Protocol summary

Study aim
Determining the effect of an intervention program based on the Coop Care Model on resilience, health literacy level, understanding of the disease, and quality of life of family caregivers of elderly people with type 2 diabetes
Design
A single-blind, randomized, controlled clinical trial on 90 caregivers of elderly people with type 2 diabetes. The card methodis used for randomization.
Settings and conduct
1- The study will be conducted in health centers in Shahrekord city. 2- The study will be conducted on 90 caregivers of elderly people with type 2 diabetes. 3- Blinding is done on patients and their clinical caregivers, in such a way that until the end of the study, only the project administrator was aware of the caregiver groups, and the caregivers and patients themselves were not aware of their group type at all.
Participants/Inclusion and exclusion criteria
1- Willingness to participate in the study 2- Caregiver age over 18 years and under 65 years 3- Not caring for members of the health team 4- Ability to read and write in Persian 5- Self-declared that he/she does not have a known psychiatric disorder 6- The person is designated as the primary caregiver by the patient 7- The patient under the care of the elderly has type 2 diabetes
Intervention groups
Intervention group: In this study, a six-session program is carried out over a period of one month. These sessions are conducted in nine groups of five people, with two sessions in Shahrekord city health centers for 60 minutes and four sessions in the form of telephone calls for 30 minutes, along with follow-ups through WhatsApp groups over a period of one month by the researcher. Control group: no intervention was performed in this group.
Main outcome variables
Resilience, health literacy level, understanding of illness, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181122041720N4
Registration date: 2025-03-27, 1404/01/07
Registration timing: prospective

Last update: 2025-03-27, 1404/01/07
Update count: 0
Registration date
2025-03-27, 1404/01/07
Registrant information
Name
Shirin Madadkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 2382
Email address
shirinmadadkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an intervention program based on the family-centered model on the level of health literacy, understanding of the disease and the quality of life of family caregivers of the elderly with type 2 diabetes
Public title
The impact of the Coop care model on family caregivers of elderly diabetics
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in research. Be careful not to be a member of the health team Must be able to read and write in Persian. Do not simultaneously care for someone with another chronic illness. A person is designated by the patient as the primary caregiver. The patient under elderly care has type 2 diabetes. The caregiver must be over 18 years of age and under 65 years of age. Self-declares that he/she does not have a known psychiatric disorder
Exclusion criteria:
Participate in a similar training program
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Ninty caregivers of patients with type 2 diabetes who were eligible for the study are randomly assigned (by card method) to the experimental and control groups, so that 45 cards with number one and 45 cards Number two will be placed in a package in an envelope. And on the day of random division of research units, caregivers will be asked to choose a card. People who belong to number one are in the test group. And the people assigned to number two will be in the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
The people in the intervention and control groups are not introduced to each other at all before, during, and after the intervention, and they do not meet each other until the end of the study, so they do not know which group the caregiver is in. Rather, the project administrator is only informed of which caregivers are in which group until the end of the study. Only people in the intervention group will be given the necessary supplementary materials and the necessary arrangements for holding the meetings in the WhatsApp groups, while these materials and arrangements will not be informed to the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Shahrekord Branch
Street address
Islamic Azad University, Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Approval date
2025-03-17, 1403/12/27
Ethics committee reference number
IR.IAU.SHK.REC.1403.402

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Resilience
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Connor and Davidson Resilience Questionnaire (CD-RISC)

2

Description
Health literacy
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
TOFLA Health Literacy Questionnaire (TOFHLA)

3

Description
Illness Perception (IPQ-R)
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Illness Perception Questionnaire (IPQ-R)

4

Description
Minnesota Quality of Life
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Minnesota Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Caregivers in the intervention group will participate in 6 training sessions designed based on the COOP model (reference). These sessions will be conducted by the researcher in nine groups of five people, with two sessions in the health centers of Shahrekord for 60 minutes and four sessions in the form of telephone calls for 30 minutes, along with follow-ups through WhatsApp groups over a period of one month. The scheduling of these sessions will be done in agreement with the researcher and the caregivers. In these sessions, the three main problems of each caregiver in relation to patient care, such as the patient's activity level, strategies for improving resilience, and other issues, will be examined based on the COOP model. In-person sessions, lecture techniques, question and answer, educational images, and educational booklets will be used according to the needs of the patients' caregivers.
Category
Other

2

Description
Control group: Control group: In the control group, caregivers were provided with the necessary care and training, and no intervention was performed.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord County Health Center
Full name of responsible person
Shirin Madadkar Dahkordi
Street address
Shahrekord, Shahid Bahonar Street - Next to Imam Khomeini's (RA) Prayer Room
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815689067
Phone
+98 38 3222 4489
Email
shirinmadadkar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshid Kheiri
Street address
Shahrekord - Rahmatieh - Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1001
Email
shahrekord@iauece.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Shirin Madadkar Dehkordi
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord - Rahmatieh - Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1001
Email
shirinmadadkar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar Dehkordi
Position
University faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord - Rahmatieh - Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1001
Email
shirinmadadkar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar Dehkordi
Position
University faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord - Rahmatieh - Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1001
Email
shirinmadadkar@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
Undecided - It is not yet known if there will be 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
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