Protocol summary

Study aim
Determining the effect of self-management intervention on quality of life, health status and self-management in patients with scleroderma .
Design
The design of the study will be a randomized clinical trial with a control group - parallel groups - two-way blind.
Settings and conduct
the officials of Hafez Educational and Medical Center affiliated to Shiraz University of Medical Sciences - To Two way blind the study, participants are given a full explanation of how to perform the intervention before the intervention,
Participants/Inclusion and exclusion criteria
Patients with a definitive diagnosis of scleroderma who have been diagnosed with the disease for one year and have sufficient experience of the details and problems of the disease If they do not want to continue the collaboration at any stage of the research, they can be excluded from the study. Misery and inability of the patient .
Intervention groups
Both groups will be under routine care. Self-management education program will be implemented only for intervention groups
Main outcome variables
Quality of life - Health status assessment - Self-management Description of Outcome Variable 1: Quality of Life Before the intervention and after the intervention Quality of Life Questionnaire Description of Outcome Variable 2: Health status assessment Before the intervention and after the intervention Health status assessment questionnaire Outcome variable description 3: self management Before the intervention and after the intervention Self-management questionnaire Intervention Description: The intervention will be performed as a self-management program training for the intervention group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191021045178N4
Registration date: 2021-06-15, 1400/03/25
Registration timing: prospective

Last update: 2021-06-15, 1400/03/25
Update count: 0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Nilofar Pasyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 6293
Email address
pasyarn@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management intervention on quality of life, health status and self-management in patients with scleroderma
Public title
The effect of self-management program on quality of life, health status and self-management of scleroderma patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients referred to the rheumatology department and rheumatology clinic with a definite medical diagnosis of scleroderma.2. Patients who have been diagnosed with scleroderma for one year and have sufficient experience of the details and problems of the disease3. Have the desired physical, mental and cognitive ability to participate in research.4. Be able to express and speak in Persian.5. People who want to participate in the study.
Exclusion criteria:
1. If they do not want to continue cooperation at any stage of the research, they can be excluded from the study.2. Illness and inability of the patient to lead to hospitalization and the person is not able to continue participating in the research.3. Occurrence of any physical or mental accident during the last six months and during the study period that affects his physical and mental condition.4. Having a chronic mental illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, according to the list of patients in the clinic, a list of patients who meet the inclusion criteria is determined. Then sampling will be done by systematic random method. Select the appropriate distance (k) and select the names at equal intervals along the list. The distance or k is obtained by dividing the number of members of the study population by the number of members in the sample. It should be noted that the starting point for this regular selection process is random and is done from a table of random numbers. To include people in the study as an example. Then, using blocking software, people will be randomly placed in two blocks, A and B. Using this method, the number of people assigned to each block will be equal. Finally, by tossing coins, each block will be placed in two groups of control and intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, participants are given a full explanation of how to perform the intervention before the intervention, but participants are unaware of the allocation of study groups. Also, in collecting data and completing questionnaires, the help of a researcher who is not aware of the division of groups will be used. Also, the statistician who analyzes the data will not know about the allocation of groups.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-02-07, 1399/11/19
Ethics committee reference number
IR.SUMS.REC.1399.1211

Health conditions studied

1

Description of health condition studied
Self-managment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life before and after the intervention, Quality of life questionnaire score 2: Health status assessment before and after the intervention, Health status assessment questionnaire score 3: Self-management before and after the intervention, Self-management questionnaire score
Timepoint
before and after the intervention
Method of measurement
Quality of Life Questionnaire Health Status Assessment Questionnaire Self-Management Questionnaire

Secondary outcomes

1

Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
Quality of life questionnaire for patients with scleroderma

2

Description
General health assessment
Timepoint
Before and after the intervention
Method of measurement
Stanford General Health Scale

3

Description
self management
Timepoint
Before and after the intervention
Method of measurement
Self-efficacy questionnaire for self-management in chronic patients

Intervention groups

1

Description
Intervention group: Self-management education program-Get routine care
Category
Other

2

Description
Control group: Get routine care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Educational and Medical Center affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Niloofar Pasyar
Street address
زند، روبروی خیابان فلسطین، ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City
SHIRAZ
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
info@sums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
یونس قاسمی
Street address
زند، روبروی خیابان فلسطین، ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
info@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Niloofar Pasyar
Position
Assistant Professor - Faculty member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
زند، روبروی خیابان فلسطین، ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
pasyarn@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Niloofar Pasyar
Position
Assistant Professor Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3647 4254
Fax
+98 71 3230 8200
Email
Npasyar@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Niloofar Pasyar
Position
Assistant Professor Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
pasyarn@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Providing information without personal details of the participants will be confidential
When the data will become available and for how long
After studying and printing the results
To whom data/document is available
The results of the research will be provided to the participants and relevant organizations upon request.
Under which criteria data/document could be used
Obtaining permission from the relevant authorities in the faculty, university and hospital. Keeping participants' information confidential
From where data/document is obtainable
Shiraz. Zand St., Library of Shiraz School of Nursing and Midwifery
What processes are involved for a request to access data/document
The request for the results will be sent to the library of Shiraz School of Nursing and Midwifery. It will be provided to them with the coordination done.
Comments
Loading...