The effects of Cardiac Rehabilitation on Quality of Life and Self-care management based on Orem’s theory in Elderly with CHF referring to Shiraz hospitals- 2013
This study is a quasi-experimental and Double-blind study. Goal of the study: to determine the effect of Cardiac Rehabilitation on Quality of Life and Self-care management based on Orem’s theory in Elderly with CHF referring to Shiraz hospitals. Sampling methods: samples (90 patients) will randomly assign to two groups: case & control with the blocking method. After obtaining informed consent, questionnaires completed by researcher before intervention. Inclusion criteria are willingness to participate in the study and fluent in speaking and understanding Persian; age above 60 years and ejection fraction below 40% with a confirmed diagnosis of CHF. Exclusion criteria are weakness of the extremities; cognitive or psychological abnormalities; death or recurrence of illnesses; doesn’t participate more than two sessions in cardiac rehabilitation program. Each group will followed for two months (no intervention for control group their care will be based on hospital’s routine), for the cases intervention will be based on Orem’s theory, they participate in cardiac rehabilitation program and at the same time researcher will teach them by face to face method and give them a booklet containing all information they needed. After intervention (2 months) the QOL & self-care questionnaires will complete by two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306297531N2
Registration date:2013-09-13, 1392/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-13, 1392/06/22
Registrant information
Name
Iran Jahanbin
Name of organization / entity
University of Medical Sciences Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 917 313 7399
Email address
jahanbii@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research affairs, Shiraz University of Medical Sciences, Shiraz, Iran.
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Cardiac Rehabilitation on Quality of Life and Self-care management based on Orem’s theory in Elderly with CHF referring to Shiraz hospitals- 2013
Public title
The effects of cardiac rehabilitation on elderly with congestive heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients with congestive heart failure admitted in hospitals affiliated to Shiraz University of Medical Sciences that diagnosis of disease are confirmed by cardiologists & based on heart failure classification (NYHA) in class 1 to 3 with left ventricular ejection fraction less than 40 %.
2) Physical therapist or cardiologist allowed them for participates in rehabilitation program.
3) Must be aged 60 years old or older.
4) The patient doesn’t participate in the same study in the same time.
5) The ability to communicate & Perception in Persian.
6) The patient doesn’t have other known problems such as orthopedic disorders, physical or cognitive disorders that limited physical or learning activities.
7) Willingness to participate in the intervention, and written informed consent form is completed.
Exclusion criteria:
1) Lack of willingness to cooperate to participate in the study.
2) Absence in more than 2sessions in rehabilitation programs.
3) Worsening of the patient's condition for continued participation in the study, so that makes it impossible.
4) Cognitive and mental diseases.
5) Extremities weakness whatever the reason, any disorder or defect so that the desired activities could be limited.
6) Death of the patient, Recurrence or hospitalization.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Boulevard, Shiraz, Iran.
City
Shiraz
Postal code
71348-14336
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
92/56660
Health conditions studied
1
Description of health condition studied
Congestive heart failure
ICD-10 code
150.0
ICD-10 code description
Congestive heart diseaseRight ventricular failure (secondary to left heart failure)
Primary outcomes
1
Description
Quality of life
Timepoint
Before interventions, after the end of interventions
Method of measurement
SF36 QOL questionnaire
2
Description
Self Care Ability
Timepoint
Befor interventions,After the end of interventions
Method of measurement
EHFScB Questionnaire (Self Care Scale)
Secondary outcomes
empty
Intervention groups
1
Description
The case groups participate in cardiac rehabilitation therapy in 8 weeks consecutive, 3 sessions in each week that takes 1 hour. At the same time, in each session the researcher give them necessary education based on primary needs evaluation & Orem’s theory by face to face training then a booklet that Prepared by researcher containing the definition of heart failure , signs & symptoms ,causes of disease ,risk factors & the ways of control, treatment, medication, pain management and non-pharmacological management of heart failure, how to control body weight, diet, smoking cessation , traveling, social interaction, activity and rest, exercise, when consult their doctor or nurse, identifying sign & symptoms of worsening condition and the need to visit physician, proper use of assistive devices and healthy lifestyle.
Category
Rehabilitation
2
Description
Control group: they will receive only routine care after discharge from the hospital or outpatient departments.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Faqihi hospital
Full name of responsible person
Dr. Key noosh Homayouni
Street address
Karim Khan Zand Boulevard, Next to Medical School,Shiraz,Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Vice Chancellor for Research affairs, Shiraz University of Medical Science, Zand Boulevard, Shiraz, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Rasti
Position
Geriatric Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Hazrat Fatemeh, Namazi Square, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 78 2452 7455
Fax
Email
rasti_ma@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Iran Jahanbin
Position
Faculty instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery Hazrat Fatemeh, Namazi Square, Shiraz, Iran.
City
Shiraz
Postal code
13119–71936
Phone
+98 71 1647 4251
Fax
+98 71 1647 4252
Email
jahanbii@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Rasti
Position
Geriatric Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Hazrat Fatemeh, Shiraz, Iran.
City
Shiraz
Postal code
Phone
Fax
Email
rasti_ma@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)