Determining the effect of early palliative care on the quality of life and self-care behaviors of patients with Dodge type diabetes
Design
Clinical trial with a control group, without blinding, randomized, on 100 patients
Settings and conduct
The people in the intervention group are given the necessary information about palliative care, the palliative care plan is given to the people, and its implementation is followed up.
Participants/Inclusion and exclusion criteria
inclusion criteria : Diagnosis of type 2 diabetes Having one of the complications of diabetes (diabetic foot ulcer, neuropathy, nephropathy, etc.) Access and ability to use mobile phones to coordinate meetings، Not suffering from other life-threatening chronic diseases such as cancer, heart failure, etc. Ability to communicate in Farsi Internet access
Exclusion criteria : Non-cooperation during intervention Partially deaf Cognitive and mental disorder
Intervention groups
In the intervention group, the necessary information about palliative care is given during group and individual meetings, and the palliative care program is designed based on the needs of each person, and the control group receives the usual care plan.
Main outcome variables
Quality of Life, Self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231107059976N1
Registration date:2023-12-29, 1402/10/08
Registration timing:registered_while_recruiting
Last update:2023-12-29, 1402/10/08
Update count:0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Zahra Gholizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3220 3966
Email address
gholizade.zahra.1278@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of early palliative care on quality of life and self-care behaviours in patient with type2 diabetes
Public title
The effect of early palliative care on quality of life and self-care behaviours in patient with type2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes
Access and ability to use mobile phones
Ability to communicate in Farsi
Access to internet
Exclusion criteria:
Non-cooperation during intervention
Suffering from other life-threatening chronic diseases such as cancer, heart failure, etc
Partially deaf
Cognitive and mental disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation law is used to allocate two groups. First, the sample size is determined, which becomes 100, then each sample is assigned a number from 1 to 100, and each number is recorded on paper and thrown into a lottery container, and group A is the test group and group B is the group Control is considered. Each paper is taken randomly and without replacement and placed in group A and then B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-11-05, 1402/08/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.418
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
(E10-E14)
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Quality of life score with Quality of life questionnaire for patients with diabetes
Timepoint
At the beginning of the study and 5 weeks after the end of the study
Method of measurement
Quality of life questionnaire for patients with diabetes
2
Description
The score of Self-care behaviors with the questionnaire of self-care behaviors of patients with diabetes
Timepoint
At the beginning of the study and 5 weeks after the end of the study
Method of measurement
Questionnaire of self-care behaviors of patients with diabetes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is held 4 sessions weekly, the first 2 sessions are in groups, people are divided into 5 groups of 10 people, and group training sessions will be held between 60 and 90 minutes, after the training, there will be time to answer the clients' questions and group discussion. Taken. Thus, in the first session, the concept of diabetes and its symptoms, consequences and risks, the concept of palliative care and palliative care in diabetes are discussed. In the second session, the control of symptoms in the field of diet, medication, exercise and movement will be discussed and the needs of people in these areas will be examined. . In the third session, symptom management will be discussed regarding symptom control, relaxation methods, nutritional recommendations, foot care, and the consequences of diabetes. The third and fourth session will be held individually, the fourth session will be about examining the patient's values and helping to make decisions about treatment and symptom control, and the care plan will be based on the needs of the client and his participation, with special attention to the symptoms. physical and psychosocial are regulated and the goals of care are determined, In the fifth session, the general review of life will be done by the researcher through the client's participation, and his needs will be determined in terms of improving the level of life in different areas. Then for 5 weeks follow-up will be done by the researcher to answer the questions and check the adherence to the care plan through text message or phone call.
Category
N/A
2
Description
Control group: Routine care is received during the study and After completing the study, the training files will be provided to the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Zahra Gholizadeh
Street address
Imam Khomeini Street
City
Shahrud
Province
Semnan
Postal code
3619611151
Phone
+98 23 3234 2000
Email
gholizade.zahra.1278@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Ghiasvandian
Street address
Nosrat St., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6693 3600
Email
gholizade.zahra.1278@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Gholizadeh
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golha street
City
Shahrud
Province
Semnan
Postal code
3615819413
Phone
+98 23 3220 3966
Email
gholizade.zahra.1278@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Gholizade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golha
City
Shahroud
Province
Semnan
Postal code
3615819413
Phone
+98 23 3220 3966
Fax
Email
gholizade.zahra.1278@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Gholizadeh
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golha street
City
Shahrud
Province
Semnan
Postal code
3615819413
Phone
+98 23 3220 3966
Email
gholizade.zahra.1278@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data related to the main outcomes of the study
When the data will become available and for how long
The access period starts six months after the publication of the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For scientific use for studies
From where data/document is obtainable
Gholizade.zahra.1278@gmail.com
What processes are involved for a request to access data/document
Send a letter with the title of study data request