Objective: provide simple administrative solutions in order to create attitudes and behavior in order of importance of life style in patient with heart failure.
Field of study: randomized, double-blind, placebo-uncontrolled, uni-center, one phase of clinical trial.
A) Study population: Patients with heart failure, referred to Taleghani Hospital.
Inclusion criteria: willingness to participate in the study; 18- 65 years old; without learning disorders such as Alzheimer disease; without attending similar training.
Exclusion criteria: reluctance to continue to participate in the study; irregular participation in training classes; Death of a patient.
Sample size: 70, with the possibility of sample loss.
B) Intervention study: The effect of the implementation of family-centered empowerment model on the quality of life in patients with heart failure.
C) The study period: from 21 May 2017 to 22 July 2017.
D) The primary outcome: the creation of a positive attitude about the importance of family empowerment to Improve the quality of care in heart failure patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902173850N2
Registration date:2017-06-03, 1396/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
Registrant information
Name
Sima Zohari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 9648
Email address
sima_zohari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2017-07-22, 1396/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the implementation of family-centered empowerment model on the quality of life in patients with heart failure
Public title
The effect of the implementation of family-centered empowerment model on the quality of life in patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; 18- 65 years old; without learning disorders such as Alzheimer disease; without attending similar training.
Exclusion criteria: reluctance to continue to participate in the study; irregular participation in training classes; Death of a patient.
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples by blocking Randomization were randomly placed in two groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of SHahid Beheshti University of Medical Sciences
Street address
SBUMS, Arabi Ave, Yaman Ave, CHamran Highway, Tehran
City
Tehran
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.SBMU.PHNM.1395.650
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
150
ICD-10 code description
Heart failure
Primary outcomes
1
Description
The quality of life in patient with heart failure
Timepoint
The questionnaire immediately after the intervention and a month and a half after it is completed by samples of two experimental and control groups
Method of measurement
The quality of life questionnaire of minnesota
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: training classes to improve quality of life for patients in the three domains of cognitive, performance and mental health during the 5 to 7 sessions of training runs and then the samples immediately after the intervention and again one month and a half then proceed to complete the questionnaires.
Category
Lifestyle
2
Description
Control group: samples of the control group not received intervention and after the intervention, as well as examples of intervention group samples have attempted to complete the questionnaire.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Sima Zahri Anboohi, Ph.D of Nursing
Street address
Taleghani hospital, Arabi Ave, Yaman Ave, CHamran Highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Rezghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Yaman Ave, CHamran Highway, Tehran
City
Tehran
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 of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sima Zahri Anboohi, Ph.D of Nursing
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Yaman Ave, CHamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 9648
Fax
Email
simazohari@gmail.com; simazohari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sima Zahri Anboohi, Ph.D of Nursing
Position
Ph.D of Nursing
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Yaman Ave, CHamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 9648
Fax
Email
simazohari@gmail.com; simazohari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sima Zahri Anboohi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Yaman Ave, CHamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 9648
Fax
Email
simazohari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)