Determine the effect of care based on family nursing model on treatment compliance and activity of daily living (ADL) in osteoporosis patients
Design
In this clinical trial study with control group and parallel groups, one side blinded, randomized and without having an precedent of the study phase, 40 people will enter the research. People who took an even number will enter intervention group and people who took an odd number will enter control group. The participants are unaware of the allocation of study groups. Members of intervention group will receive care based on the family nursing model. Nursing intervention to improve family functioning and social support is carried out during 12 one-hour sessions. The control group will not receive any intervention and only the research variables will be measured in them.
Settings and conduct
Location of the study will be Shariati and Gharazi hospitals in Isfahan. Data analyzer is unaware of allocation of study groups. Members of intervention group will receive care based on family nursing model. Nursing intervention to improve family functioning and social support is carried out during 12 one-hour sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of osteoporosis by attending physician
Not having other concurrent orthopedic diseases
To have the physical ability to perform daily activities
Family's consent for the researcher to visit their home
Not having psychiatric disorders
Exclusion criteria:
Participation of patients and families in other similar care programs at the same time as this study
Intervention groups
Intervention group: Members of this group will receive care based on family nursing model.
Control group: they will not receive any intervention and only research variables will be measured in them.
Main outcome variables
adherence to treatment; daily activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240305061174N1
Registration date:2024-04-20, 1403/02/01
Registration timing:registered_while_recruiting
Last update:2024-04-20, 1403/02/01
Update count:0
Registration date
2024-04-20, 1403/02/01
Registrant information
Name
Mohammad Mostafa Asiyabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 920 290 3900
Email address
mostafaasiyabi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-07-04, 1403/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care based on the family nursing model on treatment compliance and activity of daily living (ADL) in osteoporosis patients
Public title
The effect of care based on the family nursing model on treatment compliance and activity of daily living (ADL) in osteoporosis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of osteoporosis by the attending physician
Not having other concurrent orthopedic diseases
To have the physical ability to perform daily activities
The family's consent for the researcher to visit their home
Not having psychiatric disorders
Exclusion criteria:
Participation of patients and families in other similar care programs at the same time as this study
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the people who enter the study will randomly pick a ball from a container with the numbers 1 to 40 inside. The picked number is the code of the person in the study. People who took an even number will enter the intervention group and people who took an odd number will enter the control group. Therefore, the simple randomization method will be applied at this stage. There is no allocation concealment. The participants are unaware of the allocation of study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer is unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Isfahan (Khorasgan) Branch
Street address
University Blvd, Arqavanieh, Jey Street.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2024-03-03, 1402/12/13
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.414
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M80
ICD-10 code description
Osteoporosis with current pathological fracture
Primary outcomes
1
Description
Treatment adherence score in Modanloo questionnaire
Timepoint
Before the start of the intervention and 7 days after the end of the intervention
Method of measurement
Modanloo's adherence questionnaire
2
Description
Activity of daily living score in Habibi questionnaire
Timepoint
Before the start of the intervention and 7 days after the end of the intervention
Method of measurement
Habibi's activity of daily living questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The members of the intervention group will receive care based on the family nursing model. To perform this care, the method used in Sabola et al.'s study will be used. Nursing intervention to improve family functioning and social support is carried out during 12 one-hour sessions. These items will be examined and taught: examination of residence and recent stressors, examination of patient and family needs, training in theoretical understanding of family roles, medical information training, communication training, medication and movement training, social - Psychology support training and study of education by the family.
Category
Rehabilitation
2
Description
Control group: will not receive any intervention and only the research variables will be measured in them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan's Gharazi Hospital
Full name of responsible person
Hamidreza Golkar
Street address
Gharazi Street
City
Isfahan
Province
Isfehan
Postal code
8196973133
Phone
+98 31 3491 2000
Email
gharazi.hos@tamin.ir
2
Recruitment center
Name of recruitment center
Isfahan's Shariati Hospital
Full name of responsible person
Hamid Moghare Dehkordi
Street address
Chaharbagh bala blvd.
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
shariati.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Payam Najafi
Street address
University Blvd, Arqavanieh, Jey Street.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Mostafa Asiabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Blvd, Arqavanieh, Jey Street.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Exynos1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mostafa Asiabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Blvd, Arqavanieh, Jey Street.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Exynos1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mostafa Asiabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Blvd, Arqavanieh, Jey Street.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Exynos1@gmail.com
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
Only part of the data, such as information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It will be possible to use the data only for future studies.مر
From where data/document is obtainable
Refer to the researcher via email:
Exynos1@gmail.com
What processes are involved for a request to access data/document
The desired data will be accessible at most one week after sending the request via email.