- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05863000
Patient Behavior in Region H: How Does Illness Affect How You Act and Master Your Life?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- Recruiting
- Anette Lykke Hindhede
-
Contact:
- Anette Lykke Hindhede
- Phone Number: +4526851917
- Email: anette.lykke.hindhede@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patient is assigned to Region H
- The patient is over the age of 18
- The patient is able to answer the questions
Exclusion Criteria:
- - The patient refuses to give informed consent
- The patient doesn't speak danish
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients in Region H
The health care system in Region H consists of 10 hospitals, including Region H's Psychiatry which consists of 11 centers.
The hospitals annually have around 3 million visits from outpatients
|
Participants are expected to answer a short survey based on their overall experiences with their own health.
No participants will therefore be followed for more than the duration of time it takes a subject to answer the questionnaire (approx 15 minutes).
Randomly selected volunteers of around 30 respondents will afterwards be invited to participate in a qualitative interview with the intend to elaborate their questionnaire responds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Online questionnaire/survey
Time Frame: six months
|
Investigators have developed a medical education survey in Danish for the participants to answer individually or with investigators' help.
Participants are expected to give their informed consent before beginning the survey.
In order to verify the quality of the survey investigators conducted preliminary cognitive interviewing on 10 participants broadly represented by gender, age, diagnosis' etc. Cognitive interviewing is an evidence based qualitative research method designed to investigate if a questionnaire fulfills its intended purpose and thereby ensures to improve education surveys .
With help from an investigator respondents are expected to "think out loud" while answering the questionnaire.
In the questionnaire, investigators ask participants about their socioeconomic background as well as questions about exercise, diets, alcohol, mental well being often in the context of their actions before and after receiving a diagnosis or becoming ill.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multiple correspondence analysis
Time Frame: through study completion, an average of 6 months
|
Investigators plan to interpret investigators' data through a Multiple Correspondence Analysis (MCA) . MCA is a statistical approach utilized among others by sociologist Pierre Bourdieu in order to construct social fields and spaces with his empirical data . Through MCA investigators can analyze the pattern of relationships of several categorical dependent variables such as diagnosis, income, age, diet, geography etc. As such, it can also be seen as a generalization of principal component analysis when the variables to be analyzed are categorical instead of quantitative |
through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P-2022-764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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