Protocol summary

Study aim
- Determining the effect of family-oriented empowerment program on acceptance of diabetes and self-management in patients with type 2 diabetes
Design
The clinical trial has a control and intervention group. Control and intervention groups are determined in a randomized block fashion. The second phase will be performed on 60 patients. The sequence of random allocation and the list of blocks will be obtained by a statistical consultant with the help of R software.
Settings and conduct
This study is conducted in the diabetes clinic during four group training sessions on patients with type 2 diabetes and active family members. This training is done using a special booklet prepared by the researcher, using PowerPoint program and short educational videos. Then, after the completion of the educational sessions, the patients will be monitored using Iranian messengers for 6 weeks and their questions and doubts will be resolved. During this period, patients will be contacted by phone once a week.
Participants/Inclusion and exclusion criteria
Patients aged 25-60 who have medical records to confirm diabetes and have minimum literacy to fill out forms and communicate with mobile phones.
Intervention groups
The intervention group in this study are people with type 2 diabetes who participated in the educational class together with an active family member. The control group is also a group that is present in the study under the same conditions as the intervention group, but uses routine clinic training.
Main outcome variables
The main variables of this study are the family-oriented empowerment program; acceptance of diabetes; diabetes self-management; Patients with type 2 diabetes.

General information

Reason for update
Acronym
DASM
IRCT registration information
IRCT registration number: IRCT20240624062246N1
Registration date: 2024-07-16, 1403/04/26
Registration timing: prospective

Last update: 2024-07-16, 1403/04/26
Update count: 0
Registration date
2024-07-16, 1403/04/26
Registrant information
Name
Nastaran Amani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3220 7638
Email address
nastaranamani982@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the impact of family-centered empowerment interventions on patients' acceptance and self-management skills in type 2 diabetes
Public title
Investigating the effect of family-centered empowerment program on acceptance and self-management of patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- The age range of patients is 25-60 years - Having a medical record to confirm type 2 diabetes - Access and ability to use mobile phones to communicate and coordinate training sessions - Ability to communicate in Farsi language and minimum literacy to fill the relevant forms - Internet and mobile phone access
Exclusion criteria:
Patients who have auditory, visual and tactile disorders or are unable to speak Persian. - People who do not have medical records to confirm diabetes. - Participants who are in the age group of children and teenagers.
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, random block sampling will be done in two intervention and control groups. The sequence of random allocation and the list of blocks will be obtained by the statistical consultant and with the help of R software. At first, after obtaining the necessary permits and referring to the research environment, the participants will be available and according to the entry criteria and then After obtaining informed consent, they enter the research. Then, according to blocks of four, each patient was randomly assigned to group A (intervention) or group B (control group). For example, after randomly selecting a block such as the BABA block, patients will be randomly assigned to the control, intervention, control and intervention groups, and the next patients in the AABB group will be allocated to the intervention, intervention, control and control groups. The number of people assigned to the groups will be equal. In this research, in addition to random allocation, sequence concealment will also be done. For this purpose, first a random sequence was created, then based on the size of the research sample, a number of envelopes are prepared and each of the created random sequences is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the numbering will be done in the same order on the outer surface of the envelopes. Finally, the lids of the envelopes are glued and they will be placed in a box respectively. At the time of registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. People will be assigned to the desired group in the order of their entry into the study and randomly through randomized blocks.
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 Faculty of Pharmacy and Midwifery Nursing, Shahid Beheshti University of Medical
Street address
Tehran, Vali Asr Street, intersection of Ayat Ah... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.002

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E00-E90
ICD-10 code description
غدد درون ریز، تغذیه و بیماری‌های متابولیک (گواتر، قند خون یا دیابت، مشکلات وزن بدن و چاق و لاغری، رشد)

Primary outcomes

1

Description
Acceptance of diabetes
Timepoint
before the intervention and immediately after the intervention and 6 weeks after the intervention
Method of measurement
Diabetic acceptance questionnaire translated by Najafi Qazaljeh et al

2

Description
Diabetes self-management
Timepoint
before the intervention and immediately after the intervention and 6 weeks after the intervention
Method of measurement
Diabetes Self-Management Questionnaire Schmitt et al

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group consists of 30 patients with type 2 diabetes, who were selected according to the entry and exit criteria. In this study, the family-centered empowerment program was conducted in the form of four training sessions using PowerPoint and short training videos based on The information in the booklet produced by the researcher is provided to the participants of the intervention group and after the training sessions for 6 weeks, the patients asked their questions to the researcher in Iranian messaging groups and cleared their doubts. they do . During this period, clients will be contacted once a week for 10-15 minutes.
Category
Other

2

Description
Control group: The control group includes 30 patients with type 2 diabetes who were included in the study according to the inclusion and exclusion criteria. In this study, the control group will only receive the routine training of the diabetes clinic, and at the end of the study, according to the ethical principles, the diabetes education booklet will be provided to the patients.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital Diabetes Clinic
Full name of responsible person
Nastaran Amani
Street address
Semnan, Shahroud, Imam St., end of Baghzindan 28 meters, Imam Hossein (AS) Hospital
City
Shahrood
Province
Semnan
Postal code
۳۶۱۶۹۵۱۸۳۵
Phone
+98 23 3234 2000
Email
imamhosein@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Borhani
Street address
Tehran, Valiasr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
sbmuf@sbmu.ac.ir
Grant name
Grant code / Reference number
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Amani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nastaranamani982@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Amani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nastaranamani982@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Amani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nastaranamani982@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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