Investigating the effect of self-care education based on the family-centered empowerment model on self-management, self-care, and readmission rates of patients with diabetic ketoacidosis
The aim of this study was to determine the effect of self-care education with a family-centered approach on self-management, self-care, and readmission rates of patients with diabetic ketoacidosis admitted to Seyed al-Shohaday Hospital in Jahrom in 2026.
Design
This study is a clinical trial and has a control group and is for 136 patients, 68 in each group. The sampling method in this study will be a random block method, in which samples that are similar in terms of one or more specific characteristics are placed in a block, which controls the effects of these factors.
Settings and conduct
This study is to be conducted at Seyed al-Shohaday Hospital in Jahrom city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of diabetes according to the opinion of an internist or endocrinologist
Having an active companion and a relative of the patient to participate in the implementation of the intervention who is fully aware of his disease and is concerned about his treatment.
Having a minimum level of literacy, to the point of being able to read and understand the content in the uploaded clips.
Aware of time and place, able to understand Persian
Exclusion criteria:
Having advanced malignant diseases such as types of cancer, chronic kidney disease, and advanced heart disease
Failure to attend the training session
Failing to feel unwell during the training period
Unwillingness to continue cooperation
Patient death
Intervention groups
Educational sessions will begin for the families of patients in the intervention group. The researcher will provide three days of face-to-face education to the companions of patients in the intervention group about diabetes and its important complication, ketoacidosis, and strategies for preventing and dealing with it. Each session will last approximately half an hour.
Main outcome variables
Self-management, self-care, readmission rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210114050037N4
Registration date:2026-03-26, 1405/01/06
Registration timing:prospective
Last update:2026-03-26, 1405/01/06
Update count:0
Registration date
2026-03-26, 1405/01/06
Registrant information
Name
َAli asghar Rahmanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 3628
Email address
lynurse8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-04, 1405/01/15
Expected recruitment end date
2026-05-21, 1405/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care education based on the family-centered empowerment model on self-management, self-care, and readmission rates of patients with diabetic ketoacidosis
Public title
Investigating the effect of self-care education based on the family-centered empowerment model on self-management, self-care, and readmission rates of patients with diabetic keto acidosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetes according to the opinion of an internist or endocrinologist
Having an active companion and a close relative of the patient to participate in the implementation of the intervention, who is fully aware of her illness and is concerned about her treatment.
Having a minimum level of literacy to be able to read and understand the content in the uploaded clips.
Aware of time and place, able to understand Persian
Exclusion criteria:
Having advanced malignant diseases such as various types of cancer, chronic kidney disease, and advanced heart disease
Failure to attend training session
His/her feeling unwell during the training period
Unwillingness to continue cooperation
death of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sample size, since patients enter the study gradually, the block randomization method will be used to assign participants to the control or intervention groups. In this method, considering the sample size of 136participants and 22 participants per block, we will need 6 blocks. All possible block permutations include AABB, ABAB, ABBA, BAAB, BABA, and BBAA. Then, a number from 1 to 6 will be randomly selected, and allocation will begin with that block. The subsequent blocks will also be selected and completed in the same manner.
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 the Faculty of Medical Sciences, Garash
Street address
Gerash City, Imam Hussein Blvd., Daneshjoo Blvd., Gerash Faculty of Medical Sciences
City
Gerash
Province
Fars
Postal code
7441758666
Approval date
2026-02-25, 1404/12/06
Ethics committee reference number
IR.GERUMS.REC.1404.023
Health conditions studied
1
Description of health condition studied
Diabetic Keto Acidosis
ICD-10 code
E10.10
ICD-10 code description
Type 1 diabetes mellitus with ketoacidosis without coma
Primary outcomes
1
Description
The effect of self-care training based on the family-centered empowerment model
Timepoint
Measuring the level of self-management before the start of the intervention and one month after the intervention.
Method of measurement
Diabetes self-management questionnaire
2
Description
Measuring self-care
Timepoint
Before the start of the intervention and one month after the intervention
Method of measurement
Self-care Activities Summary Questionnaire
3
Description
Readmission rate
Timepoint
Before and one month after the intervention
Method of measurement
Demographic information questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Families and patients in this group are impacted by self-care education regarding diabetic ketoacidosis.In this way, the researcher provides face-to-face education for the companions of patients in the intervention group for three days about diabetes and its important complication, ketoacidosis, and strategies for preventing and dealing with it, with each session lasting approximately half an hour. After each session, the researcher asks the patient's companion to give his or her feedback on the information provided and to clarify any ambiguity. In addition, the patient's companion is asked to convey the information to the patient when he or she has enough energy and patience.The educational content of these three sessions is as follows: Session 1: Introduction to diabetes, its types, and proper diet adherence Session 2: How to use and store insulin (with an educational video) and, if taking oral diabetes medications, related training Session 3: Self-monitoring of blood sugar and familiarization with the symptoms of low or high blood sugar and strategies for dealing with it It should be noted that the content of the educational sessions will be collected from the book by Bruner and Suddarth, reputable websites and articles related to diabetes. After the intervention, patients and family members were given three months to take care of themselves and keep their disease under control based on the skills acquired in the educational sessions.
Category
Other
2
Description
Control group: Patients in this group will only undergo routine ward training.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al-Shohaday Hospital, Jahrom City
Full name of responsible person
Ali asghar Rahmanian kushkaki
Street address
Dr. Abdolreza Rahmanian Street, Ostad Motahari Blvd., Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
7415854139
Phone
+98 71 5414 2000
Email
info@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Street address
Imam Hossein (AS) Blvd., Daneshjoo Blvd., Garash Faculty of Medical Sciences
City
Gerash
Province
Fars
Postal code
7441758666
Phone
+98 71 5244 8101
Email
info@gerums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gerash 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
Gerash University of Medical Sciences
Full name of responsible person
Ali asghar Rahmanian Kushkaki
Position
Instractor
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Imam Hossein (AS) Blvd., Daneshjoo Blvd., Garash Faculty of Medical Sciences
City
Gerash
Province
Fars
Postal code
7441758666
Phone
+98 71 5244 8101
Email
info@gerums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Ali asghar Rahmanian Kushkaki
Position
Instractor
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Imam Hossein (AS) Blvd., Daneshjoo Blvd., Garash Faculty of Medical Sciences
City
Gerash
Province
Fars
Postal code
7441758666
Phone
+98 71 5244 8101
Email
Lynurse8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Aliasghar Rahmanian Kushkaki
Position
Instractor
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Imam Hossein (AS) Blvd., Daneshjoo Blvd., Garash Faculty of Medical Sciences
City
Gerash
Province
Fars
Postal code
7441758666
Phone
+98 71 5244 8101
Email
Lynurse8@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
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available