Overall objective: Determining the effect of self-management education program on vision related quality of life in elderly patients with visual impairment. Main intervention: Self-management educational program for people with visual impairment . First, the cognitive shortening questionnaire (AMT) for cognitive problems screening fills up for each research unit that is willing to participate in the study. In the case of obtain cognitive ability score of 7 and above, the elderly are included in the study and After completing the informed consent form by research units and obtaining demographic information by a researcher at the clinic of Khatam-ol-Anbia hospital, the elderly were enrolled and randomly assigned to two groups of intervention and control.Before the intervention, the pretest (vision related quality of life tool) was performed in both groups and then the intervention group will be subjected to self-management educational intervention . Program will be based on the educational content . After the end of the intervention and the end of the two-month follow-up, the test is performed using the vision related quality of life tool, and the score obtained from the tool is recorded in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081133966N1
Registration date:2017-08-16, 1396/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Ahmad Ghasemi
Name of organization / entity
Mashhad University of Medical Sciences/Khatam al anbia hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3664 0085
Email address
ghasemia6@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2017-08-12, 1396/05/21
Expected recruitment end date
2017-11-12, 1396/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of self-management educational program on Vision related Quality of life in Elderly with visual Impairment
Public title
The Effect of self-management educational program on Vision related Quality of life in Elderly with visual Impairment
Purpose
Prevention
Inclusion/Exclusion criteria
Entry criteria include: aged 60 and above, average visual acuity, below 6.18 to 6.60 (median vision impairment classified by the World Health Organization and among the diseases including : age-related macular degeneration (AMD), glaucoma, Diabetic retinopathy), Not having acute physical and mental disorder, and cognitive impairment and having cognitive ability of 7 and above (in the cognitive impairment test for AMT), visual and auditory acuity and talking ability to the extent that they are able to participate in the research, Education at reading and writing level, residence in Mashhad
Exit criteria include: Participant refusal to continue cooperation, absence of more than two sessions in the training program, and the occurrence of any physical and mental disorder during an intervention that would prevent an elderly participant in the meetings.
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
self management educational program
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Mashhad University of Medical Sciences
Street address
International Office - Administration Center(Qoreishi Building) – Daneshgah St. – Mashhad – Iran
City
mashhad
Postal code
99191-91778
Approval date
2017-08-09, 1396/05/18
Ethics committee reference number
IR.MUMS.REC.1396.155
Health conditions studied
1
Description of health condition studied
visual Impairment
ICD-10 code
H54.2
ICD-10 code description
Moderate visual impairment, binocular
Primary outcomes
1
Description
Vision related Quality of life
Timepoint
pre intervention, post intervention, post followup Duration
Method of measurement
NEI-VFQ 39
Secondary outcomes
empty
Intervention groups
1
Description
self management educational program
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
khatam al-anbia Eye Hospital
Full name of responsible person
Akbar Derakhshan(MD)
Street address
mashhad -shahid Gharani blvd. between Abootaleb crossroad and Ferdosi squ.- edge of shahid Gharani 41
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences,Vice Chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
International Office - Administration Center(Qoreishi Building) – Daneshgah St. – Mashhad – Iran
City
Mashhad
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,Vice Chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghasemi
Position
Nuesing/Graduate degree
Other areas of specialty/work
Street address
mashhad -shahid Gharani blvd. between Abootaleb crossroad and Ferdosi squ.- edge of shahid Gharani 41
City
Mashhad
Postal code
91959-65919
Phone
+98 51 3728 1401
Fax
Email
ghasemia6@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Karimi Monaghi
Position
nursing education(PH.D) and Medical Education (Masters )/Associate professor
Other areas of specialty/work
Street address
Mashhad- Doctora cross road- ebn sina Ave. Nursing and Midwifery University
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
karimih@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghasemi
Position
Nuesing/Graduate degree
Other areas of specialty/work
Street address
mashhad -shahid Gharani blvd. between Abootaleb crossroad and Ferdosi squ.- edge of shahid Gharani 41
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)