Objectives: This survey was aimed to assess the effect of educational intervention on self-care behaviors among patients with diabetes: an application of PRECEDE model. Design: A randomized clinical trial study was conducted. Setting and conduct: This survey was conducted on 106 patients with type 2 diabetes who had active records in the diabetes clinics (just two clinics) in the Iranian city of Gorgan. Participants: Inclusion main criterion was having type 2 diabetes more than two years, and exclusion criterion was treatment with insulin. Intervention: Patients were randomly assigned in the control (53 patients) and intervention (53 patients) arms. Main outcome measures: Self-care behaviors, glycosylated hemoglobin, body mass index and constructs of PRECEDE model.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112817736N9
Registration date:2017-01-20, 1395/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Seyed Kamaladdin Mirkarimi
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 1553 2872
Email address
k.mirkarimi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
International Campus of Tehran University
Expected recruitment start date
2015-09-05, 1394/06/14
Expected recruitment end date
2016-04-02, 1395/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Educational Intervention on Self-Care Behaviors among Patients with Diabetes: an Application of PRECEDE Model
Public title
Self-Care Behaviors among Patients with Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having type 2 diabetes more than two years; inclines to participate in the study; age less than 60 years; and lack of debilitating disease. Exclusion criteria: Treatment by insulin; disable to exercise (such as walking); gestational diabetes; cognitive disorders that may interfere with completing the questionnaire.
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences of International Campus
Street address
Tehran
City
Tehran
Postal code
Approval date
2015-03-21, 1394/01/01
Ethics committee reference number
9223489001
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Glycated hemoglobin (HbA1C)
Timepoint
Pre-intervention, 1, 3 and 6 month after intervention
Method of measurement
Blood test
Secondary outcomes
1
Description
Self-care behavior
Timepoint
Pre-intervention, 1, 3 and 6 month after intervention
Method of measurement
A standardized self-care behavior questionnaire
Intervention groups
1
Description
Control group: Patients in the control group were received the routine education that usually provided in the diabetes clinics. Totally, patients were received a maximum education of 7-10 (the mean time of these sessions were usually 20-30 minutes). Education in this arm was provided by a general physician.
Category
Prevention
2
Description
Intervention group: All content of intervention group were presented by the workshop. Additionally, lecture, enquiry, group discussion and snow balling techniques were also used during the workshop. Sessions were held for four weeks (two hours per week) in the diabetes clinic in Gorgan city. Approximately, 25 patients took part in the each session. In the final of sessions, patients were provided by brochures and necessary guidance. To increase the reinforcing factors and family supports, patients were asked to participate in the sessions with one of their family members. In final, a single session was held for the members of patient's family to avoid ambiguity, as well. Education in this group was delivered by two persons including a general physician and by a specialist in health education and promotion.