A clinical trial on the effect of teaching versus non-teaching of supportive and obstructive behaviors to family caregivers on family behavior and self-care of patients with type 2 diabetes
This study investigates the effect of teaching supportive and obstructive behaviors to family caregivers on family behavior and self-care of patients with type 2 diabetes. The study will be performed in the Diabetes Clinic of Birjand. Sixty patients with type 2 diabetes will be recruited via convenience sampling method. Major inclusion criteria comprised of obtaining maximally half total score on Self-Care Activities measure and on Family Behavior Checklist in the two subscales of supportive (less than 18) and obstructive (over 14) behaviors; living with family members; aged 30 to 60 years., etc. Family care-givers will be selected via convenience sampling method and according to the opinion of the diabetic patient. The caregivers will be randomly allocated into control (n=30) and intervention (n=30) groups through permutation blocks. For the intervention group, supportive and obstructive behavior training program will be provided in 7 sessions through lecture, Q & A, group discussion and movies.Additionally, there will be telephone follow-up for 2 months to respond to questions and provide consultation to the primary caregivers. The control group receives only the routine program of the Diabetes Center. Finally, after two months from the last intervention session, Self-Care Activities measure and on Family Behavior Checklist will be completed in both groups. Comparison of the results will show the effect of the intervention on family behavior and self-care of patients with type 2 diabetes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053017756N15
Registration date:2017-07-04, 1396/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-04, 1396/04/13
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effect of teaching versus non-teaching of supportive and obstructive behaviors to family caregivers on family behavior and self-care of patients with type 2 diabetes
Public title
The effect of teaching supportive and obstructive behaviors to family caregivers on family behavior and self-care of patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for patients: Type 2 diabetes; obtaining maximally half total score on Self-Care Activities measure and on Family Behavior Checklist in the two subscales of supportive (less than 18) and obstructive (over 14) behaviors; living with family members; time passed at least one year from diagnosis of diabetes; aged 30 to 60 years; having a record in the diabetes clinic of Birjand; receiving medical therapy (tablets or insulin); informed consent to participate; lack of any physical, mental and cognitive barriers for self-care behaviors.
Exclusion criteria for the patients: lack of desire to continue to participate; occurrence of circumstances whereby understanding and support of family is influenced, such as mental illness, depression, and drug addiction; developing complications from diabetes such as kidney failure and blindness.
Inclusion criteria for family care-givers: Informed consent to participate; no cognitive, emotional and physical barriers to perform supportive and communicative behavior; residing with the patient in the same place; undertaking the main task of caring
Exclusion criteria for caregivers: developing cognitive, emotional and physical disorders impeding their support and communication; unwillingness to continue participation.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
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 Gonabad University of Medical Sciences
Street address
Vice-chancellery for Research, Gonabad University of Medical Sciences, Imam Khomaini St.,
City
Gonabad
Postal code
Approval date
2016-07-29, 1395/05/08
Ethics committee reference number
IR.GMU.REC.1395.54
Health conditions studied
1
Description of health condition studied
Diabetes Type 2
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Family Behavior
Timepoint
Before intervention and 2 months after intervention is finished
Method of measurement
Family Behavior Checklist by Schafer et al.
2
Description
Self-care behavior
Timepoint
Before intervention and 2 months after intervention is finished
Method of measurement
Self-Care Activities (SDSCA) Measure by Toobert et al.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group will receive supportive and obstructive behavior training program in 7 sessions through lecture, Q & A, group discussion, and movies. There will also be telephone follow-up for 2 months to respond to questions and provide consultation for the primary caregivers. After two months from the last intervention session, Self-Care Activities measure and Family Behavior Checklist will be completed in both groups.
Category
Behavior
2
Description
Control group: The control group receives only the routine program of Birjand-based Diabetes Center. After two months from the last interventional session, Self-Care Activities measure and on Family Behavior Checklist will be completed in both groups.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand Diabetes Center
Full name of responsible person
Dr Majid Shayesteh
Street address
Shirin Street,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Education and Research of Gonabad University of Medical Sciences
Full name of responsible person
Effat Datigerdi
Street address
Gonabad University of Medical Sciences, Asiayi Street,
City
Gonabad,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Education and Research of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Effat Datigerdi
Position
Nursing Student
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
e.dastigerdi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Effat Datigerdi
Position
Nursing Student
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
e.dastigerdi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)