Investigating The effect of a supportive educational program based on COPE model on the burden of care and quality of life in family care provider with Ischemic Stroke dischared of intensive care units of selected hospitals
To determine the score of care burden and quality of life in patient caregivers
Design
Clinical trial with a pre-test and post-test design in the form of two test and control groups and three stages (before, immediately and one month after the intervention) on 32 caregivers of patients with ischemic stroke and random allocation of samples using a table of numbers Computerized randomness
Settings and conduct
The intervention group will participate in a training-support course that will be conducted based on the coop model and based on needs assessment, in the form of 3 face-to-face sessions and two telephone sessions. The participants, caregivers of patients with ischemic stroke discharged from medical training centers affiliated to Isfahan University of Medical Sciences, will complete the questionnaires in the pre-test and post-test stages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Caregiver's age between 18 and 60 years.
Caregiver should not be a member of the health team.
DO not participate in another similar study at the same time.
Do not take care of two patients at the same time.
One month has passed since providing care.
Does not have a chronic disease.
Intervention groups
For the people who entered the intervention group, the problem solving method is explained based on the COPE model (increasing creativity, optimism, planning and specialized information). A booklet about common problems and necessary training is given to the caregiver and he is asked to choose a problem and teach how to use the model and booklet to solve the problem.
The control group only receives hospital training at the time of discharge.
Main outcome variables
Quality of life of caregivers of patients;
Care burden of caregivers of patients
General information
Reason for update
Acronym
COPE
IRCT registration information
IRCT registration number:IRCT20230303057597N1
Registration date:2023-10-25, 1402/08/03
Registration timing:retrospective
Last update:2023-10-25, 1402/08/03
Update count:0
Registration date
2023-10-25, 1402/08/03
Registrant information
Name
Masoumeh Raeesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3462 5336
Email address
raeesi63@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The effect of a supportive educational program based on COPE model on the burden of care and quality of life in family care provider with Ischemic Stroke dischared of intensive care units of selected hospitals
Public title
Effect of a supportive educational program on the burden of care and quality of life in family care provider
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Family caregivers of people with ischemic stroke
One month has passed since the time of providing care
Exclusion criteria:
Caregiver's age shouldn't be below 18 years and above 60 years
Not to participate in another similar study at the same time
Take care of two patients at the same time
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are selected in an easy continuous method from among the family caregivers of patients with ischemic cerebral stroke discharged from the intensive care unit in need of family care who meet the entry criteria for the study. Then they are randomly assigned to two control and test groups. In order to randomly assign the samples using a computerized random number table, a code is first assigned to each of the participants, then the first 32 codes are assigned to the control group and the next 32 codes are assigned to the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of m
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8193761925
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.127
Health conditions studied
1
Description of health condition studied
Ischemic Stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Care burden score
Timepoint
Measurement of care burden score before and immediately and one month after the intervention
Method of measurement
Zarit Caregiver Burden Scale
2
Description
The overall quality of life score before and immediately and one month after the intervention
Timepoint
Measuring the overall quality of life score before and immediately and one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the people who entered the intervention group, first a face-to-face meeting will be held at the hospital, where the method of solving the problem will be explained based on the Koop model. In the creativity component, care problems are taught from different perspectives to develop new strategies to solve them. (For example, "I will be creative in my patient's daily activities.") In optimism, families should have a positive but realistic attitude toward the problem-solving process. As much as possible in planning, they convey realistic optimism to the patient (eg, "I believe that daily activities can be done.") In planning, reasonable care goals are set and steps are taken. What is necessary to achieve those goals is determined in advance (for example, "I plan my patient's daily activities so that he can also be present in the crowd."). In professional information, families are taught what nonprofessionals need to know about the nature of the problem, when to seek professional help, and what family caregivers can do on their own to cope (eg, I use available resources). I will use). Then a booklet about common problems and necessary training is given to the caregiver and he is asked to choose a problem and teach how to use the model and booklet to solve the problem. In this meeting, educational needs assessment is done by the individual and the family. The educational content and goals in the first session include: greetings, expressing goals and needs assessment, familiarizing the person with the disease, signs and symptoms, and at the end of the first session, an agreement is made about a phone call with him. Based on the patient's condition, face-to-face sessions will be between one and two hours, and phone sessions will last between 15 and 20 minutes.Three days after the first session, the researcher made a reminder phone call to the caregiver and read the booklet and asked questions about the implementation of the care according to the training program and agreed on a face-to-face meeting with the caregiver at the hospital to review the results of the previous session/fix the problems. be madeIn the second face-to-face meeting on the 16th day, the process is reviewed again and the caregiver is discussed about another problem and the use of models and booklets, and the time of the next phone call with him to teach new educational concepts is determined.In the next phone call, which will be made two days later, the carer's questions will be answered and he will be encouraged to use the model, and the time to complete the questionnaire will be agreed with him one month after the start of the program.The control group only receives hospital training at the time of discharge and follow-ups from the relevant hospital's health education unit, and after one month, the questionnaire is completed for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Medical and Education Center
Full name of responsible person
Mehrdad noroozi
Street address
Al-Zahra Medical Education Center, Sofe St
City
Isfahan
Province
Isfehan
Postal code
8193861925
Phone
+98 913 227 1978
Email
raeesi63@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza askari
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 227 1978
Email
eaeesi63@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?