Thesis Title: Investigating the effect of nurse -led telephone based follow-up on the participation rate of firstdegree relatives of elderly patients with glaucoma in screening program
Determining the effect of nurse telephone follow-up on the participation of primary family members of the elderly with glaucoma in the screening program
Design
The trial in the field of random trial field is in parallel on two control and test groups with 110 samples by quadruple random blocks method and with the guidance of methodology consultant and analysis with SPSS software.
Settings and conduct
The study site is Mahdkramat Ophthalmology Clinic in Semnan.
Samples are selected from first-degree relatives 35 years and older of patients with glaucoma who have recently been diagnosed by an ophthalmologist
Participants/Inclusion and exclusion criteria
Inclusion criteria nclude:
1- First-degree relatives (parents, children, siblings) of the elderly referring to the eye clinic whose glaucoma has been confirmed by an ophthalmologist during the last three months
2. Have access to the telephone at home
3. At least one family member is 35 years old or older
exclusion criteria nclude:
1- Not wanting to participate in the study
2. Impossibility of communication with the patient's family
3. The patient's family member is involved in other clinical studies of glaucoma screening
Intervention groups
The intervention group includes a relative of 35 years and older with glaucoma who is screened and encouraged to receive treatment by telephone and is finally trained.
Main outcome variables
Participation rate in glaucoma screening test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100811004548N2
Registration date:2022-02-02, 1400/11/13
Registration timing:registered_while_recruiting
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Nahid Hoshmand motlagh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3105 2114
Email address
hoshmand@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thesis Title: Investigating the effect of nurse -led telephone based follow-up on the participation rate of firstdegree relatives of elderly patients with glaucoma in screening program
Public title
Thesis Title: Investigating the effect of nurse -led telephone based follow-up on the participation rate of firstdegree relatives of elderly patients with glaucoma in screening program
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
First-degree relatives (parents, children, siblings) of regular clients of Mahde kramat Semnan Ophthalmology Clinic who have been diagnosed with glaucoma for the first time in the last three months
Elderly glaucoma has recently been confirmed by a clinic ophthalmologist
Be at least one first-degree family member 35 years of age or older
Have access to the telephone at home
Exclusion criteria:
Oblivion of a patient with glaucoma and not remembering the phone number of any family member
Participation of the patient's family member in other studiesClinical glaucoma screening
Hearing and speech disorders cause problems for telephone interaction
Has a history of mental, intellectual, forgetfulness problems and treated with sedatives,Hypnotic and psychoactive
Age
From 35 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
A list of the number of first-degree high-risk individuals in each family and their contact numbers are prepared in order of identification time until the sample size is completed, and first-degree members of the patient's family are assigned to one of the two intervention or control groups. To ensure the equality of the number of people in the two groups, the list is prepared using the method of quadruple random block blocks and with the guidance of a methodology consultant.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shahid Sadoughi University of Medical Sciences, Central Building, Shahid Bahonar Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.SSU.REC.1400.163
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40.05
ICD-10 code description
Ocular hypertension
Primary outcomes
1
Description
Participate in the glaucoma screening test
Timepoint
Measurement will be at the beginning of the study and three months later
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First-degree relatives of an elderly person over 35 years of age with newly diagnosed glaucoma will be examined by telephone through a pre-arranged letter for three consecutive months.A telephone call is once a month during which a needs assessment is performed and information and education is given about glaucoma and its treatment and prevention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahde Keramat Charity
Full name of responsible person
Pouran Hooshmand Motlagh
Street address
NO. 16،Hakim Elahi Boulevard، Semnan
City
Semnan
Province
Semnan
Postal code
35186-85866
Phone
+98 23 3336 0002
Fax
+98 35 1868 5866
Email
phooshmand98@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Amir Houshang Mehrparvar
Street address
Shahid Sadoughi University of Medical Sciences, Central Building, Shahid Bahonar Boulevard, Yazd
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyd Aliasghar Mosavi
Position
Research Associate in VHRC
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No. 57، Arasteh Alley، Manzarieh
City
Tehran
Province
Tehran
Postal code
1914853185
Phone
+98 21 2260 5915
Email
a_a_mosavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farahnaz Farnia
Position
Lecturer - Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery، Bouali St، Commander Fallahi, Safaieh neighborhood
City
yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 1751
Fax
+98 35 1824 9705
Email
far.farnia@yaho.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
pouran hooshmand motlagh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery، Bouali St، Commander Fallahi, Safaieh neighborhood
City
yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 9706
Fax
+98 35 1824 9705
Email
phooshmand98@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the screening questionnaire of first-degree relatives of elderly patients with glaucoma will be statistically analyzed and reported after non-identification of individuals.
When the data will become available and for how long
The access period will start six months after the results are published.
To whom data/document is available
Access to the data of this study is free.
Under which criteria data/document could be used
Studying the documents and using the questionnaire and data obtained from the study is free
From where data/document is obtainable
Corresponding author:
Farahnaz Farnia, PhD; Research Center for Nursing and Midwifery Care, Nursing- Midwifery School of
Shahid Sadoughi University, Boali St, Safaeeye, Postal code 8916877391, Yazd, Iran
Tel: +98 35 38245777; Fax: +98 351 8249705; Email: far.farnia@yahoo.com
What processes are involved for a request to access data/document
The applicant can receive the documents after sending the application by email and also by phone and coordination.