The effect of the implemention of the care program on the continuous care model on activities of daily living and sleep quality of patients with epilepsy
General purpose:
Determining the impact of the implementation of a care program based on the continuous care model on daily life activities and sleep quality of patients with epilepsy referred to Shahrekord medical centers in 1401-1402
Design
The clinical trial has two intervention and control groups, randomized and conducted on 62 patients.
Settings and conduct
Patients with grand mal epilepsy referred to Shahrekord medical centers affiliated to Shahrekord University of Medical Sciences were allocated to intervention and control groups by sampling method based on the purpose of selection and then by card selection method. In this study, the follow-up care model in patients with epilepsy is performed according to the following steps:
The first stage is familiarization, which is to express the goals and explain the stages of the model to get to know the nurse, the patient and his family. The second stage is sensitization, which emphasizes the need for follow-up and continuity of care and its non-interruption, the third stage is follow-up and control, which follows how to continue care in order to improve health, the fourth stage is evaluation, which we check to what extent it meets the goals. We have achieved care and the effect of the trainings is carried out. During the intervention, only routine interventions are provided to the control group.
Participants/Inclusion and exclusion criteria
1- The diagnosis of grand mal epilepsy in patients based on clinical symptoms, the results of abnormal electroencephalogram (EEG) waves and the doctor's diagnosis. 2- The age range of patients is over 18 years old (58). 3-Having normal hearing, vision and mental strength to enable him to communicate.
Intervention groups
In this study, interventions are performed based on the continuous care model, which has four stages.
Main outcome variables
Activities of daily living and Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221220056879N1
Registration date:2023-10-12, 1402/07/20
Registration timing:retrospective
Last update:2023-10-12, 1402/07/20
Update count:0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Hamidreza Amirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 041 7981
Email address
h.r.amirhosseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2023-08-23, 1402/06/01
Trial completion date
empty
Scientific title
The effect of the implemention of the care program on the continuous care model on activities of daily living and sleep quality of patients with epilepsy
Public title
The effect of the implemention of the care program on the continuous care model on activities of daily living and sleep quality of patients with epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis of grand mal epilepsy in patients based on clinical symptoms, the results of abnormal electroencephalogram (EEG) waves and the doctor's diagnosis.
The age range of patients is over 18 years old.
Having normal hearing, vision and mental strength to enable him to communicate.
To have the ability and literacy to read and write.
Exclusion criteria:
patients who do not want to continue attending the study for any reason.
Creating an acute and serious illness, problem or stress that somehow prevents them from continuing interventions during the intervention period.
Absent more than one session in training sessions.
Incompletely filling out questionnaires.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with grand mal epilepsy referred to Shahrekord medical centers affiliated to Shahrekord University of Medical Sciences are allocated to intervention and control groups by sampling method based on the purpose of selection and then by card selection method. In this way, 31 cards related to the intervention group and 31 cards related to the control group are placed in the envelope, and then the clients are asked to randomly pick one of them, and in this way, the client is assigned to the group listed on the card.
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 Shahrekord University of Medical Sciences
Street address
No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street
City
Ramhormoz
Province
Khouzestan
Postal code
6381675178
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.SKUMS.REC.1401.213
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
Score of activities of daily living in Barthel questionnaire
Timepoint
The score of activities of daily living in patients with epilepsy before, immediately and two months after the intervention.
Method of measurement
Questionnaire (score 0 to 100)
2
Description
Sleep quality score in the Petersburg questionnaire
Timepoint
Sleep quality score in patients with epilepsy before, immediately and two months after the intervention
Method of measurement
Questionnaire (score 0 to 21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Demographic data questionnaire, Persian version of Barthel's daily life activities questionnaire and Petersburg Sleep Quality Questionnaire (PSQI) whose validity and reliability have been proven in Iran are completed by both groups and the intervention work For the group, the test begins, which takes place in four steps, including familiarization, sensitization, follow-up, and evaluation, and is carried out for eight weeks. The content of the training program takes place in five sessions. Familiarization and sensitization stages are carried out for three weeks and control and evaluation stages for five weeks. Questionnaires are completed by the intervention group before, immediately after and two months after the intervention.
Category
Lifestyle
2
Description
Control group: they only receive routine training in the first phase of familiarization, and this includes how to deal with the patient and his family in an emergency when a seizure attack occurs, and questionnaires in the three phases before, immediately after the intervention and two months after The intervention is completed by the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital in Shahrekord
Full name of responsible person
Hamidreza Amirhosseini
Street address
No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street
City
Ramhormoz
Province
Khouzestan
Postal code
6381675178
Phone
+98 61 4352 8649
Email
www.h.r.amirhosseini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeesi
Street address
No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street
City
Ramhormoz
Province
Khouzestan
Postal code
6381675178
Phone
+98 938 941 1200
Email
h.r.amirhosseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamidreza Amirhosseini
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street
City
Ramhormoz
Province
Khouzestan
Postal code
6381675178
Phone
+98 61 4352 8649
Email
www.h.r.amirhosseini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamidreza Amirhosseini
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street
City
Ramhormoz
Province
Khouzestan
Postal code
6381675178
Phone
+98 61 4352 8649
Email
www.h.r.amirhosseini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamidreza Amirhosseini
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street
City
Ramhormoz
Province
Khouzestan
Postal code
6381675178
Phone
+98 61 4352 8649
Email
www.h.r.amirhosseini@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The release of raw data has no logical justification except for a data bank suitable for analysis.
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access starts 6 months after the results are printed.
To whom data/document is available
All researchers have permission to access the data.
Under which criteria data/document could be used
The data will be entered in SPSS version 19 statistical software and will be analyzed using descriptive and analytical statistical tests.
What processes are involved for a request to access data/document
1_ The applicant should apply 2_ Refer to the university's proposal and permits 3_ If we are allowed to release the documents, ask for his email address and phone number 4_ We will hand over the documents to him with an undertaking that he will not use the documents unethically.