Recruitment of Patients Through Invitation Letters

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recruitment of Patients With Schizophrenia for The Coronary Disease Project Through Invitation Letters

Conditions
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Recruitment, Invitation Letters, Patients With Schizophrenia

Intervention / Treatment
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* Other: Old invitation letter
* Other: New invitation Letter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: old letter of invitation<br>Old invitation letter written by researchers/doctors in The coronary project sent to patients in order to recruit to an ongoing project | Other: Old invitation letter<br>* Invitation Letter written by researchers/doctors<br>|
| Other: New letter of invitation<br>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. | Other: New invitation Letter<br>* Invitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates to the invitation Letters to be compared | response made to project nurse either by E-mail or phone | within 3 weeks from receiving an invitation Letter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recruitment, Invitation Letter, patients, Schizophrenia