Clinical trial of the comparison of the effect of clinical follow up and routine discharge plan on quality of life and hospitalization of patients with heart failure
The aim of this study was to determine the effect of clinical follow-up on quality of life and re-admission of patients with heart failure.
Design
It is a clinical randomized controlled trial study. 130 patients with heart failure who are referred to hospitals of Kerman University of Medical Sciences will be selected and randomly assigned to intervention or control groups. Randomization will be done through blocking method.
Settings and conduct
Sampling will be done at the Shafa Hospital of Kerman University of Medical Sciences. Randomization will be done using a randomized block design, the subjects are assessed and assigned through blocks of four (two in intervention and two in control group). Block randomization and statistical analysis are performed by a statistician who does not have information about patient randomization process.
Participants/Inclusion and exclusion criteria
Having heart failure and having no mental illnesses
Intervention groups
In the intervention group, the nurse will educate patient the post-discharge information. In the course of the clinical follow up the nurse will follow patients by telephone and refer them to the hospital in case of emergencies. The follow ups include medication control, regular exercise, and symptom relief. The control group will receive regular training during discharge.
Main outcome variables
The data will be collected using the quality of life questionnaire for patients with heart failure and hospitalization information. The quality of life questionnaire will be completed before the intervention and 3 months after the discharge. Re-admission and quality of life are two main outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100911004728N3
Registration date:2018-01-20, 1396/10/30
Registration timing:registered_while_recruiting
Last update:2018-01-20, 1396/10/30
Update count:0
Registration date
2018-01-20, 1396/10/30
Registrant information
Name
Hadi Ranjbar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6862
Email address
ranjbar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the comparison of the effect of clinical follow up and routine discharge plan on quality of life and hospitalization of patients with heart failure
Public title
The effect of clinical follow-up on quality of life and re-admission of patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with heart failure
Who have tendency to participate in research
ejection Fraction =< 40 %
Pass at least one year from diagnosis
New York Heart Association class III/IV heart failure
Access to Follow-up for at least 3 month
Exclusion criteria:
Previous history of dementia or other diseases based on medical records
Valvular disease requiring surgery
Other diseases that require readmission
Work in health related professions such as medicine
Heart transplantation has been done on him/her (Heart transplantation history )
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be performed using blocking. So that in each block two of the intervention group and two of the control group will enter.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person responsible for data gathering and Statisticianwill not have access to patients randomization data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Deputy of research, Kerman University of Medical Sciences, Jahad street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2017-07-04, 1396/04/13
Ethics committee reference number
IR.KMU.REC.1395.196
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Quality of Life
Timepoint
Before intervention, one, two and three months after discharge
Method of measurement
Heart failure Quality of life Questionnaire
2
Description
Readmission
Timepoint
Three months after Discharge
Method of measurement
Follow up
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Routine education and follow ups including Education about drugs, Diet, follow up visits and routine follow up plan of hospital
Category
Other
2
Description
Intervention group: Clinical follow up through telephone, visiting patients' home or invite them to visit the health facility
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mansour Arab
Street address
Kosar Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
marab112004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Research and technology Deputy, Ebne Sina St., Tahmasb Abbad Crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
marab112004@yahoo.com
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 Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Medical University Campus, Kerman University of Medical Sciences, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 343205179
Fax
Email
marab@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Medical University Campus, Kerman University of Medical Sciences, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 343205179
Fax
Email
marab@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Medical University Campus, Kerman University of Medical Sciences, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 343205179
Fax
Email
marab112004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the individual participant data collected during the trial, after deidentification
When the data will become available and for how long
Immediately following publication. No end date.
To whom data/document is available
Anyone who wishes to access the data.
Under which criteria data/document could be used
To gain access, data requestors will need to sign a data access agreement. The data is available for any purpose.
From where data/document is obtainable
All applications should be sent to marab112004@yahoo.com
What processes are involved for a request to access data/document
All requests will be answered within a maximum of one month by email.