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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01187056
Other study ID # 2007-41-1446
Secondary ID
Status Completed
Phase N/A
First received August 20, 2010
Last updated May 8, 2017
Start date November 2007
Est. completion date July 2012

Study information

Verified date October 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication for disease prevention are needed, as are studies about risk communication training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations. Hypothesis: 1) patients have better adherence to chosen treatment.

The effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.

The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction.

The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment, self-rated health, patient enablement, and risk communication and decision-making effectiveness. Prescriptions, contacts to the health services, and cholesterol level will be drawn from the register of the National Health Service of Denmark at baseline and at 6 months.

In both intervention group and active control group, 12 consultations will be observed and tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme. The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to describe and analyse research choices, adaptation of intervention model to the specific context, and GPs' and patients' reactions to trial participation.


Recruitment information / eligibility

Status Completed
Enrollment 179
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- GPs in Region Central and Region North, Denmark, are invited to the study.

Patients are at least 18 years old, and have high cholesterol corresponding to a recommendation for cholesterol-reducing medication according to Danish clinical guideline for general practice. The patients are recruited after their high cholesterol has been detected and when treatment options are to be discussed.

Exclusion Criteria:

- Patients with CVD or DM are excluded from the study, as are patients already receiving cholesterol-reducing medication and patients unable to speak and read Danish.

Study Design


Intervention

Behavioral:
Training programme
2 x 2 hours of training (workshops)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus TrygFonden, Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary The primary patient outcome is adherence to treatment choice. 2010-08-01 - 2011-04-01
Secondary satisfaction with decision. 2010-08-01 - 2011-04-01
Secondary self-rated health 2010-08-01 - 2011-04-01
Secondary anxiety 2010-08-01 - 2011-04-01
Secondary enablement 2010-08-01 - 2011-04-01
Secondary satisfaction with communication, 2010-08-01 - 2011-04-01
Secondary satisfaction and confidence in decision 2010-08-01 - 2011-04-01
Secondary number of contacts to health services 2010-08-01 - 2011-04-01
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