Protocol summary

Study aim
Determining the effect of remote rehabilitation training on the outcomes of hip osteoarthritis in Patients Referred to Firoozgar hospital
Design
A clinical trial with a control group, parallel, not blinded, randomized, phase 2 on 76 patients. The samples will be allocated into two intervention and control groups by the Block randomization method. by Using non-transparent envelopes sealed with random sequences that the lids of the letter envelopes are glued and placed inside a box, respectively. Finally, one of the envelopes is opened and the assigned group of that participant is revealed.
Settings and conduct
Patients referred to the orthopedic clinic of Firoozgar Hospital in Tehran were randomly selected in two groups. The control group received routine training. But the intervention group will receive a weekly educational intervention of a 30-45 minute session through Skype software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being between the ages of 18 and 75 years, no more than 6 months have passed since the replacement of the hip joint, having access to the Internet and a smartphone and the Skype program Conditions for not entering the study: Exclusion criteria: The presence of mental illnesses and the use of psychotropic drugs, the presence of accompanying orthopedic lesions such as fractures, severe speech disorder
Intervention groups
Intervention group: in this educational intervention group by the researcher, one session per week for 30 to 45 minutes in groups of 4 to 6 people, including definition of osteoarthritis and introduction of hip disease, risk factors, symptoms of the disease, management of the symptoms of the disease , medication, diet, appropriate exercises and pain relief methods will be provided through Skype software. Control group: only routine training will be done .
Main outcome variables
Osteoarthritis Outcome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230807059070N1
Registration date: 2023-09-24, 1402/07/02
Registration timing: registered_while_recruiting

Last update: 2023-09-24, 1402/07/02
Update count: 0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Azadeh Nematolahidavijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4485 0415
Email address
azadeh.nemat1363@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of remote rehabilitation training on the outcomes of hip osteoarthritis in patients after surgery
Public title
Investigating the effect of remote rehabilitation training on the outcomes of hip osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being aged between 18 and 75 years No more than 6 months have passed since the replacement of the hip joint Having access to the Internet and a smartphone and the Skype program
Exclusion criteria:
The presence of mental illnesses and the use of psychotropic drugs according to the patient's statement The presence of accompanying orthopedic lesions such as fractures Severe speech disorder that prevents verbal communication
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will initially be available; The samples will then be placed in quadruple blocks by block random sampling. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
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 Iran University of Medical Sciences
Street address
Rashid Yasmi St, Rashid Yasmi St, Rashid Yasmi St, Tehran
City
Tehran
Province
Tehran
Postal code
88201978
Approval date
2023-04-03, 1402/01/14
Ethics committee reference number
IR.IUMS.REC.1402.002

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site

Primary outcomes

1

Description
Osteoarthritis Outcome
Timepoint
Before and one month after the intervention
Method of measurement
Hip Disability and Osteoarthritis Outcome Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, the educational intervention by the researcher is one session per week for 30 to 45 minutes in groups of 4 to 6 people, including the definition of osteoarthritis and the introduction of hip disease, risk factors, symptoms of the disease, management of disease symptoms, drug therapy. , diet, suitable exercises and pain relief methods will be provided through Skype software.
Category
Rehabilitation

2

Description
Control group: In this group, only routine training will be done.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Azadeh Nematollahi Davijani
Street address
Valadi St, Behafarin St, Karimkhan Ave, Vali-asr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1000
Email
firoozgarhospital1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza falak
Street address
Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8970 1021
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Nematollahi Davijani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rashid Yasmi St, Rashid Yasmi St, Rashid Yasmi St, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 4365 1000
Email
azadeh.nemat1363@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadaee
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rashid Yasmi St, Rashid Yasmi St, Rashid Yasmi St, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 4365 1000
Email
seyedoshohadaee.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Nematollahi Davijani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rashid Yasmi St, Rashid Yasmi St, Rashid Yasmi St, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 4365 1000
Email
azadeh.nemat1363@gmail.com

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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...