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Recruitment of Patients Through Invitation Letters

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03590015
Enrollment
84
Registered
2018-07-18
Start date
2018-02-01
Completion date
2018-04-01
Last updated
2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recruitment, Invitation Letters, Patients With Schizophrenia

Keywords

Recruitment, Invitation Letter, patients, Schizophrenia

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.

Interventions

OTHEROld invitation letter

Invitation Letter written by researchers/doctors

OTHERNew invitation Letter

Invitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Response rates to the invitation Letters to be comparedwithin 3 weeks from receiving an invitation Letterresponse made to project nurse either by E-mail or phone

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026