Determining the effect of palliative care at home on the quality of life of the elderly with heart failure discharged from heart wards
Design
Randomized clinical trial with control group, with parallel groups, without blinding
Settings and conduct
Selection of 100 patients with heart failure referred to the cardiac ward of Kerman University of Medical Sciences and divided into two groups of control and intervention
Participants/Inclusion and exclusion criteria
1.The elderly with a definitive diagnosis of chronic heart failure by a cardiologist, class III or IV heart failure in the New York Heart Association classification. 2.Ability to communicate and no speech or hearing problems. 3.Have the mental ability to complete the questionnaire. 4.No mental illness and no use of drugs that affect the psyche. Exclusion criteria: death or withdrawal of participants from the study, lack of cooperation during the research
Intervention groups
The main purpose of palliative care in patients includes pain relief, physical symptoms, patient support and giving The meaning and concept of life is the end of life. The pretest questionnaire will be provided to the patient and he/she will be asked to complete the questionnaire form. With prior coordination for home care from hospital to home and with a well timed schedule, patients in the intervention group will receive eight individual sessions twice a week for eight and a half hours, in addition to receiving routine medical care. But patients in the control group will receive only routine medical intervention during this period. Finally, after the last care session and 1 month after the intervention, the quality of life questionnaire is completed by both groups to assess the quality of life.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211213053389N1
Registration date:2022-02-19, 1400/11/30
Registration timing:prospective
Last update:2022-02-19, 1400/11/30
Update count:0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
mohammad hossein khajehpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 4703
Email address
khajehpoor_m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of palliative care at home on the quality of life of the elderly with heart failure discharged from the heart wards
Public title
The effect of palliative care at home on the quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly with a certain diagnosis of chronic heart failure
Ability to communicate and non - speech problems and hearing problems
Lack of mental illness
Full consciousness at the time of research
Willingness to participate in research
Exclusion criteria:
In case of unstable physical and emergency conditions (change in vital signs and inability of the patient to attend class)
Failure to attend more than two training sessions
Failure to answer more than a third of the questions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by continuous sampling, and patients will be divided into control and test groups by Block Balanced Randomization (BBR). The allocation sequence will be done using the free web system http://www.randomization.com/. In this way, the number of subjects in each block is determined by 5 people and the letter A will be considered for the control group and the letter B will be considered for the experimental group. The assignment sequence will be created for 100 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, the Allocation Concealment will be considered and observed. Based on the eligible samples, an envelope shuffling envelope will be randomly removed by the researcher, and the method of randomly assigning the research samples will be determined.
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 Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina Street, first Jihad Blvd., Somayeh intersection, Kerman
City
Kerman
Province
Kerman
Postal code
7815789957
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.KMU.REC.1400.633
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Quality of life score in the Ferrans and Powers quality of life index, cardiac version - IV
Timepoint
Measurement of quality of life at the beginning of the study (before the intervention), after the intervention and 1 month after the intervention
Method of measurement
Ferrans and Powers quality of life index, cardiac version - IV
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the initial visit, which will be performed jointly by a cardiologist and a researcher, in addition to receiving routine care in heart failure, they will be placed in palliative care twice a week for eight and a half hours in eight individual sessions. The educational content will first be narrated by experts in the field of palliative care to determine the validity and quality of education and then will be implemented by the researcher. The intervention includes the following topics: 1. Familiarity with heart failure, 2. Providing an introduction to the importance and necessity of self-care training in psychological and physical dimensions and monitoring symptoms, 3. Needs assessment of care of various organs of the body, physical effects, Psychology and Behavior of the Elderly and Family, 4. Assessing the Self-Care Ability, Stressful Situations, Social Interactions and the Elderly Relationship and Life and the Effects of Death Anxiety and Family Support and Emotional and Spiritual Support, 5. Implementing the Elderly and Family Client Education Programs Based on self-care needs, 6. Review coping strategies in stressful situations, and ways to cope with stress and depression, 7. Strengthen self-confidence, self-esteem, coping with anxiety and inefficiency. 8. At the end, review the previous sessions, prepare the family to complete the group sessions, focus on performing self-care activities. At the beginning of the sessions, patients will be members of the virtual groups. The researcher asks them to inform him / her if he / she has any questions about the research, and also asks the patients to express their successful and unsuccessful experiences in relation to the issues raised. Finally, after the intervention, patients will be followed for a month, during which the researcher will answer possible questions from patients in virtual groups.
Category
Behavior
2
Description
Control group: After the initial visit, which will be performed jointly by a cardiologist and a researcher, patients will be provided with routine care in heart failure.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Mahmoud Nekouei Moghaddam
Street address
Kowsar Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
Web page address
https://sh.kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malek Pour Afshar
Street address
Deputy of Research and Technology, The beginning of Ibn Sina Street, Somayeh Intersection (Tahmasb Abad), Kerman
City
Kerman
Province
Kerman
Postal code
7815789957
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Web page address
https://kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohammad hossein Khajehpoor
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
Email
Khajehpoor_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Esmat Nouhi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5119
Fax
Email
smnouhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad hossein Khajehpoor
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
Email
Khajehpoor_m@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available