Protocol summary

Study aim
The effect of post-discharge telephone follow-up on daily living activities and quality of life in the elderly undergoing cataract surgery
Design
Randomized clinical trial, without blinding, 112 elderly undergoing cataract surgery, easy primary sampling based on the purpose and divided into two equal groups randomly.
Settings and conduct
The study was conducted without blinding in Valiasr Borujen Hospital. After surgery and before discharge, the questionnaire of daily life activities and quality of life related to vision is completed through an interview with the patient. The contact number will be obtained from the patient or the companion and the researcher will call for confirmation. In the intervention group, routine training and home care training according to scientific nursing resources are given. Phone follow-up is done on the third day, second week after surgery between 8-12 AM and questions are answered. The control group will be trained at the time of discharge, without telephone follow-up. One month after the surgery, the questionnaires will be completed and analyzed again by phone.
Participants/Inclusion and exclusion criteria
inclusion criteria:65 years and older, Having and answering the phone, not having a history of acute physical, mental and cognitive disorders, unilateral cataract surgery. Exclusion criteria: speech and hearing impairment, history of cataract surgery by the patient or his wife. Attrition: occurrence of any physical or mental disorder during the intervention, unwillingness to continue cooperation, answering less than two phone calls, death of subjects.
Intervention groups
Control group: routine training of discharge Intervention group: routine training + home care training according to scientific nursing resources, telephone follow-up on the third day, second week after surgery
Main outcome variables
daily living activities ،quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240429061599N1
Registration date: 2024-06-09, 1403/03/20
Registration timing: registered_while_recruiting

Last update: 2024-06-09, 1403/03/20
Update count: 0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
Parvin Malekmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3452 3853
Email address
malekmparvin646@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-26, 1403/02/07
Expected recruitment end date
2024-07-28, 1403/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telephone follow-up after discharge on daily activities and quality of life of elderly people undergoing cataract surgery
Public title
The effect of telephone follow-up on daily activities and quality of life of the elderly undergoing cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 65 years and older Having a self phone Ability to answer the phone undergoing unilateral cataract surgery
Exclusion criteria:
Cataract surgery history of the patient or spouse history of mental and cognitive disorders
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that the nature of the intervention is educational, there is no possibility of blinding the participants. Patients will be assigned to groups in the order of arrival and based on the randomization sequence that will be generated in advance.The sample size is 112 older people and it is divided into two groups of 56 person in control group and 65 person in intervention group. To assign samples to two groups, the block randomization method with the size of six blocks using block random number generator software will be used. All this will be done with software called Sealed Envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Vice President of Research and Technology of Shahid Sadoughi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd, Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
IR.SSU.REC.1403.006

Health conditions studied

1

Description of health condition studied
cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract

Primary outcomes

1

Description
daily living activities
Timepoint
before and one month after cataract surgery
Method of measurement
Activities of Daily Living Questionnaire (ADL)

Secondary outcomes

1

Description
quality of life
Timepoint
before and one month after cataract surgery
Method of measurement
Quality of Life Related to Vision Questionnaire (VFQ-25)

Intervention groups

1

Description
Control group: Discharge time training without telephone follow-up
Category
Prevention

2

Description
Intervention group: Routine training at the time of discharge and home care training in accordance with scientific nursing resources, telephone follow-up on the third day, second week after surgery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Valieasr Borujen Hospital
Full name of responsible person
Parvin Malek mohammadi
Street address
No.37، Hijrat AlleY، Enghelab St
City
Faradonbe
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88741-64996
Phone
+98 38 3452 3853
Email
malekmparvin646@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Vice President of Research and Technology of Shahid Sadoughi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd, Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3623 8506
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Yazd University of Medical Sciences
Full name of responsible person
Khadije Nasiriani
Position
PhD in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery ,Buali St, Safaieh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 9702
Email
nasiriani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
PhD in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery ,Buali St, Safaieh College of Nursing and Midwifery - Safia - Buali St. - Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 9702
Email
nasiriani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Parvin Malekmohammmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.37، Hijrat Alley، Enghelab St
City
Faradonbe
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88741-64996
Phone
+98 38 3452 3853
Email
malekmparvin646@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Researcher that work in academic and scientific institutes can access to demographic variable and daily life activity and quality of life related to vision,of this study.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researcher that work in academic and scientific institutes can access to data.
Under which criteria data/document could be used
you can analyses data with SPSS but you do not access to confidential patient data.
From where data/document is obtainable
if you need to access to data,you can call with me or send email for me. Call number:09138874117 Email: malekmparvin646@gmail.com
What processes are involved for a request to access data/document
After I receive your request,I send them after 10 -30 days.
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