Protocol summary

Summary
This study aimed to determine the effect of continuous care model on the post angioplasty patients quality of life. This clinical trial study was performed in Bou Ali Sina hospital of Qazvin in 2012 on 93 candidates of angioplasty which were divided in to two experience and control groups with random allocations. Inclusion criteria include Having coronary artery disease, For the first time,candidates of angioplasty . Exclusion criteria include Patients with severe stress, the patient is not able and not willing to cooperate. Continuous care model was applied on experience group for a period of two months . For data collection demographic checklist and “MacNew quality of life “ questionnaire in three stages were used The result was confirmed the positive effect of applying continuous care model on the score of the post angioplasty patients quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100814943N1
Registration date: 2013-12-04, 1392/09/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Zahra Arjeini
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1379 4442
Email address
zarjini@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research - Qazvin University of Medical Science
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous care model on quality of life of patient after coronary angioplasty.
Public title
The effect of continuous care model on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. Have coronary artery disease. 2. For the first time,candidates of angioplasty . 3. Have the ability to communicate. 4. Have a willingness to cooperate Exclusion criteria: 1. The patient is not able to cooperate. 2. The patient is not willing to cooperate. 3. Patients with severe stress(death of first degree relatives , New debilitating illness)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2013-03-10, 1391/12/20
Ethics committee reference number
7062 /28/20

Health conditions studied

1

Description of health condition studied
patient after angioplasty
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft

Primary outcomes

1

Description
Quality of life
Timepoint
Before the intervention, one month after the intervention and two months after intervention
Method of measurement
MacNew standard questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Apply two months of continuous caremodel onthe intervention group
Category
Other

2

Description
Certain actions are not performed on the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bou Ali Sina Hospital
Full name of responsible person
Zahra Arjeini
Street address
Bou Ali Street, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Qazvin University of Medical Science
Full name of responsible person
Dr. Saeed Asef Zadeh
Street address
Vice-chancellor for research, Qazvin University of Medical Sciences, Bahonar Bla, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Qazvin University of Medical Science
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
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Arjeini
Position
student
Other areas of specialty/work
Street address
Nursing Faculty, Shahid Bahonar blv, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1379 4442
Fax
Email
z.arjeini@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Arjeini
Position
student
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blv, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1379 4442
Fax
Email
z.arjeini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Scenices
Full name of responsible person
Zahra Arjeini
Position
Student
Other areas of specialty/work
Street address
Qazvin University of Medical Scenices, Shahid Bahonar blv, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 213338034
Fax
Email
zarjini@qums.ac.ir
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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