Determining the effect of peer support on treatment adherence, quality of life and health literacy of type 2 diabetic patients
Design
This clinical trial has a control group. It has been randomized and will be performed on 80 patients without blinding. Randomization is done using cards A and B.
Settings and conduct
The research community includes type 2 diabetic patients who refer to diabetes clinic on September 8 in Aligudarz city.After 3 days of diabetes training for patients, 80 people will be selected by convenience sampling and the samples will be randomly divided into two groups of intervention and control. Patients in the intervention group will again be randomly assigned to 4 groups under the same training for 3 months
Participants/Inclusion and exclusion criteria
eligible criteria: At least 6 months have passed since the doctor diagnosed them with type 2 diabetes,Be over 18 years old,Do not have a history of participating in educational programs in the field of diabetes during the past year,Have a desire to participate in the present study,Do not have cognitive problems,Do not have a physical disability,Do not need diabetic foot surgery,Do not have medical or related education
Not eligible criteria:The patient has physical problems that she is not able to take care of herself, Patients who do not wish to participate in the study.
Intervention groups
The intervention program will receive a diabetes training program from its counterparts .In addition to the usual care, the Regular care Control group participates in their 3-day care program.
Main outcome variables
HbA1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150525022406N2
Registration date:2020-07-18, 1399/04/28
Registration timing:retrospective
Last update:2020-07-18, 1399/04/28
Update count:0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
arezoo shahsavari
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 4332 4755
Email address
shahsavari.a@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-01, 1398/12/11
Expected recruitment end date
2020-04-07, 1399/01/19
Actual recruitment start date
2020-03-04, 1398/12/14
Actual recruitment end date
2020-05-08, 1399/02/19
Trial completion date
2020-08-25, 1399/06/04
Scientific title
The effect of peer support on adherence to treatment, quality of life and health literacy in patients with type 2 diabetes
Public title
The effect of peer support on adherence to treatment in patients with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months have passed since the doctor diagnosed them with type 2 diabetes
Be over 18 years old
Do not have a history of participating in educational programs in the field of diabetes during the past year
Have a desire to participate in the present study
Do not have cognitive problems
Do not have a physical disability
Do not need diabetic foot surgery
-Do not have medical or related education
It is possible to make a direct phone call with the patient
Exclusion criteria:
Do not want to participate in the study
The patient has physical problems that they are not able to take care of themselves
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided into intervention and control groups. In order to randomly assign participants in two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, participants are asked to take a card in order, then the samples will be placed in one of the intervention or control groups based on the removed card. In this way, all participants will have an equal chance to be in two groups.
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
School of pharmacy and Nursing & Midwifery-shahid Beheshti University of Medical Sciences
Before intervention , 3 months after the intervention
Method of measurement
Patient blood sample in the laboratory
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention , Immediately after the intervention, 3 months after the intervention
Method of measurement
Quality of life questionnaire
2
Description
Health literacy
Timepoint
Before intervention , 3 months after the intervention
Method of measurement
Questionnaire Health literacy (TOFHLA)
3
Description
Diabetes self care dimension
Timepoint
Before intervention , Immediately after the intervention, 3 months after the intervention
Method of measurement
Diabetes Self-Care Questionnaire
4
Description
Percieved Social Support(PRQ-85)
Timepoint
Before intervention , 3 months after the intervention
Method of measurement
Percieved Social Support Questionnair
5
Description
Body Mass Index
Timepoint
Before intervention , 3 months after the intervention
Method of measurement
Weight and height measurement
Intervention groups
1
Description
In this study, after identifying eligible individuals and obtaining informed consent for the first time, questionnaires of quality of life, adherence to treatment, health literacy, perceived social support were completed during the face-to-face interview and blood samples for HbA1c, height and Weight measurement will be done for each participant.Then, group training will be prepared for 3 days in order to match the basic information of the participants according to the latest current instructions of the Ministry of Health and after simplifying the concepts, it will be implemented. Questionnaires will be completed immediately after the end of the 3-day course and for the second time. Patients will then be randomly divided into intervention and control groups.The selection of peers will be done with the participation of health care providers present in the center, a checklist for assessing the ability of peers and face-to-face interviews with qualified individuals. The selected peers will then be trained. In addition to diabetes care knowledge, this training will include training specific skills needed by peers such as communication and problem solving skills. In the next stage, the participants of the intervention group will be randomly trained in one of the 4 groups. In order to randomize the cards A, B, C, D (10 cards each) will be prepared and the members of the intervention group will be asked to choose one after shuffling the cards. In this way, people will be randomly placed in one of the four peer training groups. By introducing peers to patients in each group, the peer support intervention program will begin for 3 months. In addition to the usual care program, this program will include a monthly group training session with a discussion approach and participation of all members (3 sessions in total), a monthly group exercise program session (3 sessions in total). In addition, according to the schedule, peers can call their patients during the agreed hours and talk to them about each patient's specific care issues. 3 months after the start of the intervention for the third time, the questionnaires will be completed for both intervention and control groups. Also, HbA1c and patients' BMI will be measured and recorded again.
Category
Lifestyle
2
Description
Control group: usually diabetes clinic care includes weekly visit of a nutritionist and general practitioner and training using pamphlets in the diabetes center. Individuals in this group will also receive 3 days of diabetes care training, similar to the intervention group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Aligudarz city specialized clinic on 17 September
Full name of responsible person
Sarlak Masomeh/Diabetes Nurse
Street address
Nourth Vali-Asr st
City
Aligudarz
Province
Lorestan
Postal code
6861716118
Phone
+98 66 4332 4755
Email
shahsavari_arezoo1397@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zarghi, Afshin.Vice- Chancellor in Research Affairs
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
Shahsavari, Arezoo
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Babaei Post Office, Shahrdari four-way
City
Aligudarz
Province
Lorestan
Postal code
6861617117
Phone
+98 66 4332 8642
Email
shahsavari_arezoo1397@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahsavari, Arezoo
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Babaei Post Office, Shahrdari four-way
City
Aligudarz
Province
Lorestan
Postal code
6861617117
Phone
009843328642
Email
shahsavari_arezoo1397@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahsavari.Arezoo
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Babaei Post Office, Shahrdari four-way
City
Aligudarz
Province
Lorestan
Postal code
6861617117
Phone
009843238642
Email
shahsavari_arezoo1397@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publication of the article The effect of peer support on the dependent variables of quality of life, adherence to treatment, perceived social support, glycosylated hemoglobin and body mass index
When the data will become available and for how long
Up to five years after sampling
To whom data/document is available
Supervisor and Research Consultants
Under which criteria data/document could be used
Only for the publication of scientific articles
From where data/document is obtainable
Deputy of Research, Shahid Beheshti School of Nursing and Midwifery,Tehran
What processes are involved for a request to access data/document
Written request to the research deputy of Shahid Beheshti School of Nursing and Midwifery, sent to the research deputy of the university and accept or reject the request