Comparison, SocialNCT05863000
Patient Behavior in Region H: How Does Illness Affect How You Act and Master Your Life?
An observational study of Comparison, Social, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study investigates how the behavior within different patient groups are affected differently by illness and disease. The investigators ask how participants experience and approach their own health in order to gain insight on the implications of illness and disease on the individual's everyday life and how… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison, Social
- What is being tested?
- Online questionnaire/survey
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population consists of patients connected to a hospital clinic in Region H. We aim for a representative sample of patients in general and specific patient groups connected to a hospital within Region Hovedstaden
Who may be able to join
- The patient is assigned to Region H
- The patient is over the age of 18
- The patient is able to answer the questions
Who cannot join
- - The patient refuses to give informed consent
- The patient doesn't speak danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Anette Lykke Hindhede
Copenhagen, 2200
Anette Lykke Hindhede, +4526851917, anette.lykke.hindhede@regionh.dk
About this study
This study investigates how the behavior within different patient groups are affected differently by illness and disease. The investigators ask how participants experience and approach their own health in order to gain insight on the implications of illness and disease on the individual's everyday life and how participants act and think regarding their own health and wellbeing across different patient groups. The investigators' hypothesis is that illness and disease is experienced as a great disturbance and an actor of change in a person's everyday life. Each person has their own individual experience and reaction to this disturbance. Still, there is less evidence for how disparate resources and socioeconomic statuses shape how patients react to this great change in their lives. Here the investigators expect to find demographic patterns across patient groups. The study carries a quantitative and qualitative approach with a broad target population which includes both patients with acute or chronic, serious, or less serious, somatic as well as psychiatric illnesses. The study is placed within the academic traditions of sociological health and disease mapping.
- Conditions
- Comparison, Social
- Being tested
- Online questionnaire/survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaire/surveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Online questionnaire/survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online questionnaire/survey
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.
Measured: six months
Secondary outcomes (1)
Multiple correspondence analysis
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
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Feb 2023
- Primary completionSep 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison, SocialStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anette Lykke Hindhede, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863000
- Sponsor's protocol ID
- P-2022-764
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Behavior in Region H: How Does Illness Affect How You Act and Master Your Life?
- ClinicalTrials.gov ID
- NCT05863000
- Acronym / sponsor ID
- P-2022-764
- Conditions
- Comparison, Social
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates how the behavior within different patient groups are affected differently by illness and disease. The investigators ask how participants experience and approach their own health in order to gain insight on the implications of illness and disease on the individual's everyday life and how participants act and think regarding their own health and wellbeing across different patient groups. The investigators' hypothesis is that illness and disease is experienced as a great disturbance and an actor of change in a person's everyday life. Each person has their own individual experience and reaction to this disturbance. Still, there is less evidence for how disparate resources and socioeconomic statuses shape how patients react to this great change in their lives. Here the investigators expect to find demographic patterns across patient groups. The study carries a quantitative and qualitative approach with a broad target population which includes both patients with acute or chronic, serious, or less serious, somatic as well as psychiatric illnesses. The study is placed within the academic traditions of sociological health and disease mapping.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in Region H | – | Other: Online questionnaire/surveyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population consists of patients connected to a hospital clinic in Region H. We aim for a representative sample of patients in general and specific patient groups connected to a hospital within Region Hovedstaden
Key inclusion criteria (3 listed)
- The patient is assigned to Region H
- The patient is over the age of 18
- The patient is able to answer the questions
Key exclusion criteria (2 listed)
- - The patient refuses to give informed consent
- The patient doesn't speak danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnaire/surveyParticipants 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. | Other | Patients in Region H |
Primary outcome
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.
1 secondary outcome
Multiple correspondence analysis
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison, Social, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online questionnaire/survey (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.