Determining the effect of continuous care model on self-efficacy and resilience of hemodialysis patients
Design
A randomized clinical trial with a control group, randomly assigning people to two control and intervention groups using the block method, sample size of 74 people and 37 people for each group, continuous care model in the intervention group and routine care in the control group
Settings and conduct
The study will be conducted in a selected military hospital in Tehran.
How to conduct the study: Determining the study population - Obtaining written informed consent - Random assignment to two intervention and control groups - Preparing educational content - Completing resilience questionnaire (Connor-Davidson) and self-efficacy questionnaire (Sherer) in the intervention and control groups before Intervention - in the intervention group, implementing the continuous care model process (including 4 stages of familiarization, sensitization, control and evaluation) - completion of the resilience and self-efficacy questionnaire after the intervention and two months after the intervention - in the control group, routine care and Completing the resilience and self-efficacy questionnaire at the end of the first and third months - data collection and analysis
Participants/Inclusion and exclusion criteria
Hemodialysis history of more than one year
Age less than 60 years and more than 18 years
Not having psychiatric disorders
Willingness to participate in research
Literacy for reading and writing
Intervention groups
In the intervention group, the continuous care model process (including 4 stages of familiarization, sensitization, control and evaluation) will be done. In the control group, routine care will be done.
Main outcome variables
resilience, self-efficacy
General information
Reason for update
Acronym
الگوی مراقبت پیگیر بیماران همودیالیز
IRCT registration information
IRCT registration number:IRCT20231005059632N1
Registration date:2023-10-29, 1402/08/07
Registration timing:registered_while_recruiting
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
Masoome Moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 3573
Email address
m.moisavi58.nurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of continuous care model on self-efficacy and resilience of hemodialysis patients in a selected military hospital
Public title
The effect of continuous care model on self-efficacy and resilience of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis history of more than one year
Exclusion criteria:
People who do not attend at least two training sessions of the continue care model
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups through variable blocks. (If A: intervention group, B: control group, then there will be six different modes for blocks of 4: AABB, ABAB, ABBA, BBAA, BABA, BAAB, which can be written on paper and taken from the bag)
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 Aja University of Medical Sciences
Street address
Aja University of Medical Sciences, Etemadzadeh Street, Fatemi West Street, Tehran
City
Tehran
Province
Tehran
Postal code
1693717171
Approval date
2023-09-22, 1402/06/31
Ethics committee reference number
IR.AJAUMS.REC.1402.117
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
self-efficacy
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the intervention and two months after the intervention
Method of measurement
Sherer's self-efficacy questionnaire
2
Description
resilience
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the intervention and two months after the intervention
Method of measurement
Connor and Davidson's resilience questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The continuous care model will be implemented in 4 stages (familiarization stage, sensitization stage, control and evaluation stage) and for one month.
Category
Lifestyle
2
Description
Control group: routine care will be done and no intervention will be done for them.