Recruitment, Invitation Letters, Patients With SchizophreniaNCT03590015
Recruitment of Patients Through Invitation Letters
A study testing Old invitation letter and New invitation Letter in people with Recruitment, Invitation Letters, Patients With Schizophrenia, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Recruitment of patients with schizophrenia to clinical trials is difficult and in an ongoing project different methods of recruitment have been used in order to recruit. One of the methods used have been sending potential participant to the study an invitation letter with information of the study and an invitation to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recruitment, Invitation Letters, Patients With Schizophrenia
- What is being tested?
- Old invitation letter and New invitation Letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 1 Apr 2018
- Phase
- Interventional
- 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
Who may be able to join
- >18 years
- Patients with a diagnosis within the spectre of Schizophrenia (F-20 to F-25) for at least ten years
- At the time of recruitment, a diagnosis of either F-20 or F-25 ( all diagnoses from ICD-10)
- Recidency in the Northern part of Jutland
- In treatment by an outpatient team
- Low frequency of contact with a clinician, once a month at the most
Who cannot join
- No exclusion criteria for receiving an invitation Letter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recruitment of Patients With Schizophrenia for "The Coronary Disease Project" Through Invitation Letters
Recruitment of patients with schizophrenia to clinical trials is difficult and in an ongoing project different methods of recruitment have been used in order to recruit. One of the methods used have been sending potential participant to the study an invitation letter with information of the study and an invitation to make contact with a project nurse. Not many patients have replied.
The aim of this study is to examine whether a simplified version of the invitation Letter, in terms of information structure and written style will encourage more patients to make contact to a project nurse.
Read the detailed description
It is found that patients suffering from Schizophrenia have a positive attitude concerning participation in a research project but this doesn't always lead to recruitment. This might be due to schizophrenia being a disease causing self-disturbances in communication and contact to the surrounding World. It may lead to vulnerability in decision-making an a lower decision making capacity. Language disability is one of the most notable cognitive deficits in patients suffering from Schizophrenia and can be devided in to main components of usage and comprehension. Patients experience poorer listening comprehension and reading comprehension with no correlation to either age or education level and studies have shown that patients with schizophrenia have low literacy.
Therefore the aim of this study is to examine whether a rewritten version of an invitation Letter, taking in consideration patients low literacy and therefore written in simple sentences and with a sequential structure of information will make more patients take contact to a project nurse compared to patients receiving the original invitation Letter. The study design is a randomized controlled trial testing the old letter against the new letter.
- Being tested
- Old invitation letter, New invitation Letter
- Keywords
- Recruitment, Invitation Letter, patients, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Old invitation letterOther
Invitation Letter written by researchers/doctors
New invitation LetterOther
Invitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter
| Study group | Role | What they receive |
|---|---|---|
| old letter of invitation | Other | Old invitation letter written by researchers/doctors in "The coronary project" sent to patients in order to recruit to an ongoing project Receives: Other: Old invitation letter |
| New letter of invitation | Other | New invitation Letter written with consideration of impaired language comprehension and has therefore been written in simple sentences with a sequential structure of basic information sent to patients in an ongoing project. Receives: Other: New invitation Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates to the invitation Letters to be compared
response made to project nurse either by E-mail or phone
Measured: within 3 weeks from receiving an invitation Letter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Feb 2018
- Primary completion1 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recruitment, Invitation Letters, Patients With SchizophreniaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bettina Ellen Grønbech, Aalborg University Hospital
- Investigators
- Bettina Grønbech, nurse, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590015
- Sponsor's protocol ID
- Invitationsbrevet
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruitment of Patients With Schizophrenia for "The Coronary Disease Project" Through Invitation Letters
- ClinicalTrials.gov ID
- NCT03590015
- Acronym / sponsor ID
- Invitationsbrevet
- Keywords
- Recruitment, Invitation Letter, patients, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 18 Jul 2018 (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.
Recruitment of patients with schizophrenia to clinical trials is difficult and in an ongoing project different methods of recruitment have been used in order to recruit. One of the methods used have been sending potential participant to the study an invitation letter with information of the study and an invitation to make contact with a project nurse. Not many patients have replied.
The aim of this study is to examine whether a simplified version of the invitation Letter, in terms of information structure and written style will encourage more patients to make contact to a project nurse.
Detailed description
It is found that patients suffering from Schizophrenia have a positive attitude concerning participation in a research project but this doesn't always lead to recruitment. This might be due to schizophrenia being a disease causing self-disturbances in communication and contact to the surrounding World. It may lead to vulnerability in decision-making an a lower decision making capacity. Language disability is one of the most notable cognitive deficits in patients suffering from Schizophrenia and can be devided in to main components of usage and comprehension. Patients experience poorer listening comprehension and reading comprehension with no correlation to either age or education level and studies have shown that patients with schizophrenia have low literacy.
Therefore the aim of this study is to examine whether a rewritten version of an invitation Letter, taking in consideration patients low literacy and therefore written in simple sentences and with a sequential structure of information will make more patients take contact to a project nurse compared to patients receiving the original invitation Letter. The study design is a randomized controlled trial testing the old letter against the new letter.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| old letter of invitation | Other | Other: Old invitation letterOld invitation letter written by researchers/doctors in "The coronary project" sent to patients in order to recruit to an ongoing project |
| New letter of invitation | Other | Other: New invitation LetterNew invitation Letter written with consideration of impaired language comprehension and has therefore been written in simple sentences with a sequential structure of basic information sent to patients in an ongoing project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years
- Patients with a diagnosis within the spectre of Schizophrenia (F-20 to F-25) for at least ten years
- At the time of recruitment, a diagnosis of either F-20 or F-25 ( all diagnoses from ICD-10)
- Recidency in the Northern part of Jutland
- In treatment by an outpatient team
Key exclusion criteria (1 listed)
- No exclusion criteria for receiving an invitation Letter
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 |
|---|---|---|
| Old invitation letterInvitation Letter written by researchers/doctors | Other | old letter of invitation |
| New invitation LetterInvitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter | Other | New letter of invitation |
Primary outcome
Response rates to the invitation Letters to be compared
Time frame: within 3 weeks from receiving an invitation Letter
response made to project nurse either by E-mail or phone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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.
Bettina Grønbech, nurse principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Old invitation letter and New invitation Letter in people with Recruitment, Invitation Letters, Patients With Schizophrenia, run by Aalborg University Hospital 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rates to the invitation Letters to be compared (time frame: within 3 weeks from receiving an invitation Letter). 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 24 Jul 2018.