Protocol summary

Summary
Foot and toenail problem are so common in older adults. that only by performing simple care can improve many of these problems and prevent recurrence and improve the quality of life. This study aimed to determine The effect of foot and toenail care’s protocol on quality of life and the rate of foot and toenail problems’ prevalence at non diabetic elderly people.This quasi-experimental study included 2 groups before and after.sample size calculation 54 people per group. Demographic Data Questionnaire, M M SE Questionnaire, Foot and Toenail Problems Questionnaire and Protocol Satisfaction Questionnaire were used to collect data.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092324165N1
Registration date: 2016-01-17, 1394/10/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Mahtab Sharif Mohseni
Name of organization / entity
University of Social Welfare and Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 8830 1125
Email address
ma.sharifmohseni@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-04-28, 1394/02/08
Expected recruitment end date
2015-06-13, 1394/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot and toenail cares protocol on quality of life and the rate of foot and toenail problems prevalence at non diabetic older adults
Public title
The effect of Foot and Toenail Care Protocol on foot and toenail problems and Quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age over 60 years; Having the ability to read and speak the native language (Farsi); Earn a minimum score of 25 in the case of diabetes MMSE Exclusion criteria: frequent absences from meetings or give up client to participate in study; unwillingness to provide cooperation after the start of the study for any reason
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
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
University Of Social Welfare And Rehabilitation Sciences
Street address
Kodakyar avenue, Daneshjoo blvd, Evin street
City
Tehran
Postal code
Approval date
2014-05-02, 1393/02/12
Ethics committee reference number
USWR.REC.1393.212

Health conditions studied

1

Description of health condition studied
foot and toenail problems
ICD-10 code
Z75.3,Z47.
ICD-10 code description
Unavailability and inaccessibility of health-care facilities,Orthopaedic follow-up care, unspecified

Primary outcomes

1

Description
foot and toenail problems
Timepoint
befor intervention,at the end of intervention
Method of measurement
foot and toenail problems checklist

2

Description
quality of life
Timepoint
befor intervention,at the end of intervention
Method of measurement
SF12 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
at the first meeting of all check lists completed. In all the cases booklet, film and bags needed to do was take care during the study. after completing the questionnaire and determine the level of care care and foot and toenail care was care provided
Category
Treatment - Other

2

Description
Control group: The control group was asked to do what they did in the past to take care of your feet and nail to run.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Seniors Association 4th region tehran
Full name of responsible person
Nazila Salman zade
Street address
Golha alley, Kazem Musavi street, heravi square, Panahi nia street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Univercity of Social Walfare and Rehabilitation Science
Full name of responsible person
Mohammad Ali Hosseini
Street address
Kodakyar avenue, Daneshjoo blvd, Evin street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Univercity of Social Walfare and Rehabilitation Science
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
University of Social Welfare and Rehabilitation
Full name of responsible person
Mahtab Shart
Position
Master student of geriatric nursing
Other areas of specialty/work
Street address
N.8, Moshiri alley,North Mofatteh street,Motahhari street
City
Tehran
Postal code
Phone
+98 88301125
Fax
Email
ma.sharifmohseni@uswr.ac.irmb.shfmi@gmail.commb_shfmi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Dr.Mohammad Ali Hosseini
Position
Head of Rehabilitation Management Department, Associate Professor of University of Social Welfare an
Other areas of specialty/work
Street address
Rehabilitation Management Department, University of Social Welfare and Rehabilitation, Kodakyar avenue, Daneshjoo blvd, Evin street
City
Tehran
Postal code
Phone
+98 22180132
Fax
Email
mahmaimy2020@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Mahtab Sharif Mohseni
Position
Master student of geriatric nursing
Other areas of specialty/work
Street address
No 8, Moshiri Alley, Mofatteh Ave, Mottahari Ave
City
Tehran
Postal code
Phone
008988301125
Fax
Email
ma.sharifmohseni@uswr.ac.irmb.shfmi@gmail.commb_shfmi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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