Protocol summary

Summary
Objective: To determine the effect of tele nursing on self-care for heart failure patients Study design: a single-blind randomized clinical trial in purpose-based access Study population: patients with heart failure who were referred to health care centers Kohgiluyeh and Boyer-Ahmad Inclusion criteria : Literacy; Access to telephone at home; lack of problems related to speech and hearing؛ younger than 85 years; Lack of advanced form of the disease known vital organs and mental disorders. Exclusion criteria : hospitalization during the study period; The patient's unwillingness to continue to cooperate. Intervention: 1. Registration of eligible volunteers, explaining the method, take the consent 2- Self-care and demographic questionnaire completed and randomly divided into two groups and control experience.3. Self-care training in heart failure (face-to-face training methods and using the booklet), individual counseling, self-care recommendations in writing to two groups4.Contact telephone intervention group experienced 12-week follow-adherence to self-care recommendations in the first month three times a week and twice a week during the second month and contents of conversations is (duration of the call 10 minutes and make calls 8 am to 8 pm)include an assessment of the adherence to self-care program and Analysis of the situation by one to find trouble and provide solutions proposed and answers to questions and advice to patients. Study outcome: improved self-care.

General information

Acronym
Self-care for heart failure patients
IRCT registration information
IRCT registration number: IRCT2015081823669N1
Registration date: 2016-09-25, 1395/07/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-25, 1395/07/04
Registrant information
Name
Leila Sadat Nematollahi
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 5611
Email address
noorian.khairollah@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2014-06-20, 1393/03/30
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Telenursing impact on self-care for heart failure patients.
Public title
Telephone follow up by nurse their impact on improving care for patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Literacy; Access to telephone at home; lack of problems related to speech and hearing؛ younger than 85 years; Lack of advanced form of the disease known vital organs and mental disorders. Exclusion criteria : hospitalization during the study period; The patient's unwillingness to continue to cooperate.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
These factors include issues such as approval by a cardiologist and vascular disease, drug therapy being, has Svadkhvandn and write access to the phone at home, hearing loss and speech problems, age less than 85 years, lack of advanced disease of vital organs known and mental disorders as well as during the study were not admitted into the informed consent form were completed.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, SHahid Motahhari Blvd, Yasuj
City
Yasuj
Postal code
75919-94799
Approval date
2015-02-22, 1393/12/03
Ethics committee reference number
93.12.03.10

Health conditions studied

1

Description of health condition studied
heart failure
ICD-10 code
I30-I52
ICD-10 code description
Heart failure, unspecified

Primary outcomes

1

Description
Self care
Timepoint
Before and 2 months after intervention
Method of measurement
European questionnaires self-care behaviors in patients with heart failure (item 12)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Registration of eligible volunteers, explaining the method, take the consent 2- Self-care and demographic questionnaire completed 3. Self-care training in heart failure (face-to-face training methods and using the booklet), individual counseling, self-care recommendations in writing to two groups4.Contact telephone intervention group experienced 12-week follow-adherence to self-care recommendations in the first month three times a week and twice a week during the second month and contents of conversations is (duration of the call 10 minutes and make calls 8 am to 8 pm)include an assessment of the adherence to self-care program and Analysis of the situation by one to find trouble and provide solutions proposed and answers to questions and advice to patients.
Category
Behavior

2

Description
control group: Registration of eligible volunteers, explaining the method, take the consent 2- Self-care and demographic questionnaire completed 3. Self-care training in heart failure (face-to-face training methods and using the booklet), individual counseling, self-care recommendations in writing.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
SHahid Mofateh Clinic
Full name of responsible person
Ali Emami
Street address
SHahid Mofateh Clinic, SHahid Montazeri Street ,Yasuj
City
Yasuj

2

Recruitment center
Name of recruitment center
Emam Sajad hospital
Full name of responsible person
Maasume Davoodi
Street address
Near the campus of Medical Sciences, Doctor Galil street, Yasuj.
City
Yasuj

3

Recruitment center
Name of recruitment center
Ehsan Abedi doctor's office
Full name of responsible person
Mahbube Nejati
Street address
Ehsan Abedi doctor's office, Bladyan Street , Gachsaran
City
Gachsaran

4

Recruitment center
Name of recruitment center
SHahid Beheshty Hospital
Full name of responsible person
Ali Emami
Street address
SHahid Beheshty Hospital, SHahid Montazeri Street, Yasuj
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj Univercity Medical Science
Full name of responsible person
Mohammad Naraki
Street address
Yasuj University of Medical Sciences, SHahid Motahhari Blvd, Yasuj
City
Yasuj
Grant name
3
Grant code / Reference number
74
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj Univercity Medical Science
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
Yasuj Univercity Medical Science
Full name of responsible person
Shahla Najafy
Position
Deputy of nursing school
Other areas of specialty/work
Street address
Yasuj Univercity Medical Science, SHahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3323 4115
Email
shhlaaiss@yahoo.com
Web page address
www.yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj Univercity of Medical Science
Full name of responsible person
khairollah Noorian
Position
PhD of nursing
Other areas of specialty/work
Street address
Yasuj Univercity of Medical Science, SHahid motahari Blvd, Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 3334 6077
Fax
+98 74 3334 6078
Email
noorian20@yahoo.com
Web page address
www.yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasuj Univercity of Medical Science
Full name of responsible person
leila sadat Nematollahi
Position
Nursing student
Other areas of specialty/work
Street address
Yasuj Univercity of Medical Science , SHahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 3334 6077
Fax
+98 74 3334 6078
Email
Nematollahi76@yahoo.com
Web page address
www.yums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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