Determining the effect of continuous care on self-care of the elderly with pacemakers
Design
Clinical trial with control and test groups, randomized quasi-experimental, sample size in each group of 40 people, heads or tails randomization method
Settings and conduct
He referred to the heart clinic of Imam Khomeini Hospital and among the eligible individuals were placed in the experimental and control groups using a simple random method. Telephone intervention in the experimental group will be performed by the researcher for 12 weeks (at least once a week). In addition, in each telephone conversation session, the content of the conversation will be recorded in the set form. It should be noted that during the intervention, the control group will not be subject to any intervention by the researcher. At the end of the intervention, both groups will again answer the same questionnaires that they answered at the beginning of the study as a pre-test, as a post-test and then will be collected.
Participants/Inclusion and exclusion criteria
Age 60 to 74 years (young elderly)
- Has a permanent pacemaker
- Access to the phone with caller ID at home
Lack of speech and hearing problems
Lack of advanced cardiovascular disease and other vital organs
- No history of receiving follow-up care using the phone
Death
- Reluctance to continue cooperation
- Disconnection of telephone communication for two weeks in the first month and for 3 weeks in the second and third month of intervention
Intervention groups
The experimental group includes the elderly with heart failure with pacemaker for whom telephone counseling intervention will be performed for 12 weeks and also the control group includes the elderly with heart failure with pacemaker who during the intervention of the control group under no intervention. Will not be placed by the researcher.
Main outcome variables
Self-care management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201103049253N1
Registration date:2021-02-07, 1399/11/19
Registration timing:retrospective
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Mohammad Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5573 0315
Email address
mohammadaminitaha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-07-23, 1398/05/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
The effect of implementing continuous care model on self-care management of the elderly with pacemakers
Public title
Investigating the effect of caring for the elderly with pacemakers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 74 years (young elderly)
Has a permanent pacemaker
At least 24 hours have elapsed since the pacemaker was installed
Access to a caller ID phone at home
No known mental disorders
Be literate
Exclusion criteria:
Reluctance to continue cooperation
Telephone disconnection for two weeks in the first month and for 3 weeks in the second and third months of the intervention
Becoming serious or causing any serious disruption affecting the research process
Age
From 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization that the samples will be randomly placed in the control and test groups using the heads or tails method.
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 Tehran University of Medical Sciences
Street address
Dr. Mirkhani Ave., (Eastern Nusrat)., Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-04-21, 1398/02/01
Ethics committee reference number
IR.TUMS.FNM.REC.1398.007
Health conditions studied
1
Description of health condition studied
Heart failure, pacemaker
ICD-10 code
Z95.0
ICD-10 code description
Presence of cardiac pacemaker
Primary outcomes
1
Description
Self-care
Timepoint
At the beginning of the study and then for 12 weeks and at least once a week
Method of measurement
Primary questionnaire and self-care questionnaire for the elderly with pacemakers
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 40 elderly people with heart failure who have pacemakers. In this group, after filling in the initial questionnaire, the needs of the pacemaker will be assessed in relation to their educational needs and the items they feel the need to learn. Then, the telephone intervention in the experimental group will be performed by the researcher for 12 weeks. will be.; The content of the conversations will include: advice and training necessary to care for the pacemaker and control the infection, how to use the correct medication, appropriate activities for the elderly with pacemakers, and finally to provide a suggested solution and answer possible questions that come with it. The elderly will be involved. The content of the conversation will be recorded in the set form. Finally, the information of the two groups will be collected in the form of a post-test questionnaire.
Category
Rehabilitation
2
Description
Control group: 40 elderly people with heart failure who have a pacemaker. During the intervention, the control group will not be subject to any intervention by the researcher and only their information will be collected by demographic questionnaire and researcher-made questionnaire related to self-care of patients with pacemakers in the form of pretest and post-test.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Amini
Street address
Dr. Mirkhani Ave., (Eastern Nusrat)., Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Fax
+98 21 6690 4252
Email
fnm@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Granmayeh
Street address
Dr. Mirkhani Ave., (Eastern Nusrat)., Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Email
fnm-researchdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amini
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Ave., (Eastern Nusrat)., Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Email
fnm@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amini
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Ave., (Eastern Nusrat)., Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Email
mohammadaminitaha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amini
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Ave., (Eastern Nusrat)., Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Email
Mohammadaminitaha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available