Protocol summary

Summary
Objective: The effect of follow-up care and collaborative care on quality of life in patients with coronary artery disease in selected military hospitals in Tehran Study design: Randomized  Inclusion criteria: Age 18 to 65 years; Lack of mental illness known; The ability to communicate in Persian; Have at least read and write; A family member willing to cooperate with the medical team Exclusion criteria: Lack of desire to continue cooperation in the study at any time of the study; death The study population included patients with a diagnosis of acute coronary syndrome have been bed ridden in ccus of NAJA Vali-Asr and AJA 502 hospitals and have the conditions of entering the study Sample size: 87 Two groups for collaborative care model and follow-up model and a control group. Intervention time: 20-04-2016 to 22-07-2016 Study outcome:Improve the quality of life in the heart patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041627405N1
Registration date: 2016-05-04, 1395/02/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-04, 1395/02/15
Registrant information
Name
Halime Zare Shorakie
Name of organization / entity
Nursing Faculty of AJA University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2233 5425
Email address
786halimezare@gmail.com
Recruitment status
Recruitment complete
Funding source
 AJA University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of partnership care and continuous care on quality of life in the coronary artery disease patients bed ridden in the chosen military hospital in Tehran
Public title
Investigate the effect of Nursing care models on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: - Age 18 to 65 years - Lack of mental illness known - The ability to communicate in Persian - Have at least read and write - A family member willing to cooperate with the medical team Exclusion criteria: - Lack of desire to continue cooperation in the study at any time of the study - death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 87
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
AJA Medical Science University
Street address
Fatemi street, Etemadzade street, next to AJA 501 hospital
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.AJAUMS.REC.1394.41

Health conditions studied

1

Description of health condition studied
coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
quality of life
Timepoint
before intervention, 1 month & 2 months & 3 months after intervention
Method of measurement
Nattingham quality of life questionnaire

Secondary outcomes

1

Description
Heart health of clients
Timepoint
before intervention- 1 month, 2 months, 3 months after intervention
Method of measurement
A self-made questionnaire and measuring pulse, breathing, blood pressure

Intervention groups

1

Description
Intervention group 1: Implementation of a participatory model of nursing care for 3 months which the patients and their family members are taught
Category
Behavior

2

Description
intervention group 2: the implementation of the follow-up nursing care model that patients are trained, evaluation and follow-up for a period of 3 months after discharge.
Category
Behavior

3

Description
control group: No action
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
NAJA Vali-Asr Hospital
Full name of responsible person
Mr.Sheikhi
Street address
Vali-Asr street, Ahead of Mir Damad St. Yassami edge
City
Tehran

2

Recruitment center
Name of recruitment center
AJA 502 Hospital
Full name of responsible person
Mrs. Tehrani
Street address
Taleghani st. Bahar Shiraz intersection
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Mrs. Dr. Aliarie
Street address
Western Fatemi Street - Street Etemadzadeh
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA 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
Nursing Faculty of AJA
Full name of responsible person
Dr. Amir Hosein Pishgooie
Position
Assistant Professor, School of Nursing Aja
Other areas of specialty/work
Street address
Shariatie street, Kaj street, beside Khanevade hospital
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
apishgooie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing Faculty of AJA
Full name of responsible person
Amir Hosein Pishgooie
Position
PhD in Nursing
Other areas of specialty/work
Street address
Shariatie street, Kaj street, beside Khanevade hospital
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
apishgooie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing Faculty of AJA Medical science
Full name of responsible person
Halime Zare Shorakie
Position
master student of critical care nursing
Other areas of specialty/work
Street address
Shariatie st. Kaj st. beside Khanevade hospital
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
786halimezare@gmail.com
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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