Protocol summary

Summary
The aim of this study is to determine the effect of a comprehensive home-based cardiac rehabilitation intervention on health promotion of coronary heart disease patients. This study is a single blinded, randomized trial in which 240 patients with coronary heart disease will be enrolled in the Phase III cardiac rehabilitation. Exclusion criteria included unstable angina, dementia, and cardiac arrhythmia. Patients will be randomly allocated into two groups based on permuted blocks method. After the initial evaluation, the intervention group will receive consultation on physical activity, healthy diet, stress management, and smoking cessation by related specialists. Additionally, patients will be visited at the baseline, 10 days, one month, and three months after intervention by a cardiologist. Moreover, trained nurses will visit patients’ at home at the baseline, sixth and twelfth weeks after intervention. Participants will be also given a telephone number to share their possible problems with specialists. In contrast, control group will receive routine training before discharging from hospital. Primary outcomes (quality of life, psychological and smoking status, BMI, blood pressure, blood cholesterol level, and physical activity) will be measured 6 months after intervention. Secondary outcomes (CVD events and death rates due to cardiovascular reasons) will be measured a year after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022926820N1
Registration date: 2016-08-09, 1395/05/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-09, 1395/05/19
Registrant information
Name
Alireza Ansari Moghaddam
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5884
Email address
ar.ansarimoghadam@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Institute for Medical Research Development (NIMAD)
Expected recruitment start date
2016-07-09, 1395/04/19
Expected recruitment end date
2017-01-08, 1395/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on the effectiveness of a comprehensive home based cardiac rehabilitation intervention on the health promotion of patient with coronary heart disease
Public title
Home based cardiac rehabilitation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: having coronary heart disease. Exclusion criteria: dementia; unstable angina; cardiac arrhythmia's
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
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
National Institute for Medical Research Development (NIMAD)
Street address
National Institute for Medical Research Development (NIMAD) Between Gharib and Eskandari Ave., Azadi St., Tehran, Iran.
City
Tehran
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.NIMAD.REC. 1394.019

Health conditions studied

1

Description of health condition studied
Coronary heart disease
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
Quality of life
Timepoint
Before and 6 months after intervention
Method of measurement
Quality of life questionnaire for cardiac patients

2

Description
Depression
Timepoint
Before and 6 months after intervention
Method of measurement
Beck Depression Inventory

3

Description
Physical activity
Timepoint
Before and 6 months after intervention
Method of measurement
Godin Leisure Time Physical Activity Questionnaire

4

Description
Blood pressure
Timepoint
Before and 6 months after intervention
Method of measurement
Using mercury sphygmomanometer on millimeters of mercury scale

5

Description
BMI
Timepoint
Before and 6 months after intervention
Method of measurement
The person's weight in kilograms divided by the square of height in meters

6

Description
Lipid profile
Timepoint
Before and 6 months after intervention
Method of measurement
Using rlated laboratory kits

Secondary outcomes

1

Description
Recurrent cardiovascular events
Timepoint
A year after the intervention
Method of measurement
Individual medical records

2

Description
Mortality due to cardiovascular disease
Timepoint
A year after the intervention
Method of measurement
Individual medical records

Intervention groups

1

Description
Intervention group will be given three sessions of educational program (for half an hour each) on physical activity. Comparably, control group will receive routine training before discharge.
Category
Lifestyle

2

Description
Intervention group will be given three sessions of educational program (for half an hour each) on stress management. Comparably, control group will receive routine training before discharge.
Category
Lifestyle

3

Description
Intervention group will be given three sessions of educational program (for half an hour each) on healthy diet. Comparably, control group will receive routine training before discharge.
Category
Lifestyle

4

Description
Intervention group will be given three sessions of educational program (for half an hour each) on smoking cessation for current smokers. Comparably, control group will receive routine training before discharge.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam al-Anbia Hospital
Full name of responsible person
Mahmood Barahooi (Nurse)
Street address
Khatam al-Anbia Hospital, Jam-e Jam Blvd, Zahedan, Iran.
City
Zahedan

2

Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Hospital
Full name of responsible person
Shahrzad Saraband (Nurse)
Street address
Ali Ebne Abitaleb Hospital, Khalij-e-Fars Highway, Zahedan, Iran.
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Institute for Medical Research Development (NIMAD)
Full name of responsible person
Sayena Rafizadeh (Proposal Evaluation)
Street address
National Institute for Medical Research Development (NIMAD) Between Gharib and Eskandari Ave., Azadi St., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development (NIMAD)
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
Zahedan University of Medical Sciences
Full name of responsible person
Hassan Okatialiabad
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran.
City
Zahedan
Postal code
9816743175
Phone
+98 54 3329 5837
Fax
+98 54 3329 5837
Email
okati_h@yahoo.com
Web page address
http://beh.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hassan Okatialiabad
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran.
City
Zahedan
Postal code
9816743175
Phone
+98 54 3329 5837
Fax
+98 54 3329 5837
Email
okati_h@yahoo.com
Web page address
http://beh.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hassan Okatialiabad
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran.
City
Zahedan
Postal code
9816743175
Phone
+98 54 3329 5837
Fax
+98 54 3329 5837
Email
okati_h@yahoo.com
Web page address
http://beh.zaums.ac.ir

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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