The aim of the study is investigation of effect of family-centered empowerment model in diabetic elderly who are at risk of falling. Inclusion criteria consisted of 60 years old Elderly and older And completing screening questionnaire and earning score of 7 or higher and exclusion criteria is unwillingness of elderly and members of his family to empowerment program.30 elderly have been considered as the experimental group and the control group is the same number as control group.
For experimental group, family-centered empowerment model has been done in eight-sessions of 45 minute for 1.5 months in four steps: perceived threat (severity and sensitivity), problem solving, educational participation and evaluation. Usual care and a training session are conducted for the control group. The test is conducted after a week, is tracked after three months. The primary outcome after the intervention is the empowerment score average.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061728502N1
Registration date:2016-09-09, 1395/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
Sakine Parvareshan
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
info@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences of Babol
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination the effect of family-centered empowerment model on elderlies with diabetes who are at falling risk in Bojnourd city
Public title
The effect of family-centered empowerment model on elderlies with diabetes who are at falling risk in Bojnourd city
Purpose
Prevention
Inclusion/Exclusion criteria
elderly Inclusion criteria: Willingness to participate in research;60 years old elderly and older, The definitive diagnosis of type 2 diabetes with at least six months experience (tested and approved according to the doctor);having a case in related doctor's office; without having hearing and cognitive disorders based on AMT scale; reading and writing ability, Living with a family and residents of the city; Willing and able to make phone calls to elderly and active family members; Without having debilitating complications of diabetes such as blindness, low vision, joint disease (arthritis, Rheumatoid arthritis);Completing screening questionnaire of falling and earning score of 7 or higher; Inclusion criteria of patients' families: active Family members who want to participate in its research and collaboration; reading and writing ability of active members (a family member; wife or husband, Daughter or a relative or close relative), A person who has the constant care of the elderly and elderly is comfortable with him, Exclusion criteria for this study: Unwillingness to continuing the corporate (the patient with family) in the empowerment program and Completing research tools, Nervous system such as Parkinson's disease and paralysis defects and musculoskeletal disorders of the patient, passing Diabetes Education courses by the patient and family
Age
From 60 years old to 90 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
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
Babol University of Medical Sciences
Street address
-Babol University of Medical Sciences, Gangafrooz Street, Babol
City
Babol
Postal code
47745-47176
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
mubabol.rec. 1395.79
Health conditions studied
1
Description of health condition studied
diabet
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
fall
Timepoint
1 month
Method of measurement
Screening Questionnaire fall
Secondary outcomes
1
Description
Family-centered empowerment aspects, including the perceived threat (perceived severity, perceived susceptibility), problem solving, educational participation and evaluation methods.
Timepoint
Before the intervention, the empowerment questionnaire has been given . Then, for 1.5 months empowerment model has been done in 8 sessions of 45 minutes. One week and three months after the empowerment program, the questionnaire will be given again.
Method of measurement
questionnaire of family-centered empowerment
Intervention groups
1
Description
For groups, family-centered empowerment model based on the four-step threat perceived self-efficacy, educational participation and evaluation should be
Category
Prevention
2
Description
For routine care control group and a training session was conducted.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinologist's Office
Full name of responsible person
Mohsen Salimifar
Street address
North Khorasan, Bojnurd, north Shariati St, Hekmati Av,physicians bulding, second floor
City
Bojnoord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Gangafrooz Street, Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
9542222
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
North Khorasan University of Medical Sciences
Full name of responsible person
Sakine Parvareshan
Position
Bachelor of Nursing, operating room manager, master of science student of nursing elderly
Other areas of specialty/work
Street address
Bojnurd, Takhti stadum, Kalate Av 1/2, NO12
City
Bojnurd
Postal code
Phone
+98 58 3272 2145
Fax
Email
afsane_parvareshan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Abbas Shamsalinia
Position
PhD
Other areas of specialty/work
Street address
Ramsar School of Nursing and Midwifery Fatemeh, Zahra
City
Ramsar
Postal code
47745-47176
Phone
+98 11 5522 5151
Fax
+98 112290181
Email
abbasshamsalinia@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Sakine parvareshan
Position
Bachelor of Nursing, operating room manager, student of master of science of eldery nursing
Other areas of specialty/work
Street address
Bojnurd, Takhti stadum, Kalate Av 1/2, NO12
City
Bojnoord
Postal code
47745-47176
Phone
+98 58 3272 2145
Fax
Email
afsane_parvareshan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)