In this clinical trial, purposive sampling method will be used. After ethical consideration and inclusion criteria, the samples will be divided into two groups and HbA1C testing is done in patients in the intervention group and the control. Then questionnaires of demographic and lifestyle information and self-efficacy for data collection (patients) will be completed in two groups and then will be collected. After that, family-centered empowerment model for the intervention group (patients and family members) within 5 to 7 meeting (almost six weeks) will be implemented. In the control group, education without the involvement of family will be provided for patients.
Gathered data by using SPSS 20 software, descriptive and inferential statistics will be analyzed. Upon completion of the study and report the results, in order moral considerations, empowerment model will be implemented in the control group, too.
General information
Acronym
ِDiabetic Patient
IRCT registration information
IRCT registration number:IRCT2017022832817N1
Registration date:2017-03-18, 1395/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-18, 1395/12/28
Registrant information
Name
Homeira Atashzadeh Shoorideh
Name of organization / entity
School of Medicine, SBMU
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 6171
Email address
h_atashzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on the life style, self-efficacy and HbA1C of diabetic patients in Lavasan center
Public title
Effect of family-centered empowerment model on the life style, self-efficacy and HbA1C of diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Have at least 6 months history of diabetes
2. Have HbA1C>7%
3. Ability to speech and have not any hearing or speech problem
4. Have at least literacy
5. Age 40-65
6. Have not any Psychological disease, dementia, mental or psychological problems, end stage of liver or kidney disease, cancer and CVA
7. No nurse or physician
8. Ability to participate in study and completion the questionnaire
9. Have a tendency to participate in study
10. Have medical record in Lavasan Center
Exclusion criteria:
1. No participation/involvement of patient or her/his active member of family in research
2. No tendency to complete of questionnaire
3. Participation of patient or her/his active member of family in other study during this research
4. Establish any disorder or disease which can be effect on this intervention
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Training process in intervention group consists of four stages: perceived threat (assess of knowledge, awareness, and ambiguities), troubleshooting / problem solving (defining problems and solutions, and problem solving), participation in training (training to the patient's family member provided by patient) and evaluation. In control group all of stages (without stage three [participation in training]) will be done. These sessions will be conducted in six weeks and the follow-up period will be done (in six weeks). The total of these steps is three months.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee in school of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway Tel : +98 21 23871
City
Tehran
Postal code
Approval date
2016-07-19, 1395/04/29
Ethics committee reference number
IR.SBMU.MSP.REC.1395.150
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
life style,
Timepoint
Pre intervention, immediately after intervention, 3 months after intervention
Method of measurement
questionnaire, Blood Test
2
Description
self-efficacy
Timepoint
Pre intervention, immediately after intervention, 3 months after intervention
Method of measurement
questionnaire
3
Description
HbA1C
Timepoint
Pre intervention, 3 months after intervention
Method of measurement
Blood Test
Secondary outcomes
empty
Intervention groups
1
Description
Training process in intervention group consists of four stages: perceived threat (assess of knowledge, awareness, and ambiguities), troubleshooting / problem solving (defining problems and solutions, and problem solving), participation in training (training to the patient's family member provided by patient) and evaluation.
Category
Lifestyle
2
Description
Training process in control group consists of three stages: perceived threat (assess of knowledge, awareness, and ambiguities), troubleshooting / problem solving (defining problems and solutions, and problem solving), and evaluation. In control group all of stages (without stage three [participation in training]) will be done.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Lavasan Center
Full name of responsible person
Dr. Homeira Atashzadeh-Shoorideh
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice-Chancellor in Research Affairs
Street address
Dr. Afshin Zarghi
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Shahnam Arshi
Position
PhD
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St., Chamran Highway
City
Tehran
Postal code
Phone
+98 21 23871
Fax
Email
sh.arshi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Shahnam Arshi
Position
PhD
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St., Chamran Highway
City
Tehran
Postal code
Phone
+98 21 23871
Fax
Email
sh.arshi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine, SBMU
Full name of responsible person
Homeira Atashzadeh-Shoorideh
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
h_atashzadeh@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)