1. Home
  2. Approved trials
  3. » فارسی

The effect of family-centered empowerment model and usual care on hope and quality of life for patients with failure

Protocol summary

Summary
The objective of this study is to investigate the effect of family-centered empowerment model on hope and quality of life of patients with heart failure.In this clinical trial after obtaining permission from the authorities, hospitals and code of ethics and informed consent of the person subject to inclusion criteria, Of heart failure patients admitted to the CCU government hospitals in Ahvaz, the purposive sampling method randomly selected samples of family-centered empowerment model runs. Samples randomly are divided into two groups and training required will be implemented in accordance with the four-step model of family-centered empowerment. Inclusion criteria are patients' age above 40 years, at least 6 months after heart failure improvement, without history of mental illnesses such as schizophrenia, having full knowledge and access to the telephone tool, Ability to communicate and answer questions, ejection fraction between 20%-40%. Exclusion criteria are an unwillingness to cooperate, readmission, mortality.The intervention group contains 4 to 10 subjects groups during 4 weekly sessions will be presented within a month, also for 4 weeks, we have to follow up weekly phone calls. Two questionnaires including inventory Minnesota for quality of life and Schneider life expectancy measurement are used in 4 time points including before the intervention, the end of the second session, four and three months after intervention. The control group will complete two questionnaire in two time points. No training program will hold for control group, they only receive routine treatment. The primary outcome variable include quality and life expectancy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071028862N1
Registration date: 2017-04-29, 1396/02/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-29, 1396/02/09
Registrant information
Name
Zahra Ahmadi Batvand
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3229 1284
Email address
ahmadi.za@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model and usual care on hope and quality of life for patients with failure
Public title
Assesment of the effect family-centered Empowerment model on hope and quality of life in patient with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 40 years; at least 6 months after the last in the family is sick heart failure patients; history of mental illnesses such as schizophrenia do not have, having full knowledge and access to the telephone instrument; Ability to communicate and answer questions; ejection fraction less than or equal to 40% of heart patients is not the disease is debilitating complications such as heart ejection fraction of 20% or less. Exclusion criteria: an unwillingness to cooperate; readmission; mortality.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
none

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Boulevared, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.AJUMS.REC. 1395. 158

Health conditions studied

1

Description of health condition studied
Hope and quality of life in patient with heart failure
ICD-10 code
none
ICD-10 code description
none

Primary outcomes

1

Description
Hope of life
Timepoint
Before, the second session, the fourth session and 3 months after intervention
Method of measurement
Questionnaire and respond to questions, and reduced hospitalizations by 70% within a month

2

Description
Quality of life
Timepoint
Before, the second session, the fourth session and 3 months after intervention
Method of measurement
Questions and answer the questionnaire 70%

Secondary outcomes

empty

Intervention groups

1

Description
Patients in the control group received usual care hospitals and related questionnaires filled out twice.
Category
N/A

2

Description
Patients in the intervention group received weekly sessions of relevant training and follow-up phone call fall.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zhaleh Mehrabzadeh
Street address
Imam Hospital, Azadegan street
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzadeh
Street address
Golestan Boulevared
City
Ahvaz
Grant name
13000000
Grant code / Reference number
none
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Batvandi
Position
Nursing expert
Other areas of specialty/work
Street address
No. 103, Street 1, Naseh Gharbi boulevard, Sad Dastgah district
City
Ahvaz
Postal code
6176965384
Phone
+98 61 3229 1012
Fax
none
Email
z4hr4.ahmadi@gmail.com
Web page address
none

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Nasrin Elahi
Position
PHD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan boulevard
City
Ahvaz
Postal code
61357-15794
Phone
+98 61333737320
Fax
none
Email
ELAHI.N@ajums.ac.ir
Web page address
none

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Rokh afroz Darush
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Golestan boulevard, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Postal code
61357-15794
Phone
+98 61333737320
Fax
none
Email
rokhafroz@ajums.ac.ir
Web page address
none

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
Loading...