Impact of collaborative care model on quality of life in adolescents with glaucoma
Design
A randomized clinical trial in 60 adolescents with glaucoma
Settings and conduct
The research units were selected from among the adolescents with glaucoma who referred to the glaucoma clinic of Khatam-ol-Anbia Ophthalmology Hospital and randomly assigned to the experimental and control groups.
Participants/Inclusion and exclusion criteria
Having an age of 18 to 12 years old, having glaucoma according to the diagnosis of a doctor and not having a known mental disorder
Intervention groups
Intervention: Application of collaborative care model
Control: 15 minutes oral and pamphlet training
Main outcome variables
Quality of life; functional vision
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180816040812N1
Registration date:2018-10-24, 1397/08/02
Registration timing:registered_while_recruiting
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Monir Sedaghat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1401
Email address
sedaghatsm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Collaborative Care Model on quality of life and functional vision in adolescents with glaucoma
Public title
The effect of Collaborative Care Model on quality of life and functional vision in adolescents with glaucoma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
adolescents with glaucoma
Exclusion criteria:
Known mental disorder
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Ibn Sina street, Doctora Intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.MUMS.REC.1397.104
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
Functional vision
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Visual Functional Inventory
2
Description
Quality of life
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: collaborative care model includes the following steps: Step 1: Motivate. Step 2: Preparing and grouping people. Step 3: Involve in 4 sessions within a week. 4: Evaluation at the beginning and end of each session in question and answer And the final evaluation one month after the intervention.
Category
Other
2
Description
Control group: 15 minutes oral and pamphlet training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Alanbia Hospital
Full name of responsible person
Monir Ramezani
Street address
Intersection Doctora, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
RamezaniMN@mums.ac.ir
Web page address
http://www.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
in front of No. 18, Daneshghah Street, Daneshghah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91775 1365
Phone
+98 51 3882 3255
Fax
+98 51 3882 3251
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Monir Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Intersection Doctora, Ibn sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
RamezaniMN@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Monir Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Intersection Doctora, Ibn sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
RamezaniMN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Monir Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Intersection Doctora, Ibn sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
RamezaniMN@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available