Protocol summary

Summary
From clients with heart failure who refers to Shahid Madani' s heart center 44 patients will be chosen with inclusion criteria by consecutive sampling and conveniently will divided in two intervention and control groups(n=22). The Quality of life and body activity and interpersonal support in two groups will be measured by three tools: Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List, at first and 3 months after intervention. During 3 months the control group will receive the usual care and education, and will not be limited from the routine care, but the intervention group besides the usual care and education, in first two visits will be assessed based on Roy's Assessment form, and their maladaptive behaviors will be determined, then they will receive a teaching booklet based on Roy' s adaptation model and American heart failure association Modules (included: information about their disease, diet, activity, medications, interpersonal relationship) and they will receive discussion and consult with emphasize on their adaptive behaviors. They will receive phone calls about the program objectivities and content of education every week, and every 3 week we will visit them and consult about their problems with emphasize on Roy adaptation model and about how much they follow the booklet guidelines. After 3 months the Quality of life and body activity and interpersonal support in two groups will be measured by the same tools and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101225665N1
Registration date: 2011-06-06, 1390/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-06, 1390/03/16
Registrant information
Name
Sima Lakdizaji
Name of organization / entity
Tabriz University of Medical Sciences, Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
laks@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz medical sciense university-Tabriz nursing and midwifery faculty- research deputy
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-12-06, 1390/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of teaching program based on Roy' s adaptation model on quality of life of clients with heart failure
Public title
Effect of teaching program on quality of life in heart failure clients
Purpose
Prevention
Inclusion/Exclusion criteria
1- clients with heart failure who admitted to special heart clinic 2- clients who recognised foe at least one month 3- clients with heart failure in class II or III 4- clients above 18 and below 75 years old. 5- consiuse and could communicate 6- could walking exclution criteria: 1- if clients do not have willing for participation 2- have any other medical problems 3- psychological problems or addiction
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
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
Tabriz Medical Science University- Research Deputy-Etics commitee
Street address
Research Deputy- Amoozesh bulding- Tabriz Medical Sciense University- Daneshgah Ave.- Tabriz
City
Tabriz
Postal code
East Azerbaijan
Approval date
2011-02-19, 1389/11/30
Ethics committee reference number
9562/4/5

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
quality of life
Timepoint
3 months
Method of measurement
Minosuta living With Heart Failure Questioneir

Secondary outcomes

1

Description
inter personal support
Timepoint
3 months
Method of measurement
interpersonal support list

2

Description
body activities
Timepoint
3 months
Method of measurement
6 minute walking test

Intervention groups

1

Description
At first in two groups , the Quality of life and body activity level and interpersonal support will be measured by three tools: Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List, at first and 3 months after intervention. The control group During 3 months will receive the usual care and education which is common , and they will not be limited from the routine care. /The intervention group besides the usual care and education, at first two visits will be assessed based on Roy's Assessment form, and their maladaptive behaviors will be determined, then they will receive a teaching booklet based on Roy' s adaptation model and American heart failure association Modules (includes: information about their disease, diet, activity, medications, interpersonal relationship) and they will receive discussion and consult with emphasize on their maladaptive behaviors. They will receive phone calls about the program objectivities and content of study every week, and every 3 week we will visit them and consult about their problems with emphasize on Roy adaptation model and about how much they follow the booklet guidelines. After 3 months the Quality of life and body activity and interpersonal support in two groups will be measured by the same tools (Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List) and at last two groups will compare.
Category
Lifestyle

2

Description
In Control group the Quality of life and Body activity and Inter personal support in will be measured by Minosuta Quality of life and 6 minute walking Test and Interpersonal Support List at first and 3 months after intervention. During 3 months the control group will receive the usual care and teaching and will not limited the routine care. After 3 months the Quality of life and Body activity and Interpersonal support will be measured and then will compare with intervention group .
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Educational and medical heart center
Full name of responsible person
Sima Lakdizaji
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz Medical Sciense University - Tabriz Nursing and Midwifery Faculty-Reaserch Deputy
Full name of responsible person
Soheila Bani
Street address
5138947-977, Nursing and Midwifery Faculty, Shriati Jnoobi Ave.Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical Sciense University - Tabriz Nursing and Midwifery Faculty-Reaserch Deputy
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
Tabriz Medical Science University- Research Deputy
Full name of responsible person
Mohammad Khajegodari
Position
Lecturer
Other areas of specialty/work
Street address
5137947977-Nursing and Midwifery Faculty-Tabriz Sharati Jnoobi Ave.
City
Tabriz
Postal code
5137947977
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
laks@tbzmed.ac.irlak1369@yahoo.com
Web page address
www.tbzwed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz Medical Science University- Research Deputy
Full name of responsible person
Sima Lakdizaji
Position
Lecturer- Master Sciense(MS in Nursing)
Other areas of specialty/work
Street address
5137947977- Nursing and Midwifery Faculty- Sharati Jnoobi Ave.- Tabriz
City
Tabriz
Postal code
5137947977
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
laks@tbzmed.ac.irlak1369@yahoo.com
Web page address
www.tbzwed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Medical Science University- Research Deputy
Full name of responsible person
sima lakdizaji
Position
Lecturer
Other areas of specialty/work
Street address
5137947977- Nursing and Midwifery Faculty- Sharati Jnoobi Ave.- Tabrz
City
Tabriz
Postal code
5137947977
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
laks@tbzmed.ac.irlak1369@yahoo.com
Web page address
www.tbzwed.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
Loading...