Determining the effect of telephone follow-up after discharge on dignity of patients with heart failure
Design
Clinical trial with control group with parallel group and randomized design. Each group consists of 35 patients. There is no blinding in the study
Settings and conduct
After selecting patients from heart department of Imam Hossein Hospital of Shahrood, for each patient in intervention group, after discharge, once a week for one month, telephone follow up about drug use, symptoms, daily activities and the type of nutrition will take place. Before and one month after intervention, the social dignity and inherent dignity questionnaire will be completed for patients in both groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 40 years old; Patients with heart failure;
It is possible to make phone calls with patient; Ability to speak in Persian
Non inclusion criteria: Those who are health care workers
Intervention groups
Intervention group: Each patient in the intervention group will be followed up after discharge, once a week for one month, in relation to the use of medications, symptoms, daily activities and type of nutrition.
Control group: The control group will not receive intervention and will only receive routine care and care at the hospital and discharge time.
Main outcome variables
Dignity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100114003064N14
Registration date:2019-02-08, 1397/11/19
Registration timing:registered_while_recruiting
Last update:2019-02-08, 1397/11/19
Update count:0
Registration date
2019-02-08, 1397/11/19
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telephone follow-up after discharge on dignity of patients with heart failure
Public title
Telephone follow-up and dignity of patients with heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 40 years
Patients with heart failure
It is possible to make phone calls with patient
Ability to speak in Persian
Exclusion criteria:
Those who are health care workers
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected based on inclusion criteria and will be randomly assigned into two groups: A (telephone follow-up) and B (control group). As patients gradually enter the study, and also because the number of allocated patients will be equal to each group, blocks of size 4 will be used by SPSS software to create a random allocation sequence. The random allocation sequence will be concealed. In this way, there will be 70 envelopes that A and B codes will be put in them. The envelopes will be numbered. Individuals will be coded according to their entry into the study, and an envelope will be allocated for each patient.
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 Shahroud University of Medical Sciences
Street address
Hafte-Tir Sq.,
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.SHMU.REC.1397.177
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Patient Dignity
Timepoint
At the beginning of the study (before the intervention) and one month after
Method of measurement
Social Dignity Questionnaire & Inherent Dignity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After selecting patients and before patient discharge, an educational package containing information such as the date of the visit of the doctor, recommendations for medications and symptoms, daily exercise and diet, along with oral explanations, will be provided to each patient in intervention group. After discharge, once a week for one month, telephone follow up about drug use, symptoms, daily activities and the type of nutrition will take place. Before and one month after intervention, the social dignity and inherent dignity questionnaire will be completed for patients in both groups.
Category
Rehabilitation
2
Description
Control group: The control group will not receive intervention and will only receive routine care and care at the hospital and discharge time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Hossein Bagheri
Street address
28-meteri Touhidi, Imam Khomeini Street
City
Shahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3234 2000
Email
bagheri@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Assistant professort
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mr. Hossein Bagheri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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