Objective: Determining the effect of the self- monitoring program implementation on outcomes of patients with heart failure (2) Design: Parallel Single blind clinical Controlled trial (3) Setting and conduct: Selecting 54 patients with heart failure referring to heart failure clinic of Tehran Heart Center affiliated to Tehran university of medical sciences and assigning them to two groups of intervention and comparison by simple random allocation method. (4) Participants including major eligibility criteria: Inclusion Criteria: age older than 18 years old, diagnosis of HF, availability to telephone; ability of reading and writing in Farsi language, having a working weighing scale at home; without diagnosed defect of hearing and sight; stable hemodynamic status; not smoking and drinking alcohol and addiction to substance; living with family or caregiver. Exclusion Criteria: Diagnosis of psychiatric and cognitive conditions; unavailability of patients during call follow- up stage; Filling- in self- monitoring charts for less than 60 percent; cardiac surgery, awaiting or receiving heart transplant or left ventricular assistive device. (5) Intervention: Education on living well with heart failure based on booklet prepared by Australian Heart Foundation and using weight and shortness of breath self- monitoring charts for three months after referring during one- hour educational session by researcher nurse at heart failure clinic of Tehran Heart Center, and 5-15 minute- call-follow up during 1, 3 and 7 days after referring and every week for 3 months (6) Main outcome measures (variables): self-care, Heart Failure Knowledge, quality of life, and hospital admission before and 3 months after initiation of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021032476N1
Registration date:2017-04-07, 1396/01/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-07, 1396/01/18
Registrant information
Name
Mahin Nomali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-nomali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-06-11, 1396/03/21
Expected recruitment end date
2017-11-12, 1396/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Self- monitoring Program on Outcomes of Patients with Heart Failure
Public title
Effect of Self- monitoring Program on Outcomes of Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: age older than 18 years old, diagnosis of HF, availability to telephone; ability of reading and writing in Farsi language, having a working weighing scale at home; without diagnosed defect of hearing and sight; stable hemodynamic status; not smoking and drinking alcohol and addiction to substance; living with family or caregiver.
Exclusion Criteria: Diagnosis of psychiatric and cognitive conditions; unavailability of patients during call follow- up stage; Filling- in self- monitoring charts for less than 60 percent; cardiac surgery, awaiting or receiving heart transplant or left ventricular assistive device.
Age
From 18 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Qods street, Research deputy of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1653
Health conditions studied
1
Description of health condition studied
Heart Fialure
ICD-10 code
I50
ICD-10 code description
Heart Failure
Primary outcomes
1
Description
Self-care
Timepoint
Before begining of the study and 2 months later at the end of the study
Method of measurement
Measurement of self-care by Self-Care Heart Failure Index (SCHFI)
Secondary outcomes
1
Description
Quality of life; and hospital reamission
Timepoint
Before initiation of the study and 2 months later at the end of the study
Method of measurement
Measurement of quality of life by Minnesota Living With Heart Failure Questionnaire (MLHFQ) ; and hospital readmission by asking patients about the number, place, treatment, chief complaints and cause of admissions during call follow- up stage
Intervention groups
1
Description
Intervention group: Education on living well with heart failure based on booklet prepared by Australian Heart Foundation and using weight and shortness of breath self- monitoring charts for two months after discharge during a 120- minute educational session by researcher nurse at heart failure clinic of Tehran Heart Center, and 5-15 minute- call-follow up during 1, 3 and 7 days after discharge and every week for 2 months
Category
Behavior
2
Description
Control group: they receive no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
North Kargar Street, Tehran, Iran
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Keshavarz Blvd., Qods street, Research deputy of Tehran university of medical sciences
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahin Nomali
Position
MS.c student of Critical Care Nursing
Other areas of specialty/work
Street address
Nosrat street, Tohid square, School of Nursing and Midwifery, Tehran University of Medical Sciences,
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
mahin.nomali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maasumeh Zakeri Moghadam
Position
Ph.D of Nursing
Other areas of specialty/work
Street address
Nosrat street, Tohid square, School of Nursing and Midwifery, Tehran University of Medical Sciences,
City
Tehran
Postal code
Phone
+98 21 2286 2160
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahin Nomali
Position
MS.c student of Critical Care Nursing
Other areas of specialty/work
Street address
Nosrat street, Tohid square, School of Nursing and Midwifery, Tehran University of Medical Sciences,
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
mahin.nomali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)