Abstract
Objectives: Investigation of the effect of self-care training on the health quality of life among elderly with diabetes referring to Isfahan Diabetes Center in 2014.
Setting and design: A total of 64 elderly people will be selected using census sampling then subjects will be allocated to the two equal group, 32 subjects will be in experimental group and 32 subjects in control group, via randomized by computer.
Outcomes measurement: the intervention group will receive self-care training program designed for elderly with diabetes. The control group will receive routing care, then health quality of life will be measured and compared in the two groups, in the time before the intervention and after the intervention.
Major inclusion and exclusion criteria: In this study, all subjects over 60 years old diagnosed with Type II diabetes and using insulin to control blood sugar, will be included in the study, and elderly who do not have the ability to self-care training classes or are hospitalized or died during the study or immigrated will be excluded.
Intervention: The intervention group will receive six sessions of self-care training to the elderly included: lecture, group discussion and practical work in a form of slides and videos. Hemoglobin of the both groups will be measured before and after the intervention.
Variables of main outcome: The main variable is the health-related quality of life and will be measured through self-care training in elderly with diabetes.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015060122528N1
Registration date:2016-07-11, 1395/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Hojjatollah Mahdi
Name of organization / entity
University of Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3766 0394
Email address
ho.mahdi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Research funding was provided by the University of Welfare and Rehabilitation Sciences and Alzahra Diabetes Center
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of the effectiveness of self-care training on health-related quality of life among older adults with diabetes
Public title
Effectiveness of self-care training on quality of life among older adults with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 60 and older have; suffering from diabetes; are under treatment by a physician or medical group; physically have the ability to participate in the study; The patient has cognitive health; More than 5 years of diabetes they have; The use of insulin to control blood sugar; severe health complications such as blindness, amputation, heart problems, respiratory, cerebral and renal dialysis may not have.
Exclusion criteria: Opt out of the study during study; Failure to attend training sessions; hospitalization during the study; The use of psychotropic drugs and physical medicine (except blood glucose lowering drugs) that affect on blood sugar; migration or death
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
University of Welfare and Rehabilitation
Street address
University of Welfare and Rehabilitation Sciences, Koodakyar end, Daneshjoo B, Evin, Tehran
City
Tehran
Postal code
Approval date
2014-10-20, 1393/07/28
Ethics committee reference number
IR.USWR.REC.1393.241
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
VI
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Health-related quality of life
Timepoint
Pre-intervention and three month after intervention
Method of measurement
health status quality of life in elderly questionnaire, Hba1c test
Secondary outcomes
1
Description
HBA1C TEST
Timepoint
3 Months
Method of measurement
Colorimetric method
Intervention groups
1
Description
Intervention Group: self-care training in 6 sessions + HBA1C TEST