Purpose: The effect of health-related lifestyle self-management intervention on health promotion behaviors in patients with ischemic heart disease referred to Ekbatan Hospital in 2015. design study: a randomized, single-center, two-group semi-experimental before-after study. inclusion criteria: Patients with a diagnosis of ischemic heart disease is admitted in the Ekbatan Hospital in Hamedan; patient have at least one risk factors including hyperlipidemia, hypertension, obesity,limited physical activity and inappropriate diet; patient does not have other specific diseases (renal, respiratory, endocrine and orthopedic) with physician approval; The patient does not have mobility problems. Exclusion criteria: patient have major concomitant diseases, such as stroke and cancer that are influence in recovering. Sample size: 92. intervention study: health-related lifestyle self-management program (HELM). intervention time: 8 weeks. the primary outcome or consequences of the study: Compliance with health-promoting lifestyle in heart patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061422712N1
Registration date:2015-07-12, 1394/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-12, 1394/04/21
Registrant information
Name
Maryam Rajabi
Name of organization / entity
School of Nursing and Midwifery, Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38388464
Email address
m.rajabi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanceller for Research and Tecnology of Hamedan University of Medical Scinces
Expected recruitment start date
2015-06-26, 1394/04/05
Expected recruitment end date
2015-10-27, 1394/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of health-related lifestyle self-management intervention on health promotion behaviors in patients with ischemic heart disease
Public title
The effect of self-management on health promotion in cardiac patients
Purpose
Supportive
Inclusion/Exclusion criteria
Iinclusion criteria: Patients with a diagnosis of ischemic heart disease is admitted in the Ekbatan Hospital in Hamedan; patient have at least one risk factors including hyperlipidemia, hypertension, obesity,limited physical activity and inappropriate diet; patient does not have other specific diseases (renal, respiratory, endocrine and orthopedic) with physician approval; The patient does not have mobility problems. Exclusion criteria: patient have major concomitant diseases, such as stroke and cancer that are influence in recovering.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Hamedan University of Medical Sciences Ethics Committee
Street address
Hamedan University of Medical Sciences, Pazhuhesh Crossroads, Hamedan
City
Hamedan
Postal code
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.UMSHA.REC.1394.77
Health conditions studied
1
Description of health condition studied
ischemic heart disease
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
Health promoting behaviors
Timepoint
Before the intervention and at least 6 weeks after the intervention
Method of measurement
health promotion lifestyle questionnaire
Secondary outcomes
1
Description
Waist circumference
Timepoint
Before the intervention and at least 6 weeks after the intervention
Method of measurement
Handy meter
2
Description
blood pressure
Timepoint
Before the intervention and at least 6 weeks after the intervention
Method of measurement
mercurial pressure indicator
3
Description
body mass index
Timepoint
Before the intervention and at least 6 weeks after the intervention
Method of measurement
scale weight and meter
Intervention groups
1
Description
Intervention groups: health-related lifestyle, self-management intervention (HELM) use for at least six weeks. The main components include eight areas: goal setting, bibliotherapy, giving feedback to the patient about the risk factors associated with the disease according to tests and the physical condition of the patient, team building and communication with the physician, call (three telephone support), interview, the visual cue (fridge magnet) and a health diary for self monitoring.
Category
Lifestyle
2
Description
The control group consists of patients who received the usual care patients.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Haspital
Full name of responsible person
Doctor Mohammad Mehdi Esmaeili
Street address
Ekbatan Haspital, Taleghani street, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller for Research and Tecnology of Hamedan University of Medical Scinces
Full name of responsible person
Docter Saeed Bashirian
Street address
Hamedan University of Medical Sciences, Pazhuhesh crossroad, Hamedan .
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for Research and Tecnology of Hamedan University of Medical Scinces
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
Hamedan University of Medical Sciences
Full name of responsible person
Roya Amini
Position
MSc. of Nursing / Advisor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Pazhuhesh Crossroad, Hamedan .
City
Hamedan
Postal code
Phone
+91 83150740
Fax
Email
aminiroy@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Hamedan University of Medical Sciences
Full name of responsible person
Roya Amini
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences, Pazhuhesh Crossroads, Hamedan
City
Hamedan
Postal code
Phone
+91 83150740
Fax
Email
aminiroy@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, University of Medical Sciences
Full name of responsible person
Maryam Rajabi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Pazhuhesh Crossroad, Hamedan
City
Hamedan
Postal code
Phone
00
Fax
Email
m.rajabi@edu.umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)