Objectives: this study has been performed with the aim of investigating the effect of telenursing in caregivers of heart failure patients on patient’s self-care behaviors and clinical parameters.
Design: this not blinded randomized clinical trial was performed among 66 heart failure patients that referred to clinic of Abadan Taleghani hospital.
Sitting and conduct: Heart failure patients with inclusion criteria that referred to clinic were randomly assigned to control, intervention- group 1 and intervention- group 2 by table of random numbers.
Participants: class II and III of heart failure patients with 40 years old or greater
Interventions: caregivers did not receive any intervention in control group, caregivers were received verbal education in intervention- group 1, and continuum phone follow-up plus verbal education in intervention- group 2.
Main outcomes: self-care behavior, fatigue severity, exercise tolerance and dyspnea severity of patients were assessed by self-care behavior questionnaire, fatigue severe scale, six minutes walking test and dyspnea Borg scale at baseline and end of 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080829184N2
Registration date:2016-08-27, 1395/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-27, 1395/06/06
Registrant information
Name
Maryam Heidari
Name of organization / entity
Abadan School of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613335672
Email address
heidari-ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Abadan School of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-15, 1395/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of telenursing and not follow-up in caregiver of heart failure patients on self-care behaviors and clinical status of patients
Public title
comparison the effect of telenursing and not follow-up on clinical status of heart failure patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: class II and class III of heart failure that confirmed by physician based on New York Heart Association criteria; age 40 years or greater; absence of major psychiatric disorder; absence of series diseases such as musculoskeletal disorders, cancer, unstable angina, heart attack in last month; be available the caregiver in home; caregiver be able to speak and read Persian; caregiver be available for calling.
Exclusion criteria: caregiver not be available for calling in determination times.
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
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 Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences, near of Abadan airport, Abadan, Iran
City
Abadan
Postal code
6153365494
Approval date
2015-01-14, 1393/10/24
Ethics committee reference number
IR.ABADANUMS.REC.1394.7
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
150.9
ICD-10 code description
Cardiac, heart or myocardial failure NOS
Primary outcomes
1
Description
Self-care behaviore
Timepoint
Before intervention- 3 months after intervention
Method of measurement
Self-care behavior in heart failure questionnaire
Secondary outcomes
1
Description
Exercise tolerance
Timepoint
Before intervention-3 months after intervention
Method of measurement
Six minutes walking test
2
Description
Dyspnea
Timepoint
Before intervention-3 months after intervention
Method of measurement
Dyspnea Borg scale
3
Description
Fatigue
Timepoint
Before intervention-3 months after intervention
Method of measurement
Fatigue severe scale
Intervention groups
1
Description
Intervention- group 2: Receive educational plan and continuum phone follow-up
Category
Rehabilitation
2
Description
Intervention- group 1: Receive educational plan
Category
Rehabilitation
3
Description
Control group: Do not receive intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadan Ayatolah-Taleghani hospital
Full name of responsible person
Maryam Heidari
Street address
Abadan School of Medical Sciences, near of Abadan airport, Abadan, Iran
City
Abadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Abadan School of Medical Sciences
Full name of responsible person
Mohammad Mahboubi
Street address
Abadan School of Medical Sciences, near of Abadan airport, Abadan, Iran
City
Abadan
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 Abadan School 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
Abadan School of Medical Sciences
Full name of responsible person
Meryam Heidari
Position
Master of Sciences
Other areas of specialty/work
Street address
Abadan School of Medical Sciences, near of Abadan airport, Abadan, Iran