Recruitment of Patients Through Invitation Letters
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Northern Part Of Jutland
-
Aalborg, Northern Part Of Jutland, Denmark, 9000
- Bettina Ellen Grønbech
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >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
Exclusion Criteria:
- No exclusion criteria for receiving an invitation Letter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: old letter of invitation
Old invitation letter written by researchers/doctors in "The coronary project" sent to patients in order to recruit to an ongoing project
|
Invitation Letter written by researchers/doctors
|
|
Other: New letter of invitation
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.
|
Invitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
within 3 weeks from receiving an invitation Letter
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bettina Grønbech, nurse, Aalborg University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Invitationsbrevet
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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