- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046940
The Influence of Doctor-patient Communication on Patients' Willingness to Take Medication
June 8, 2017 updated by: Winfried Rief, Philipps University Marburg Medical Center
The experiment aims at investigating whether the doctor-patient communication has an influence on patients' willingness to take medication.
Patients' attitude towards the medication is manipulated via a critical film sequence.
Afterwards patients of the two experimental groups have a communication with one of the investigators of the study.
Patients are told that the investigator is a medical doctor.
The "doctors" either communicate in a patient-centered or doctor-centered style with the patient.
Patients in the control group do not have the possibility to talk to a "medical doctor".
Afterwards patients are offered the aforementioned pill that is supposed to be a cognitive enhancer (actually placebo pill).
Pill intake is voluntary.
The investigators hypothesize that patients in the experimental group with the patient-centered style of communication are more likely to take the pill than patients in the experimental group with the doctor-centered style of communication or patients in the control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marburg, Germany, 35032
- Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female
- between 18 and 35 years
- healthy
- adequate ability to see
- fluent in German (reading and writing)
Exclusion Criteria:
- regular intake of cognitive enhancers/medication that enhances concentration
- intake of psychotropic drugs
- medical or pharmacy students, advanced psychology students
- participants who know the investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
No communication with a doctor
|
|
|
Experimental: Patient-centered
Participants communicate with a doctor that uses a patient-centered style of communication
|
Different doctor-patient communication
|
|
Experimental: Doctor-centered
Participants communicate with a doctor that uses a doctor-centered style of communication
|
Different doctor-patient communication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pill intake
Time Frame: Within 10 minutes after doctor-patient communication
|
Behavioural test
|
Within 10 minutes after doctor-patient communication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to take medication (VAS)
Time Frame: Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication
|
Visual analogue scale (VAS)
|
Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication
|
|
Critical attitude towards the medication (VAS)
Time Frame: Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication
|
Visual analogue scale (VAS)
|
Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication
|
|
Influence on concentration (Concentration task)
Time Frame: Directly (within 10 minutes) after the pill was offered
|
Concentration task
|
Directly (within 10 minutes) after the pill was offered
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Winfried Rief, PhD, Prof, Philipps University Marburg Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2017
Primary Completion (Actual)
June 8, 2017
Study Completion (Actual)
June 8, 2017
Study Registration Dates
First Submitted
January 30, 2017
First Submitted That Met QC Criteria
February 6, 2017
First Posted (Estimate)
February 8, 2017
Study Record Updates
Last Update Posted (Actual)
June 9, 2017
Last Update Submitted That Met QC Criteria
June 8, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2016-37v-r
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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