Recruitment of Patients Through Invitation Letters
Primary Purpose
Recruitment, Invitation Letters, Patients With Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Old invitation letter
New invitation Letter
Sponsored by
About this trial
This is an interventional health services research trial for Recruitment, Invitation Letters, Patients With Schizophrenia focused on measuring Recruitment, Invitation Letter, patients, Schizophrenia
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
Sites / Locations
- Bettina Ellen Grønbech
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
old letter of invitation
New letter of invitation
Arm Description
Old invitation letter written by researchers/doctors in "The coronary project" sent to patients in order to recruit to an ongoing project
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.
Outcomes
Primary Outcome Measures
Response rates to the invitation Letters to be compared
response made to project nurse either by E-mail or phone
Secondary Outcome Measures
Full Information
NCT ID
NCT03590015
First Posted
July 6, 2018
Last Updated
July 23, 2018
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03590015
Brief Title
Recruitment of Patients Through Invitation Letters
Official Title
Recruitment of Patients With Schizophrenia for "The Coronary Disease Project" Through Invitation Letters
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recruitment, Invitation Letters, Patients With Schizophrenia
Keywords
Recruitment, Invitation Letter, patients, Schizophrenia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
old letter of invitation
Arm Type
Other
Arm Description
Old invitation letter written by researchers/doctors in "The coronary project" sent to patients in order to recruit to an ongoing project
Arm Title
New letter of invitation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Old invitation letter
Intervention Description
Invitation Letter written by researchers/doctors
Intervention Type
Other
Intervention Name(s)
New invitation Letter
Intervention Description
Invitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter
Primary Outcome Measure Information:
Title
Response rates to the invitation Letters to be compared
Description
response made to project nurse either by E-mail or phone
Time Frame
within 3 weeks from receiving an invitation Letter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Grønbech, nurse
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bettina Ellen Grønbech
City
Aalborg
State/Province
Northern Part Of Jutland
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
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Recruitment of Patients Through Invitation Letters
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