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Influence of Intervention Methodologies on Patient Choice of Therapy

NCT01414751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2013-01-10

No results posted yet for this study

Summary

Few studies have explored how specific formats of effectiveness information effect on real patients' decisions. We only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.

The trial is developed in a clinical randomised design to study risk communication in the shared decision making between general practitioners (GP) and their patients in primary prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about treatment effectiveness and their patients' values on patients' tendency to accept and adhere to the treatment as well as their feeling of content with the choice made. GPs are randomised to inform about risk and treatment effectiveness by means of either absolute risk reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires concerning their content with decisions and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through an electronic database.

57 GPs and 248 patients have been enrolled in the trial.

Conditions

Interventions

BEHAVIORAL

Absolute risk reduction

Patients receive effectiveness information concerning cholesterol lowering therapy by means of absolute risk reduction

BEHAVIORAL

Prolongation of life

Patients receive effectiveness information concerning cholesterol lowering therapy by means of prolongation of life/life extension.

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Dorte E Jarbol, MD PhD · Research Unit of General Practice, Institute of Public Health, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-06-30
Completion
2013-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01414751 on ClinicalTrials.gov