparable training or education programme on counselling patients on physical activity (regardless of the disease) within the past five years. Exclusion criteria patients: severe language barriers, moderate to severe cognitive limitations, significant physical limitations that would massively hinder the performance of physical activity in the sense of sporting activity, as well as explicit instructions from the practice teams not to approach certain people about possible study participation (experience shows that this sometimes happens, for example, in patients with dementia, severe mental illness or an acute situation of the heart disease). Furthermore, no patients without personal contact with a general practitioner on the day of the survey will be included in the study (e.g., if they only pick up a prescription, visit the practice to have their blood taken or visit a relative).

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the proportion of patients with IHD who report that their GP discussed the topic of PA promotion with them during their routine consultation. The statistical comparison is made between patients in the GPs’ intervention vs. control group. The survey of patients with IHD on this endpoint takes place as part of a questionnaire-based face-to-face data collection in the practice of GPs of the intervention and control group, and after the consultation with the GP. There will be 5 study cycles over a period of 2 years. A study cycle lasts around ten weeks: 5 weeks of data collection in the control group (n=5 practices) (T0), implementation of the training in GPs of the control and intervention group (T1), followed by 5 weeks of data collection in the intervention group (n=5 practices) (T2).

Secondary

MeasureTime frame
a) As part of the survey of patients with IHD in the intervention and the control group, the following secondary endpoints are to be determined and statistically compared between the intervention and control group. Did the consultation take place in accordance with the 3As brief advice method: - Proportion of patients with IHD whose PA behaviour was assessed (ask) -Proportion of patients with IHD who were advised to be more or more frequently physically active (advise) - Proportion of patients with IHD who received specific recommendations or information on the length, frequency and possibilities of PA and/or information material on PA/PA programmes (assist) - Proportion of patients with IHD who were offered by their GP to discuss/monitor their PA behaviour again or in more detail at a follow-up appointment - and in the subgroup of patients with IHD who discussed the topic of PA with their GP: Satisfaction with the advice received b) Knowledge, motivation and practical skills of GPs in advising on PA promotion: GPs in the control group are interviewed before the training and GPs in the intervention group are interviewed by questionnaire in a 14-day period after the training. c) Process evaluation: With GPs in the intervention group using qualitative interviews: - Personal experiences of GPs with advising on PA following participation in the training - Assessments and their experience of the training on brief advice on PA in individuals with IHD - Factors that promote and hinder the practical transfer of the content learnt, including strategies for routine implementation. With patients with IHD in the intervention group who report receiving GP advice on PA: - Experience and perception of GP advice on PA - Factors that promote and hinder the implementation of GP-advised PA recommendations.

Countries

Germany

Contacts

Public ContactSabrina Hoppe

Institute of General Practice (ifam), Centre for Health and Society (chs), Patient-Physician-Communication research unit, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf

Sabrina.Hoppe@med.uni-duesseldorf.de+49 (0)211/8116816

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026