Protocol summary

Summary
Objectives: To determine the effects of hospital-based training program on self-care behaviors based on health belief model in patients with heart failure and to offer quality improvement programs for self-care to patients. Design: At first, a 70-subject sample size was determined for the study. However, considering a 20% loss rate, the sample size was increased to 84 subjects (42 in each group). Setting and conduct: In order to prevent information exchange between the patients during the intervention, randomization was done based on hospitals rather than individuals (The hospitals were selected using sealed envelopes). The patients were assessed regarding the inclusion and exclusion criteria and were entered into the study after signing written informed consents. Inclusion criteria: suffering from heart failure, being literate, and being able to communicate. Exclusion criteria: having underlying diseases such as chronic kidney disease and diabetes, being educated in medical sciences, withdrawal from the study due to personal reasons, and failure to participate in training sessions (over 2 sessions) or exams. Intervention: The patients participated in four 15-30-minute training sessions. In the first two sessions, the concept, importance, and method of self-care behaviors were taught. The patients were also provided with leaflets and videos. The subsequent sessions were held in form of question and answer. The study questionnaire was completed in three steps (before the intervention and 2 weeks and 2 months after discharge). Main outcome measures: To compare the mean scores of the health belief model structures (knowledge, perceived susceptibility, perceived severity, perceived barriers, perceived benefits, cues to action, self-efficacy, and behavior) between the two groups before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506136261N11
Registration date: 2015-11-04, 1394/08/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Trial of effect of hospital-based training program to improve self-care behaviors in heart failure patients using the Health Belief Model
Public title
The impact of hospital-based training to improve the treatment of patients with heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with heart failure who are literate and able to communicate. Exclusion criteria: underlying disease includes chronic kidney disease or diabetes, a degree in medical science, Exclusion of study due to personal reasons or failure to participate in training sessions (over 2 sessions) or exams.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 94
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Research Ethics Committee of the Department of Shiraz University of Medical Sciences, 7 floor, Shiraz University of Medical Sciences, Karim Khan Zand Blvd, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.SUMS.REC.1394.17

Health conditions studied

1

Description of health condition studied
heart failure
ICD-10 code
150
ICD-10 code description
Excl.:complicating:•abortion or ectopic or molar pregnancy (O00-O07, O08.8)

2

Description of health condition studied
conjestive heart failure
ICD-10 code
150.0
ICD-10 code description
Congestive heart failure;Congestive heart disease;Right ventricular failure (secondary to left heart failure)

3

Description of health condition studied
Left ventricular failure
ICD-10 code
150.1
ICD-10 code description
Cardiac asthma;Left heart failure;Oedema of lung;Pulmonary oedema(with mention of heart disease NOS or heart failure)

4

Description of health condition studied
Heart failure, unspecified
ICD-10 code
150.9
ICD-10 code description
Cardiac, heart or myocardial failure NOS

Primary outcomes

1

Description
Knowledge
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

2

Description
Perceived susceptibility
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

3

Description
Perceived barriers
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

4

Description
Perceived benefits
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

5

Description
Perceived severity
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

6

Description
Efficacy
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

7

Description
cues to action
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

8

Description
behavior
Timepoint
Before the intervention, two weeks and two months after the first intervention
Method of measurement
European Heart Failure Self-care Behaviour questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Due to ethical considerations regarding the control group to obtain his address, educational booklets and CD with phone and e-mail address to respond to their questions, they will be available after completion of the study.
Category
N/A

2

Description
Educational interventions with scientific content approved by professors are conducted in four sessions. The first session held on admission includes providing the patients with a brief introduction about the study objectives and their conditions, collecting information about their training needs, providing educational pamphlets, and face-to-face training for 10 minutes. The second session held during discharge includes their familiarization with self-care behaviors through face-to-face training for 20 minutes and presentation of educational clips in form of CD. The third session held two weeks after discharge includes questions about performance of the intended behaviors at home, responding to the patients’ questions by meeting them in the clinic (considering the physicians’ visit), and collecting information. Finally, the last training session held at the end of the fifth and sixth weeks after discharge (considering the physicians’ next visit) includes review of the previously learnt issues, question and answer, and problem solving. The patients will be reminded to attend the meeting through making phone calls and sending SMS. This session will be held for groups of 7 to 10 subjects for one hour. The third stage of data collection will be carried out within the ninth and tenth weeks after discharge (considering the physicians’ next visit in the clinic).
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Martyr Doctor Faghihi
Full name of responsible person
Zakieh Khoramaki
Street address
Hospital Martyr Doctor Faghihi, Zand Blvd, Shiraz, Iran
City
Shiraz

2

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Zakieh Khoramaki
Street address
Hospital Namazi,Zand Blvd, Shiraz, Iran.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Shiraz University of Medical Sciences
Street address
Vice Chancellor for research of Shiraz University of Medical Sciences, 7 Floor, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz 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
School of Public Health
Full name of responsible person
Dr mohammad Hosein Kaveh
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health- Fatholmobyn alley- Zahra alley- Shiraz- Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3725 1001
Fax
Email
kaveh@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Dr mohammad Hosein Kaveh
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health- Fatholmobyn alley- Zahra alley- Shiraz- Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3725 1001
Fax
Email
kaveh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Dr mohammad Hosein Kaveh
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health- Fatholmobyn alley- Zahra alley- Shiraz- Iran
City
shiraz
Postal code
14336 - 71348
Phone
+98 71 3725 1001
Fax
+98 37251007
Email
kaveh@sums.ac.ir
Web page address
http://schealth.sums.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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