Protocol summary

Summary
This randomized controlled trial study aims to determine whether continuing cardiac rehabilitation programs at home has positive effects on self efficacy of the participants’ in comparison with control group or not. Study population includes all patients refer to ambulatory rehabilitation center 1.5 months after being discharged from hospital. Patients are in the groups of post CABG, MI or PTCA. Base line assessments including Echocardiography and ETT will be done by cardiologist. Inclusion criteria are age between 30-75 years, lack of mobility limiting disease, mental disorders, untreated heart failure, uncontrolled arrhythmias and stable angina. Patients not willing to participate in study or having developed any cardiovascular or musculoskeletal problems during rehabilitation program will be excluded from the study. Sample size is estimated 80 people, 40 in each group. Both groups will receive routine cardiac rehabilitation program in rehabilitation centre. In addition, the intervention group receives education and practical training in various rehabilitation measures along with home visits of a community health nurse in follow-up period. General Self Efficacy Scale (GSES) is used to assess self efficacy between the two groups at baseline and on follow-up period. Collected data from General Self Efficacy Scale will be analyzed using Minitab software and repeated measurement analysis model.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106086747N1
Registration date: 2011-06-12, 1390/03/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-12, 1390/03/22
Registrant information
Name
Sarieh Poortaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1657 9130
Email address
spoortaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2009-02-01, 1387/11/13
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of home-based cardiac rehabilitation program on self efficacy of patients referred to cardiac rehabilitation centre.
Public title
Cardiac rehabilitation and self efficacy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Aage between 30-75 years; lack of mobility limiting disease; mental disorders ; untreated heart failure; uncontrolled arrhythmias and stable angina. Exclusion criteria: Not willing to participate in ; having developed any cardiovascular or musculoskeletal problems during rehabilitation program
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Regional Ethic Committee Office
Street address
Alzahra Research center, Alzahra hospital, South Artesh St, Baghshomal crossing, Tabriz, Iran
City
Tabriz
Postal code
5138665793
Approval date
2009-02-01, 1387/11/13
Ethics committee reference number
51664

Health conditions studied

1

Description of health condition studied
Cardiac rehabilitation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
General self-efficacy
Timepoint
Monthly
Method of measurement
General self efficacy questionnare

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group will receive routine cardiac rehabilitation program in rehabilitation centre. In addition, education and practical training in various rehabilitation measures along with two home visits ( at the end of first and second month after finishing the program)of a community health nurse in follow-up period. General Self Efficacy Scale (GSES) is used to assess self efficacy at baseline and on follow-up period.
Category
Lifestyle

2

Description
Control group will receive routine cardiac rehabilitation program in rehabilitation centre. and General Self Efficacy Scale (GSES) will be completed by them at begining and end of the rehabilitation program. in addition at the end of first and second month after finishing the program GSES will be given to complete.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid madani cardiac rehsbilitation centre
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice challenger for research
Street address
Vice challenger for research, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sarieh Poortaghi
Position
MSc in public health nursing
Other areas of specialty/work
Street address
Alzahra Research center, Alzahra hospital, South Artesh St, Baghshomal crossing, Tabriz, Iran
City
Tabriz
Postal code
5138665793
Phone
+98 41 1657 9130
Fax
Email
spoortaghi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sarieh Poortaghi
Position
MSc in public health nursing
Other areas of specialty/work
Street address
Alzahra Research center, Alzahra hospital, South Artesh St, Baghshomal crossing, Tabriz, Iran
City
Tabriz
Postal code
5138665793
Phone
+98 41 1657 9130
Fax
Email
spoortaghi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sarieh Poortaghi
Position
Msc in public health nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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