Assessing the Effectiveness of Integrated Psycho-Spiritual Care Package on Self-Efficacy, Self-Care and Health-Related Quality of Life in Adults with Type 2 Diabetes.
Determining the effect of an integrated psycho-spiritual care package on self-efficacy, self-care and health-related quality of life in adults with type 2 diabetes.
Design
Clinical trial with control and intervention group, before and after design, randomized with regular random method, on 118 patients.
Settings and conduct
Compilation of content, multi-stage sampling, the first face-to-face meeting and completion of the informed consent form and questionnaires, and the first blood test at the blood Sugar and Lipid Testing Unit of the Endocrine and Metabolism Research Institute, 18 training sessions on the web Application, face-to-face meeting and completion of questionnaires and blood tests immediately after the end of the intervention, face-to-face meeting and completion of questionnaires and blood tests 3 months after the end of the intervention, analysis of results
Participants/Inclusion and exclusion criteria
Individuals with type 2 diabetes and covered by comprehensive health service centers under the supervision of the Endocrine and Metabolism Research Institute of Shahid Beheshti University of Medical Sciences
They have not received psychological or spiritual care or treatment since the diagnosis of the disease.
HbA1C level above 6.5%.
At least 5 years have passed since the diagnosis of type 2 diabetes of the participants.
Intervention groups
The intervention group will receive the psycho-spiritual care package for 6 weeks, 18 training sessions, and the control group will receive only the usual health care.
Main outcome variables
Self-Efficacy, Self-Care, Health-Related Quality of Life and blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221013056164N1
Registration date:2022-11-15, 1401/08/24
Registration timing:prospective
Last update:2022-11-15, 1401/08/24
Update count:1
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Yasamin Geloumaki Robati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
y.g.robati1400@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effectiveness of Integrated Psycho-Spiritual Care Package on Self-Efficacy, Self-Care and Health-Related Quality of Life in Adults with Type 2 Diabetes.
Public title
Effectiveness of psycho-spiritual care package in adults with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with type 2 diabetes and covered by comprehensive health service centers under the supervision of the Endocrine and Metabolism Research Institute of Shahid Beheshti University of Medical Sciences
They have not received psychological or spiritual care or treatment since the diagnosis of the disease.
Do not suffer from severe mental illnesses such as psychotic disorders and memory disorders, PTSD or substance abuse.
HbA1C level above 6.5%.
At least 5 years have passed since the diagnosis of type 2 diabetes of the participants
Exclusion criteria:
Have severe mental, emotional and psychological disorders such as dementia
At the same time, suffer from debilitating diseases such as cancer, MS, stroke, end stages of liver and kidney diseases, etc.
Have vision and hearing problems
A pregnant woman with gestational diabetes
Have other specific types of diabetes.
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:
118
Randomization (investigator's opinion)
Randomized
Randomization description
After choosing the comprehensive health service center, in the available method; Sampling will be random. Based on the list of contact information extracted from the health records of samples that meet the criteria for entering the research from the data bank of the center, people will be randomly selected from the list and assigned to the control or intervention group and this work will continue until the completion of samples in each group. The first person to be assigned to the control or intervention group will be determined by lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study has 2 groups (control and intervention), during which the control group will not receive any intervention and the intervention will be done only for the intervention group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamek and Zarafshan, Quds town (west), Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-10-02, 1401/07/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.474
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Self-Efficacy
Timepoint
Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Diabetes Management Self-Efficacy Scale (DMSES)
2
Description
Self-Care
Timepoint
Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Self-Care of Diabetes Inventory (SCODI), Blood sugar registration form
3
Description
Health-Related Quality of Life
Timepoint
Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
Method of measurement
World Health Organization quality of life questionnaire - Brief version (WHOQoL-BREF)
Secondary outcomes
1
Description
fasting blood sugar
Timepoint
Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
Method of measurement
blood test
2
Description
Glycosylated hemoglobin (HbA1c)
Timepoint
Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
Method of measurement
blood test
Intervention groups
1
Description
Intervention group: will receive 18 short training sessions three times a week (for 6 weeks) in a web application. In order to compile educational content the library search method, review the latest evidence and the opinion of experts in this field, as well as the opinion of several patients (at least 10 people with different education levels and social classes, different duration and severity of diabetes and from each two genders) will be used and finally after compiling the content, the validity of the content will be confirmed by examining the opinion of 5 experts and 10 patients (with different education levels and social classes, different duration and severity of diabetes and from both sexes). The educational content will be uploaded in the "Self-Care Web Application" of the Department of Management and Psychiatric Nursing, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. Various methods of producing electronic educational content such as multimedia, video, podcast, interactive text and sth like that will be used according to the educational purpose. The content creation method for each of the 18 educational goals will be approved by at least 2 experts in the field of electronic education, and the agreement coefficient above 70% will be used to select the method. In case of disagreement, the opinion of a third person will be used. In order to follow up, answer questions and further interactions, the WhatsApp group (according to the country's internet conditions and the possibility of accessing WhatsApp, another messenger may be used) will be used as a support group consisting of all intervention people.
Category
Other
2
Description
Control group: no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran lipid and Glucose center
Full name of responsible person
Amir Abbas Momenan
Street address
Shahid Nahavandi Street, Air Force Si Meter Street, Tehran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
90
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasamin Geloumaki Robati
Position
MSc of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery, Intersection of Niayesh Highway (Ayatollah Hashmi Rafsanjani) and Vali Asr (AJ) Street, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Gelumaki.Robati98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Foroozan Atashzadeh Shoorideh
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Intersection of Niayesh Highway (Ayatollah Hashmi Rafsanjani) and Vali Asr (AJ) Street, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Forooata@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasamin Geloumaki Robati
Position
MSc of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery, Intersection of Niayesh Highway (Ayatollah Hashmi Rafsanjani) and Vali Asr (AJ) Street, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Gelumaki.Robati98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
It can be shared after making people unidentifiable
When the data will become available and for how long
Start access one year after the results are published
To whom data/document is available
People working in academic and scientific institutions
Under which criteria data/document could be used
Subject to the agreement of Shahid Beheshti University of Medical Sciences
From where data/document is obtainable
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Dr. Ateshzadeh's office
What processes are involved for a request to access data/document
Written and official request to the Research Vice-Chancellor of the Faculty of Nursing and Midwifery