Protocol summary

Summary
Objectives: Investigation about the effect of training the practical methods of activities of daily living on independence and satisfaction of elderly people. Design: Randomized control trial research. The participants are assigned randomly into two groups of intervention (N=40) and control group (N=40). The two groups are matched for age, gender and educational level. Setting and conduct: Karaj Kahrizak Charity Foundation. Major Inclusion criteria: Elderly above 60 years; Ability to read and write in Persian Major Exclusion criteria: Affected by neurological diseases such as Stroke, Parkinson Disease, Spinal Cord Injuries, and Alzheimer; Mini Mental Status Examination (MMSE) score below than 21 Intervention: The activities of daily living are trained in intervention group by an expert occupational therapist. The treatment protocol consists of two 45-minute group training sessions. The control group receives no training. Four months later, the ability of participants are evaluated again in both groups to determine the effect of training sessions. Main outcome measures: Activities of daily living;َ Activity satisfaction

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101136709N2
Registration date: 2017-11-15, 1396/08/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Mohammad Khayatzadeh Mahani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613743101
Email address
mahany@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Expected recruitment start date
2017-10-10, 1396/07/18
Expected recruitment end date
2018-02-15, 1396/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of training the practical methods of activities of daily living on independence and satisfaction of elderly people.
Public title
Effect of training the practical methods of activities of daily living on independence and satisfaction of elderly people.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Elderly people above 60 years; Ability to read and write in Persian Exclusion criteria: Affected by neurological diseases or disorders such as Stroke,Parkinson Disease, Spinal Cord Injuries, and Alzheimer; Mini Mental Status Examination (MMSE) score below than 21
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization based on random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Commitee of Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of Research and Technology Development, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2017-09-26, 1396/07/04
Ethics committee reference number
IR.AJUMS.REC.1396.486

Health conditions studied

1

Description of health condition studied
Elderly people
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Activities of daily living
Timepoint
Onset of study and 4 month later
Method of measurement
Modified Barthel Index

2

Description
Performance and satisfaction
Timepoint
Onset of study and 4 month later
Method of measurement
Canadian Occupational Performance Measure(COPM)

Secondary outcomes

1

Description
Mental status
Timepoint
Before the study
Method of measurement
Mini Mental Status Examination(MMSE)

Intervention groups

1

Description
Intervention Group: The activities of daily living are trained practically to elderly people in intervention group by an expert occupational therapist through two 45-minute group sessions. The elderly people are trained in groups of 5 people in activities of daily living room. The training method is practical and oral in terms of activities such as toileting, bathing, dressing and grooming. The participants will receive the regular rehabilitation services such as physical therapy and occupational therapy.
Category
Lifestyle

2

Description
Control Group: No specific training are delivered regarding the activities of daily living. The participants will just receive the regular rehabilitation services such as physical therapy and occupational therapy.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj Kahrizak Charity Foundation
Full name of responsible person
Sepideh Riahi
Street address
Isfahaniha Street, Golestanak Street, Mohammad shahr, Karaj, Iran
City
Mohammad shahr, Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology Development, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mr Mehravar
Street address
Golestan bld, Ahvaz jundishapur university of medical sciences, ahvaz, iran
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology Development, Ahvaz Jundishapur University of Medical Sciences
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
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences,Ahvaz Jundishapur
Full name of responsible person
Mohammad Khayatzadeh Mahani
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences,Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz
Postal code
61357-33133
Phone
+98 613743501
Fax
+98 613743506
Email
mahany@ajums.ac.ir
Web page address
http://frehabilitation.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences,Ahvaz Jundishapur
Full name of responsible person
Mohammad Khayatzadeh Mahani
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences,Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
61357-33133
Phone
+98 613743501
Fax
+98 613743506
Email
mahany@ajums.ac.ir
Web page address
http://frehabilitation.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences,Ahvaz Jundishapur
Full name of responsible person
Mohammad Khayatzadeh Mahani
Position
Assistant professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulvard, Ahvaz, Iran
City
Ahvaz
Postal code
61357-33133
Phone
+98 613743501
Fax
+98 613743506
Email
mahany@ajums.ac.ir
Web page address
http://frehabilitation.ajums.ac.ir

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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