Comparison the effects of group training with teach back method with and without telephone follow-up on quality of life and hospital readmission of patients with heart failure with heart failure
The purpose of this randomized clinical trial is to assess the effects of group training with teach back method with and without telephone follow-up on quality of life and hospital readmission of patients with heart failure. After obtaining informed consent from patients, 100 patients with heart failure will select and randomly will divide into two experimental (n=50) and control (n=50) groups, without patients awareness from group assignment. Control group will receive only routine of clinical training, but intervention group will receive education with teach back method besides routine training. After that, for assessing the effect of telephone follow-up, both the control and experimental groups will randomly divide into two subgroups: The first intervention and control groups will follow up by telephone in second and fourth week after training, but the second intervention and control groups will not follow up by telephone. Then, one month after the training, quality of life and hospital readmission will be evaluated in each 4 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091319146N1
Registration date:2014-10-11, 1393/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-11, 1393/07/19
Registrant information
Name
madineh dastoom
Name of organization / entity
oloompezeshki jondishapoor ahwaz
Country
Iran (Islamic Republic of)
Phone
+98 67 2322 4916
Email address
dastoom.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences.
Expected recruitment start date
2014-08-11, 1393/05/20
Expected recruitment end date
2014-11-11, 1393/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of group training with teach back method with and without telephone follow-up on quality of life and hospital readmission of patients with heart failure with heart failure
Public title
The effects of group training with teach back method with and without telephone follow-up on quality of life and hospital readmission of patients with heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: being older than 40 years old; diagnosis of heart failure by the attending physician; presence of heart failure at least 6 months from diagnosis; having fully consciousness and being familiar with Persian language, lack of any psychiatric diseases such as schizophrenia; lack of drug addiction; lack of acute physical illness such as dialysis or any other diseases that prevent the learning process.
Exclusion criteria: patient refusal to continue follow-up; any physical problems other than those related to heart failure or mental problems that occur during intervention and prevent training process; being absence in two training sessions continually.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapor University of Medical Sciences Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khozestan.
City
Ahvaz
Postal code
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
ajums.REC.1393.165
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
Readmission rate
Timepoint
Baseline and one month after the intervention
Method of measurement
Ask the patient, their family and reading medical records
2
Description
Quality of Life
Timepoint
Baseline and one month after the intervention
Method of measurement
Minnesota Heart Failure Quality of Life Questionnaire
Secondary outcomes
1
Description
Physical dimensionl of quality of life
Timepoint
Before and one month after intervention
Method of measurement
Quality of life questionnaire
2
Description
Spiritual dimension of quality of life
Timepoint
Before and one month after intervention
Method of measurement
Quality of life questionnaire
3
Description
Socio-economic dimension of quality of life
Timepoint
Before and one month after intervention
Method of measurement
Quality of life questionnaire
Intervention groups
1
Description
In intervention group, patients will train with group teach back method. At first, details will describe with simple language for patients; then patients will ask to recount the educational training with their own language until access to patients’ comprehension thoroughly. To investigate the effect of telephone follow-up, patients will divide into two groups. The first intervention group will follow up by telephone in second and fourth week after training, but the second intervention group will not follow up by telephone. Then, one month after the training, quality of life and hospital readmission will be evaluated in both groups.
Category
Prevention
2
Description
In control group, routine hospital training will present and for assessing the effectiveness of telephone follow-up, patients will divide into two groups. The first control group will follow up by telephone in second and fourth week after training, but the second control group will not follow up by telephone. Then, one month after the training, quality of life and hospital readmission will be evaluated in both groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini hospital
Full name of responsible person
Madineh Dastoom
Street address
Imam Khomeini hospital, end of 24 meters, Ahvaz, Khozestan