Determining the effect of palliative care education on self-efficacy of elderly patients with chronic heart failure
Design
This study is a randomized clinical trial with control group. First, 48 qualified patients will be selected using convenience sampling. Then Participants based on the self-efficacy scores will be classified into two intervention and control groups (24 patients in each group) by" Stratified Randomization" method. In this study, the phase of clinical trials is not applicable.
Settings and conduct
This randomized control trial study will be done in 5th Azar Medical and Educational Center. Because of the nature of interventions which is obvious for patient, the blindness is not possible
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 60 and 80 years old; the willingness to participate in the study; known case of grade 3 heart failure; not attending in education course with similar topics at the same time; lack of psychiatric disorder; lack of musculoskeletal diseases; lack of hearing impairment and lack of visual impairment.
Exclusion criteria: cancel participating in the study; traveling or change the living place.
Intervention groups
For the intervention group, in addition to the usual care, the educational palliative care package, for 6 weeks, in groups of 6 to 8 people, once a week, one-hour training classes, will be implemented.
Main outcome variables
Self-efficacy
General information
Reason for update
Acronym
CHF: Chronic Heart Failure
IRCT registration information
IRCT registration number:IRCT20160521027993N1
Registration date:2018-06-28, 1397/04/07
Registration timing:registered_while_recruiting
Last update:2018-06-28, 1397/04/07
Update count:0
Registration date
2018-06-28, 1397/04/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17134421660
Email address
tazikeh@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of palliative care education on self efficacy of elderly with Chronic Heart Failure
Public title
Palliative care and self efficacy in elderly with CHF
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 60 and 80 years old
The willingness to participate in the study
Known case of grade 3 heart failure according to medical records which approve by the cardiologist
Not attending in education course with similar topics at the same time
Lack of psychiatric disorder
Lack of musculoskeletal diseases
Lack of hearing impairment
Lack of visual impairment
Exclusion criteria:
Cancel participating in the study
Traveling or change the living place
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be carried out in an accessible manner to 48 people. And the scores obtained from the questionnaire will be arranged from small to large, respectively. Then, according to the scores obtained, the classes of two or four
or more with a pair number will be formed. Grades that are not included the paired groups, will be eliminated. Then a series to either ABABAB or BABABA, was meaked and select one of these series randomly and each person will be in the target group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The Blinding will be done by a single blind and will be performed before the determination of the intervention group and the control group. At first, participants (48) people fill in demographic information, clinical information, and Sullivan cardiac self-efficacy questionnaire and to fill up, in the next turn of the same questionnaire, they will be notified by telephone. After determining the intervention and control groups (patients (24) in each group), for palliative care educational classes, only will be notified into the intervention group and training classes without the knowledge of the control group, in an appropriate place at the clinic will run. After finish the training classes, immediately and one month after the follow up, the questionnaires will again be filled in for both groups (intervention and control), so that the intervention and control group does not have any meeting.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.GOUMS.REC.1397.002
Health conditions studied
1
Description of health condition studied
Chronic Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Self efficacy
Timepoint
Before intervention (pre-test) and immediate and one month after intervention (post test)
Method of measurement
Sullivan's cardiac self efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for participants in the intervention group the palliative care package, according to the WHO protocol, will be trained for 6 weeks, in groups of 6 to 8 people, once a week. The educational content included physical problems management and strategies for promoting physical activity, self-care (Diet, sleep pattern, proper use of drugs and no smoking) and psychological and spiritual care and social communication.
Category
Lifestyle
2
Description
Control group: routine care without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
5th Azar Medical and Educational Center
Full name of responsible person
Nasser Saffar
Street address
6th Azar, 5Azar Street, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Fax
+98 17 3222 8363
Email
modir-5azar@goums.ac.ir
Web page address
http://goums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir/
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Ameneh Tazikeh Lemeski
Position
Ms Student of Nursing Geriatric
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
tazikeh.a94@gmail.com
Web page address
http://goums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahnaz Modanloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
modanloo.mahnaz@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ameneh Tazikeh Lemeski
Position
Master Student Of Nursing Geriatric
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
tazikeh.a94@gmail.com
Web page address
http://goums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD will be shared.
When the data will become available and for how long
6 months after publication the data files will be available.
To whom data/document is available
The data will be shared for people working in academic institutions.
Under which criteria data/document could be used
Meta analyses on data is permitted.
From where data/document is obtainable
Please contact to person responsible for scientific inquiries.
What processes are involved for a request to access data/document
The data will be available through email and researcher permission.
Comments
Please contact to both email address: modanloo1@yahoo.com
modanloo.mahnaz@goums.ac.ir