Clinical trial NCT03590015: Recruitment of Patients Through Invitation Letters
Official title: Recruitment of Patients With Schizophrenia for "The Coronary Disease Project" Through Invitation Letters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recruitment, Invitation Letters, Patients With Schizophrenia
Keywords: Recruitment
Invitation Letter
patients
Schizophrenia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rates to the invitation Letters to be compared
timeFrame: within 3 weeks from receiving an invitation Letter
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Bettina Ellen Grønbech
state: Northern Part Of Jutland
Study officials:
affiliation: Aalborg University Hospital
name: Bettina Grønbech, nurse
role: PRINCIPAL_INVESTIGATOR
References: