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OpenTrials
Completed

NCT Number: NCT03590015

Recruitment of Patients 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bettina Ellen Grønbech

Aalborg, Northern Part of Jutland, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Old invitation letter

Other

Invitation Letter written by researchers/doctors

New invitation Letter

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2018
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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