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The Effect of Roy’s Adaptation Model-Based Patient Education on The Quality of Life of Patients with Heart Failure

Protocol summary

Summary
This single-blind clinical study aims to determine the effect of adaptation-based educational program on heart failure patients' quality of life. Research subjects will be selected using purposive sampling technique based on inclusion criteria. They will be divided blocked randomly into two groups. Inclusion criteria include: diagnosis of class I, II, III heart failure by a physician, according to the American Heart Association and clinical and laboratory evidence, at least 6 months before the study; ejection fraction of 40% or below; no mental disorder; normal hearing, vision and mental capabilities that allow making communication; age range from 18 to 65 years; no contraction of other chronic diseases such as kidney or liver failure, chronic pulmonary obstructive diseases, neural and motor disorders, except diabetes; having access to patients for follow-up controls; walking capability; and not receiving the same training in other centers. Exclusion criteria include: unwillingness to participate for any reason; moving from the research region during the study; and more than two times absence from training sessions. In this study, 38 cardiac patients will receive group training intervention based on the Roy's Adaptation Model for one month And since the beginning of the intervention period up to one month after a group training, individual training on the telephone and physically will receive based maladaptive behaviors; in addition, another 38 patients will receive routine training. One month after the intervention, the quality of life of both groups will be measured based on the Roy's inventory and Minnesota's questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010625880N1
Registration date: 2016-05-12, 1395/02/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Akram Mansouri
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8621
Email address
mansouri.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaze University of Medical Sciences
Expected recruitment start date
2015-12-19, 1394/09/28
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Roy’s Adaptation Model-Based Patient Education on The Quality of Life of Patients with Heart Failure
Public title
The Effect of Education on Quality of Life in Patients With Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria are: diagnosis of class I, II, III heart failure by a physician, according to the American Heart Association and clinical and laboratory evidence, at least 6 months before the study; ejection fraction of 40% or below; no mental disorder; normal hearing, vision and mental capabilities that allow making communication; age range from 18 to 65 years; no contraction of other chronic diseases such as kidney or liver failure, chronic pulmonary obstructive diseases, and neural and motor disorders, except diabetes; having access to patients for follow-up controls; walking capability; and not receiving the same training in other centers. Exclusion criteria include: unwillingness to participate for any reason; moving from the research region during the study; and more than two times absence from training sessions.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
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
Ahvaze University of Medical Sciences
Street address
Ahvaze University of Medical Sciences, Gholestan Square, Ahvaze, Khuzestan, Iran
City
Ahvaze
Postal code
00986133361983
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.AJUMS.REC.1394.504

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
150.20و150
ICD-10 code description
Chronic Systolic (Congestive) Heart Failure

Primary outcomes

1

Description
Quality of Life
Timepoint
Before Intervention and one Month After Intervention
Method of measurement
Minnesota Questionnaire, Roy Questionnaire

Secondary outcomes

1

Description
Adaptation
Timepoint
before itervention and one month after intervention
Method of measurement
Roy Questionnaire

Intervention groups

1

Description
Control Group Did not Receive Behavioral Intervention and Receive only Treatment Routine Care.
Category
Behavior

2

Description
Type of Intervention Is Behavioral, In addition to routine medical cares, the intervention group will receive weekly 45-minute sessions of Roy's Adaptation Model-based training for one month. This group will also receive a follow-up procedure through phone contact, during which the positive behaviors of the patients will be encouraged and strengthened by stating the advantages of such behaviors; whereas, their negative behaviors will be undermined by mentioning their complications and disadvantages. The intervention group will also receive telephone and physically individual consultation. The educational content will be gathered and developed based on nursing and medical literature review. Presentation of educational content during the 4 sessions will be as follows: • The first session: definition of heart failure, signs and symptoms of the disease, how to perform exercise and physical activities.• The second session: diet and fluid intake, tobacco use, alcohol consumption, daily weighing and its interpretation.• The third session: training in medications, their complications, and how to adjust drug dosing.• The fourth session: Management of and adaptation to symptoms, sexual problems, and stresses. If patients need more help to shape adaptation behaviors, they will be referred to other treatment team members based on the type of behavior and its stimulator (e.g. referral to a specialized physician for drug dosing adjustment). The researcher will provide patients with continuous follow-ups from the beginning of the intervention onward. In fact, these telephone follow-ups and the time spent on visiting patients physically and individually, will create a sense of support in them, which is associated with psychologically positive effect. During the whole program, patients will be encouraged to have one companion in training sessions. A handout, entitled
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Therapy Clinics of Shushtar
Full name of responsible person
Mohsen Jmali
Street address
Khatamolanbia Haspital, Farhangh High way, Shoushtar, Khuzestan, Iran
City
Shoushtar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaze University of Medical Sciences
Full name of responsible person
Mr Shahram Baraz
Street address
Ahvaze University of Medical Sciences, Gholstan Highway, Ahvaze, Khuzestan, Iran
City
Ahvaze
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaze University 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
Ahvaz University of Medical Sciences
Full name of responsible person
Doctor Shahram Baraz
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing, Ahvaze University of Medical Sciences, Gholstan Highway, Ahvaze, Khuzestan
City
Ahvaz-
Postal code
00986133738333
Phone
00
Fax
Email
shahrambaraz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Mansouri
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing, Ahvaze University of Medical Sciences, Gholstan Highway, Ahvaze, Khuzestan
City
Ahvaze
Postal code
00989353772927
Phone
00
Fax
Email
Mansouri.A@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Mansouri
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing, Ahvaze University of Medical Sciences, Gholstan Highway, Ahvaze, Khuzestan
City
Ahvaze
Postal code
00989353772927
Phone
00
Fax
Email
Akram.Mansouri2@gmail.com
Web page address

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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